ODM extract for clinical data without hidden data

get

/ec-datahub-svc/rest/v11.0/studies/{studyId}/{mode}/odm/clinicalData/blinded

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.

Request

Path Parameters
Query Parameters
  • 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.
    Example:
    Snapshot
  • 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.
    Example:
    2023-01-01T00:00:00.000Z
  • 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.
    Example:
    true
  • Minimum Value: 1
    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.
    Example:
    50
  • Minimum Value: 0
    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.
    Example:
    0
  • 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.
    Example:
    2099-01-01T00:00:00.000Z

There's no request body for this operation.

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Response

Supported Media Types

200 Response

Successful operation
Body ()
Root Schema : ODM
Type: object
CDISC ODM v1.3.2 Clinical Data response with Clinical One specific extensions for v11.0. Contains pagination, filtering attributes and ClinicalData elements.
Show Source
Example:
<?xmlversion="1.0"?>
<ODM
	xmlns="http://www.cdisc.org/ns/odm/v1.3"
	xmlns:co="https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1"
	xmlns:ns0="http://www.w3.org/2000/09/xmldsig#"Description="STUDY01"FileType="Snapshot"FileOID="oracle/STUDY01/CB7500366CC3437BA7FD983A6EBFA926"CreationDateTime="2025-10-30T21:13:24.921Z"ODMVersion="1.3.2"Originator="system"SourceSystem="Oracle Life Sciences Clinical One"SourceSystemVersion="Clinical Data Unblinded API v11.0"co:studyMode="test"co:includeCOExtensions="true"co:excludeHiddenData="true"co:fromTimestamp="2023-01-01T00:00:00Z"co:toTimestamp="2050-01-01T23:59:59.999Z"co:hasMore="true"co:totalResults="19"co:count="1"co:limit="1"co:offset="0">
	<ClinicalDataStudyOID="STUDY01"MetaDataVersionOID="1.0.0.2"co:StudyID="0C7CBA3F70034C47947E2FAB086BFBF5"co:StudyVersionStart="2025-10-29T13:01:17.592Z">
		<SubjectDataSubjectKey="DATAHUB_AUT_Site2_Active01"co:SubjectGUID="C6A18791060849BBBAE1F7A16A62B389"co:SubjectStatus="Screening_Initiated"co:SubjectAction="Screened"co:ScreeningNumber="DATAHUB_AUT_Site2_Active01">
			<AuditRecord>
				<UserRefUserOID="testuser3">
				</UserRef>
				<LocationRefLocationOID="DATAHUB_AUT_Site2_Active">
				</LocationRef>
				<DateTimeStamp>2025-10-29T13:31:11.301Z</DateTimeStamp>
			</AuditRecord>
			<SiteRefLocationOID="DATAHUB_AUT_Site2_Active"co:Country="US">
			</SiteRef>
		</SubjectData>
	</ClinicalData>
	<ClinicalDataStudyOID="STUDY01"MetaDataVersionOID="1.0.0.2"co:StudyID="0C7CBA3F70034C47947E2FAB086BFBF5"co:StudyVersionStart="2025-10-29T13:01:17.592Z">
