ODM extract for clinical data with hidden data

get

/ec-datahub-svc/rest/v9.0/studies/{studyId}/{mode}/odm/clinicalData/unblinded

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.

Request

Path Parameters
Query Parameters
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

There's no request body for this operation.

Back to Top

Response

Supported Media Types

200 Response

Successful operation
Body ()
Root Schema : ODM
Type: object
Show Source
Nested Schema : clinicalData
Type: array
Show Source
Nested Schema : ClinicalData
Type: object
Show Source
Nested Schema : Annotations
Type: array
Show Source
Nested Schema : AuditRecords
Type: array
Show Source
Nested Schema : Signatures
Type: array
Show Source
Nested Schema : subjectData
Type: array
Show Source
Nested Schema : Annotations
Type: object
Show Source
Nested Schema : Annotation
Type: array
Show Source
Nested Schema : Annotation
Type: object
Show Source
Nested Schema : Comment
Type: object
Show Source
Nested Schema : Flag
Type: array
Show Source
Nested Schema : Flag
Type: object
Show Source
Nested Schema : FlagType
Type: object
Show Source
Nested Schema : FlagValue
Type: object
Show Source
Nested Schema : AuditRecords
Type: object
Show Source
Nested Schema : AuditRecord
Type: array
Show Source
Nested Schema : AuditRecord
Type: object
Show Source
Nested Schema : DateTimeStamp
Type: object
Show Source
Nested Schema : LocationRef
Type: object
Show Source
Nested Schema : ReasonForChange
Type: object
Show Source
Nested Schema : SourceID
Type: object
Show Source
Nested Schema : UserRef
Type: object
Show Source
Nested Schema : Signatures
Type: object
Show Source
Nested Schema : Signature
Type: array
Show Source
Nested Schema : Signature
Type: object
Show Source
Nested Schema : CryptoBindingManifest
Type: object
Show Source
Nested Schema : SignatureRef
Type: object
Show Source
Nested Schema : SubjectData
Type: object
Show Source
Nested Schema : Annotation
Type: array
Show Source
Nested Schema : InvestigatorRef
Type: object
Show Source
Nested Schema : SiteRef
Type: object
Show Source
Nested Schema : studyEventData
Type: array
Show Source
Nested Schema : StudyEventData
Type: object
Show Source
Nested Schema : Annotation
Type: array
Show Source
Nested Schema : formData
Type: array
Show Source
Nested Schema : FormData
Type: object
Show Source
Nested Schema : Annotation
Type: array
Show Source
Nested Schema : ArchiveLayoutRef
Type: object
Show Source
Nested Schema : itemGroupData
Type: array
Show Source
Nested Schema : ItemGroupData
Type: object
Show Source
Nested Schema : Annotation
Type: array
Show Source
Nested Schema : itemDataGroup
Type: array
Show Source
Nested Schema : itemDataStarGroup
Type: array
Show Source
Nested Schema : ItemData
Type: object
Show Source
Nested Schema : Annotation
Type: array
Show Source
Nested Schema : MeasurementUnitRef
Type: object
Show Source
Nested Schema : items
Type: object

400 Response

'Missing / invalid data'
Body ()
Root Schema : DataHubResponse
Type: object
Show Source
Nested Schema : ErrorResponseData
Type: object
Show Source
Nested Schema : result
Type: object
Nested Schema : details
Type: object
Back to Top