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
-
mode(required): string
Mode of the study, accepts: test, active, or training
-
studyId(required): string
ID of the study
Query Parameters
-
excludeHiddenData: string
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.
-
fileType: string
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. -
fromTimestamp: string
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.
-
includeCOExtensions: string
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.
-
limit: integer(int32)
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.
-
offset: integer(int32)
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.
-
toTimestamp: string
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 TopResponse
Supported Media Types
- application/xml
- application/json
200 Response
Successful operation
Root Schema : ODM
Type:
Show Source
object
-
archival: string
Allowed Values:
[ "YES" ]
-
asOfDateTime: string
(date-time)
-
clinicalData: array
clinicalData
-
count: integer
(int32)
-
creationDateTime: string
(date-time)
-
description: string
-
excludeHiddenData: string
-
fileOID: string
-
fileType: string
Allowed Values:
[ "SNAPSHOT", "TRANSACTIONAL" ]
-
fromDate: string
(date-time)
-
granularity: string
Allowed Values:
[ "ALL", "METADATA", "ADMIN_DATA", "REFERENCE_DATA", "ALL_CLINICAL_DATA", "SINGLE_SITE", "SINGLE_SUBJECT" ]
-
hasMore: boolean
-
id: string
-
includeCOExtensions: string
-
includeLocations: string
-
includeUsers: string
-
limit: integer
(int32)
-
odmVersion: string
-
offset: integer
(int32)
-
originator: string
-
priorFileOID: string
-
sourceSystem: string
-
sourceSystemVersion: string
-
studyMode: string
-
studyVersion: string
-
studyVersionSummary: boolean
-
toDate: string
(date-time)
-
totalResults: integer
(int32)
Nested Schema : Annotation
Type:
Show Source
object
-
comment: object
Comment
-
flag: array
Flag
-
id: string
-
seqNum: integer
-
transactionType: string
Allowed Values:
[ "INSERT", "UPDATE", "REMOVE", "UPSERT", "CONTEXT" ]
Nested Schema : Comment
Type:
Show Source
object
-
sponsorOrSite: string
Allowed Values:
[ "SPONSOR", "SITE" ]
-
value: string
Nested Schema : AuditRecord
Type:
Show Source
object
-
dateTimeStamp(required): object
DateTimeStamp
-
editPoint: string
Allowed Values:
[ "MONITORING", "DATA_MANAGEMENT", "DB_AUDIT" ]
-
id: string
-
locationRef(required): object
LocationRef
-
reasonForChange: object
ReasonForChange
-
sourceID: object
SourceID
-
usedImputationMethod: string
Allowed Values:
[ "YES", "NO" ]
-
userRef(required): object
UserRef
Nested Schema : SubjectData
Type:
Show Source
object
-
annotation: array
Annotation
-
auditRecord: object
AuditRecord
-
investigatorRef: object
InvestigatorRef
-
signature: object
Signature
-
siteRef: object
SiteRef
-
studyEventData: array
studyEventData
-
subjectKey: string
-
transactionType: string
Allowed Values:
[ "INSERT", "UPDATE", "REMOVE", "UPSERT", "CONTEXT" ]
Nested Schema : StudyEventData
Type:
Show Source
object
-
annotation: array
Annotation
-
auditRecord: object
AuditRecord
-
formData: array
formData
-
signature: object
Signature
-
studyEventOID: string
-
studyEventRepeatKey: string
-
transactionType: string
Allowed Values:
[ "INSERT", "UPDATE", "REMOVE", "UPSERT", "CONTEXT" ]
Nested Schema : FormData
Type:
Show Source
object
-
annotation: array
Annotation
-
archiveLayoutRef: object
ArchiveLayoutRef
-
auditRecord: object
AuditRecord
-
formOID: string
-
formRepeatKey: string
-
itemGroupData: array
itemGroupData
-
signature: object
Signature
-
transactionType: string
Allowed Values:
[ "INSERT", "UPDATE", "REMOVE", "UPSERT", "CONTEXT" ]
Nested Schema : ItemGroupData
Type:
Show Source
object
-
annotation: array
Annotation
-
auditRecord: object
AuditRecord
-
itemDataGroup: array
itemDataGroup
-
itemDataStarGroup: array
itemDataStarGroup
-
itemGroupOID: string
-
itemGroupRepeatKey: string
-
signature: object
Signature
-
transactionType: string
Allowed Values:
[ "INSERT", "UPDATE", "REMOVE", "UPSERT", "CONTEXT" ]
Nested Schema : ItemData
Type:
Show Source
object
-
annotation: array
Annotation
-
auditRecord: object
AuditRecord
-
isNull: string
Allowed Values:
[ "YES" ]
-
itemOID: string
-
measurementUnitRef: object
MeasurementUnitRef
-
signature: object
Signature
-
transactionType: string
Allowed Values:
[ "INSERT", "UPDATE", "REMOVE", "UPSERT", "CONTEXT" ]
-
value: string
Nested Schema : items
Type:
object
400 Response
'Missing / invalid data'
Nested Schema : result
Type:
object
Nested Schema : details
Type:
object