		<SubjectDataSubjectKey="DATAHUB_AUT_Site2_Active01"co:SubjectGUID="C6A18791060849BBBAE1F7A16A62B389">
			<StudyEventDataStudyEventOID="SCR_FD227430BECA4DECA5EA8B0E4DBE18CA"co:VisitGUID="FD227430BECA4DECA5EA8B0E4DBE18CA"co:VisitSequence="0"co:VisitStatus="COMPLETE"co:VisitName="ScreeningForm"co:VisitStartDate="2025-10-29T00:00:00.000Z">
				<AuditRecord>
					<UserRefUserOID="testuser3">
					</UserRef>
					<LocationRefLocationOID="DATAHUB_AUT_Site2_Active">
					</LocationRef>
					<DateTimeStamp>2025-10-29T13:31:11.372Z</DateTimeStamp>
				</AuditRecord>
			</StudyEventData>
		</SubjectData>
	</ClinicalData>
	<ClinicalDataStudyOID="STUDY01"MetaDataVersionOID="1.0.0.2"co:StudyID="0C7CBA3F70034C47947E2FAB086BFBF5"co:StudyVersionStart="2025-10-29T13:01:17.592Z">
		<SubjectDataSubjectKey="DATAHUB_AUT_Site2_Active01"co:SubjectGUID="C6A18791060849BBBAE1F7A16A62B389">
			<StudyEventDataStudyEventOID="Baseline_5DF278EB00F24820B9CEFE7BFD7A3078"co:VisitGUID="5DF278EB00F24820B9CEFE7BFD7A3078"co:VisitSequence="24"co:VisitStatus="INPROGRESS"co:VisitName="Baseline"co:VisitStartDate="2025-10-29T00:00:00.000Z">
				<AuditRecord>
					<UserRefUserOID="testuser3">
					</UserRef>
					<LocationRefLocationOID="DATAHUB_AUT_Site2_Active">
					</LocationRef>
					<DateTimeStamp>2025-10-29T13:43:28.354Z</DateTimeStamp>
				</AuditRecord>
			</StudyEventData>
		</SubjectData>
	</ClinicalData>
	<ClinicalDataStudyOID="STUDY01"MetaDataVersionOID="1.0.0.2"co:StudyID="0C7CBA3F70034C47947E2FAB086BFBF5"co:StudyVersionStart="2025-10-29T13:01:17.592Z">
		<SubjectDataSubjectKey="DATAHUB_AUT_Site2_Active01"co:SubjectGUID="C6A18791060849BBBAE1F7A16A62B389">
			<StudyEventDataStudyEventOID="Week1_3279AFB1AA3C44CFB6D6C419AAAC8A84"co:VisitGUID="3279AFB1AA3C44CFB6D6C419AAAC8A84"co:VisitSequence="360"co:VisitStatus="NEW"co:VisitName="Week1">
				<AuditRecord>
					<UserRefUserOID="testuser3">
					</UserRef>
					<LocationRefLocationOID="DATAHUB_AUT_Site2_Active">
					</LocationRef>
					<DateTimeStamp>2025-10-29T13:50:50.244Z</DateTimeStamp>
				</AuditRecord>
			</StudyEventData>
		</SubjectData>
	</ClinicalData>
	<ClinicalDataStudyOID="STUDY01"MetaDataVersionOID="1.0.0.2"co:StudyID="0C7CBA3F70034C47947E2FAB086BFBF5"co:StudyVersionStart="2025-10-29T13:01:17.592Z">
		<SubjectDataSubjectKey="DATAHUB_AUT_Site2_Active01"co:SubjectGUID="C6A18791060849BBBAE1F7A16A62B389">
			<SiteRefLocationOID="DATAHUB_AUT_Site2_Active"co:Country="US">
			</SiteRef>
			<StudyEventDataStudyEventOID="SCR_FD227430BECA4DECA5EA8B0E4DBE18CA"co:VisitGUID="FD227430BECA4DECA5EA8B0E4DBE18CA"co:VisitSequence="0"co:VisitName="ScreeningForm">
				<FormDataFormOID="FORM_02_FC21BE51B8424A54907F2F3672E72C29"co:FormGUID="FC21BE51B8424A54907F2F3672E72C29"co:FormStatus="COMPLETED">
					<ItemGroupDataItemGroupOID="SUBJECT_INITIALS_CF149710CBE24A6BB9266E52B5F5BA0F"co:ItemGroupGUID="CF149710CBE24A6BB9266E52B5F5BA0F">
						<ItemDataItemOID="SUBJECT_INITIALS_CF149710CBE24A6BB9266E52B5F5BA0F"TransactionType="Upsert"Value="ABC"co:ItemGUID="CF149710CBE24A6BB9266E52B5F5BA0F"co:DecodedValue="ABC"co:ValidationStatus="SUCCESS"co:SDVSelectionStatus="OBLIGATORY">
							<AuditRecord>
								<UserRefUserOID="testuser3">
								</UserRef>
								<LocationRefLocationOID="DATAHUB_AUT_Site2_Active">
								</LocationRef>
								<DateTimeStamp>2025-10-29T13:30:09.355Z</DateTimeStamp>
							</AuditRecord>
						</ItemData>
					</ItemGroupData>
				</FormData>
			</StudyEventData>
		</SubjectData>
	</ClinicalData>
	<ClinicalDataStudyOID="STUDY01"MetaDataVersionOID="1.0.0.2"co:StudyID="0C7CBA3F70034C47947E2FAB086BFBF5"co:StudyVersionStart="2025-10-29T13:01:17.592Z">
		<SubjectDataSubjectKey="DATAHUB_AUT_Site2_Active01"co:SubjectGUID="C6A18791060849BBBAE1F7A16A62B389">
			<SiteRefLocationOID="DATAHUB_AUT_Site2_Active"co:Country="US">
			</SiteRef>
			<StudyEventDataStudyEventOID="SCR_FD227430BECA4DECA5EA8B0E4DBE18CA"co:VisitGUID="FD227430BECA4DECA5EA8B0E4DBE18CA"co:VisitSequence="0"co:VisitName="ScreeningForm">
				<FormDataFormOID="FORM_02_FC21BE51B8424A54907F2F3672E72C29"co:FormGUID="FC21BE51B8424A54907F2F3672E72C29"co:FormStatus="COMPLETED">
					<ItemGroupDataItemGroupOID="DATETIME_02_528E107E03E84E5EB7558F6696C05758"co:ItemGroupGUID="528E107E03E84E5EB7558F6696C05758">
						<ItemDataItemOID="DATETIME_02_528E107E03E84E5EB7558F6696C05758"TransactionType="Upsert"Value="09-Nov-2020 00:00"co:ItemGUID="528E107E03E84E5EB7558F6696C05758"co:DecodedValue="09-Nov-2020 00:00"co:ValidationStatus="SUCCESS"co:SDVSelectionStatus="OBLIGATORY">
							<AuditRecord>
								<UserRefUserOID="testuser3">
								</UserRef>
								<LocationRefLocationOID="DATAHUB_AUT_Site2_Active">
								</LocationRef>
								<DateTimeStamp>2025-10-29T13:30:09.393Z</DateTimeStamp>
							</AuditRecord>
						</ItemData>
					</ItemGroupData>
				</FormData>
			</StudyEventData>
		</SubjectData>
	</ClinicalData>
	<ClinicalDataStudyOID="STUDY01"MetaDataVersionOID="1.0.0.2"co:StudyID="0C7CBA3F70034C47947E2FAB086BFBF5"co:StudyVersionStart="2025-10-29T13:01:17.592Z">
		<SubjectDataSubjectKey="DATAHUB_AUT_Site2_Active01"co:SubjectGUID="C6A18791060849BBBAE1F7A16A62B389">
			<SiteRefLocationOID="DATAHUB_AUT_Site2_Active"co:Country="US">
			</SiteRef>
			<StudyEventDataStudyEventOID="Baseline_5DF278EB00F24820B9CEFE7BFD7A3078"co:VisitGUID="5DF278EB00F24820B9CEFE7BFD7A3078"co:VisitSequence="24"co:VisitName="Baseline">
				<FormDataFormOID="DEMOG_3DC0796D51654FEBA0F1ED98EBE8A73B"co:FormGUID="3DC0796D51654FEBA0F1ED98EBE8A73B"co:FormStatus="COMPLETED">
					<ItemGroupDataItemGroupOID="IS_PREGNANT_94EDF14088B54C7AA78F6EE014F2AE61"co:ItemGroupGUID="94EDF14088B54C7AA78F6EE014F2AE61">
						<ItemDataItemOID="IS_PREGNANT_94EDF14088B54C7AA78F6EE014F2AE61"TransactionType="Upsert"Value="[{&quot;value&quot;:&quot;2&quot;,&quot;label&quot;:&quot;No&quot;}]"co:ItemGUID="94EDF14088B54C7AA78F6EE014F2AE61"co:DecodedValue="No"co:ValidationStatus="SUCCESS"co:SDVSelectionStatus="OBLIGATORY">
							<AuditRecord>
								<UserRefUserOID="testuser3">
								</UserRef>
								<LocationRefLocationOID="DATAHUB_AUT_Site2_Active">
								</LocationRef>
								<DateTimeStamp>2025-10-29T13:43:24.615Z</DateTimeStamp>
							</AuditRecord>
						</ItemData>
					</ItemGroupData>
				</FormData>
			</StudyEventData>
		</SubjectData>
	</ClinicalData>
	<ClinicalDataStudyOID="STUDY01"MetaDataVersionOID="1.0.0.2"co:StudyID="0C7CBA3F70034C47947E2FAB086BFBF5"co:StudyVersionStart="2025-10-29T13:01:17.592Z">
		<SubjectDataSubjectKey="DATAHUB_AUT_Site2_Active01"co:SubjectGUID="C6A18791060849BBBAE1F7A16A62B389">
			<SiteRefLocationOID="DATAHUB_AUT_Site2_Active"co:Country="US">
			</SiteRef>
			<StudyEventDataStudyEventOID="Baseline_5DF278EB00F24820B9CEFE7BFD7A3078"co:VisitGUID="5DF278EB00F24820B9CEFE7BFD7A3078"co:VisitSequence="24"co:VisitName="Baseline">
				<FormDataFormOID="DEMOG_3DC0796D51654FEBA0F1ED98EBE8A73B"co:FormGUID="3DC0796D51654FEBA0F1ED98EBE8A73B"co:FormStatus="COMPLETED">
					<ItemGroupDataItemGroupOID="RACE_AA8E3292CE5646D696AF88915FCC216D"co:ItemGroupGUID="AA8E3292CE5646D696AF88915FCC216D">
						<ItemDataItemOID="RACE_AA8E3292CE5646D696AF88915FCC216D"TransactionType="Upsert"Value="[{&quot;value&quot;:&quot;1&quot;,&quot;label&quot;:&quot;NH&quot;}]"co:ItemGUID="AA8E3292CE5646D696AF88915FCC216D"co:DecodedValue="NH"co:ValidationStatus="SUCCESS"co:SDVSelectionStatus="OBLIGATORY">
							<AuditRecord>
								<UserRefUserOID="testuser3">
								</UserRef>
								<LocationRefLocationOID="DATAHUB_AUT_Site2_Active">
								</LocationRef>
								<DateTimeStamp>2025-10-29T13:43:24.623Z</DateTimeStamp>
							</AuditRecord>
						</ItemData>
					</ItemGroupData>
				</FormData>
			</StudyEventData>
		</SubjectData>
	</ClinicalData>
	<ClinicalDataStudyOID="STUDY01"MetaDataVersionOID="1.0.0.2"co:StudyID="0C7CBA3F70034C47947E2FAB086BFBF5"co:StudyVersionStart="2025-10-29T13:01:17.592Z">
		<SubjectDataSubjectKey="DATAHUB_AUT_Site2_Active01"co:SubjectGUID="C6A18791060849BBBAE1F7A16A62B389">
			<SiteRefLocationOID="DATAHUB_AUT_Site2_Active"co:Country="US">
			</SiteRef>
			<StudyEventDataStudyEventOID="Baseline_5DF278EB00F24820B9CEFE7BFD7A3078"co:VisitGUID="5DF278EB00F24820B9CEFE7BFD7A3078"co:VisitSequence="24"co:VisitName="Baseline">
				<FormDataFormOID="DEMOG_3DC0796D51654FEBA0F1ED98EBE8A73B"co:FormGUID="3DC0796D51654FEBA0F1ED98EBE8A73B"co:FormStatus="COMPLETED">
					<ItemGroupDataItemGroupOID="ABOUT_YOU_F968ED26EFB14784A8C6F801BB7597B0"co:ItemGroupGUID="F968ED26EFB14784A8C6F801BB7597B0">
						<ItemDataItemOID="ABOUT_YOU_F968ED26EFB14784A8C6F801BB7597B0"TransactionType="Upsert"Value="Xyz"co:ItemGUID="F968ED26EFB14784A8C6F801BB7597B0"co:DecodedValue="Xyz"co:ValidationStatus="SUCCESS"co:SDVSelectionStatus="OBLIGATORY">
							<AuditRecord>
								<UserRefUserOID="testuser3">
								</UserRef>
								<LocationRefLocationOID="DATAHUB_AUT_Site2_Active">
								</LocationRef>
								<DateTimeStamp>2025-10-29T13:43:24.628Z</DateTimeStamp>
							</AuditRecord>
						</ItemData>
					</ItemGroupData>
				</FormData>
			</StudyEventData>
		</SubjectData>
	</ClinicalData>
	<ClinicalDataStudyOID="STUDY01"MetaDataVersionOID="1.0.0.2"co:StudyID="0C7CBA3F70034C47947E2FAB086BFBF5"co:StudyVersionStart="2025-10-29T13:01:17.592Z">
		<SubjectDataSubjectKey="DATAHUB_AUT_Site2_Active01"co:SubjectGUID="C6A18791060849BBBAE1F7A16A62B389">
			<SiteRefLocationOID="DATAHUB_AUT_Site2_Active"co:Country="US">
			</SiteRef>
			<StudyEventDataStudyEventOID="Baseline_5DF278EB00F24820B9CEFE7BFD7A3078"co:VisitGUID="5DF278EB00F24820B9CEFE7BFD7A3078"co:VisitSequence="24"co:VisitName="Baseline">
				<FormDataFormOID="DEMOG_3DC0796D51654FEBA0F1ED98EBE8A73B"co:FormGUID="3DC0796D51654FEBA0F1ED98EBE8A73B"co:FormStatus="COMPLETED">
					<ItemGroupDataItemGroupOID="GENDER_LAB_3C28F7079BE14AB0AF05F99367203658"co:ItemGroupGUID="3C28F7079BE14AB0AF05F99367203658">
						<ItemDataItemOID="GENDER_LAB_3C28F7079BE14AB0AF05F99367203658"TransactionType="Upsert"Value="[{&quot;value&quot;:&quot;1&quot;,&quot;label&quot;:&quot;Male&quot;}]"co:ItemGUID="3C28F7079BE14AB0AF05F99367203658"co:DecodedValue="Male"co:ValidationStatus="SUCCESS"co:SDVSelectionStatus="OBLIGATORY">
							<AuditRecord>
								<UserRefUserOID="testuser3">
								</UserRef>
								<LocationRefLocationOID="DATAHUB_AUT_Site2_Active">
								</LocationRef>
								<DateTimeStamp>2025-10-29T13:43:24.633Z</DateTimeStamp>
							</AuditRecord>
						</ItemData>
					</ItemGroupData>
				</FormData>
			</StudyEventData>
		</SubjectData>
	</ClinicalData>
	<ClinicalDataStudyOID="STUDY01"MetaDataVersionOID="1.0.0.2"co:StudyID="0C7CBA3F70034C47947E2FAB086BFBF5"co:StudyVersionStart="2025-10-29T13:01:17.592Z">
		<SubjectDataSubjectKey="DATAHUB_AUT_Site2_Active01"co:SubjectGUID="C6A18791060849BBBAE1F7A16A62B389">
			<SiteRefLocationOID="DATAHUB_AUT_Site2_Active"co:Country="US">
			</SiteRef>
			<StudyEventDataStudyEventOID="Baseline_5DF278EB00F24820B9CEFE7BFD7A3078"co:VisitGUID="5DF278EB00F24820B9CEFE7BFD7A3078"co:VisitSequence="24"co:VisitName="Baseline">
				<FormDataFormOID="DEMOG_3DC0796D51654FEBA0F1ED98EBE8A73B"co:FormGUID="3DC0796D51654FEBA0F1ED98EBE8A73B"co:FormStatus="COMPLETED">
					<ItemGroupDataItemGroupOID="SMARTITEM_06_DOB_5EED4980C8A6431697432F0915219916"co:ItemGroupGUID="5EED4980C8A6431697432F0915219916">
						<ItemDataItemOID="SMARTITEM_06_DOB_5EED4980C8A6431697432F0915219916"TransactionType="Upsert"Value="07-May-1991"co:ItemGUID="5EED4980C8A6431697432F0915219916"co:DecodedValue="07-May-1991"co:ValidationStatus="SUCCESS"co:SDVSelectionStatus="OBLIGATORY">
							<AuditRecord>
								<UserRefUserOID="testuser3">
								</UserRef>
								<LocationRefLocationOID="DATAHUB_AUT_Site2_Active">
								</LocationRef>
								<DateTimeStamp>2025-10-29T13:43:24.649Z</DateTimeStamp>
							</AuditRecord>
						</ItemData>
					</ItemGroupData>
				</FormData>
			</StudyEventData>
		</SubjectData>
	</ClinicalData>
	<ClinicalDataStudyOID="STUDY01"MetaDataVersionOID="1.0.0.2"co:StudyID="0C7CBA3F70034C47947E2FAB086BFBF5"co:StudyVersionStart="2025-10-29T13:01:17.592Z">
		<SubjectDataSubjectKey="DATAHUB_AUT_Site2_Active01"co:SubjectGUID="C6A18791060849BBBAE1F7A16A62B389">
			<SiteRefLocationOID="DATAHUB_AUT_Site2_Active"co:Country="US">
			</SiteRef>
			<StudyEventDataStudyEventOID="Baseline_5DF278EB00F24820B9CEFE7BFD7A3078"co:VisitGUID="5DF278EB00F24820B9CEFE7BFD7A3078"co:VisitSequence="24"co:VisitName="Baseline">
				<FormDataFormOID="DEMOG_3DC0796D51654FEBA0F1ED98EBE8A73B"co:FormGUID="3DC0796D51654FEBA0F1ED98EBE8A73B"co:FormStatus="COMPLETED">
					<ItemGroupDataItemGroupOID="RACE_LAB_F0AD42619DE14BCABD6EF726EC7C1BFD"co:ItemGroupGUID="F0AD42619DE14BCABD6EF726EC7C1BFD">
						<ItemDataItemOID="RACE_LAB_F0AD42619DE14BCABD6EF726EC7C1BFD"TransactionType="Upsert"Value="[{&quot;value&quot;:&quot;1&quot;,&quot;label&quot;:&quot;African American&quot;}]"co:ItemGUID="F0AD42619DE14BCABD6EF726EC7C1BFD"co:DecodedValue="African American"co:ValidationStatus="SUCCESS"co:SDVSelectionStatus="OBLIGATORY">
							<AuditRecord>
								<UserRefUserOID="testuser3">
								</UserRef>
								<LocationRefLocationOID="DATAHUB_AUT_Site2_Active">
								</LocationRef>
								<DateTimeStamp>2025-10-29T13:43:24.656Z</DateTimeStamp>
							</AuditRecord>
						</ItemData>
					</ItemGroupData>
				</FormData>
			</StudyEventData>
		</SubjectData>
	</ClinicalData>
	<ClinicalDataStudyOID="STUDY01"MetaDataVersionOID="1.0.0.2"co:StudyID="0C7CBA3F70034C47947E2FAB086BFBF5"co:StudyVersionStart="2025-10-29T13:01:17.592Z">
		<SubjectDataSubjectKey="DATAHUB_AUT_Site2_Active01"co:SubjectGUID="C6A18791060849BBBAE1F7A16A62B389">
			<SiteRefLocationOID="DATAHUB_AUT_Site2_Active"co:Country="US">
			</SiteRef>
			<StudyEventDataStudyEventOID="Baseline_5DF278EB00F24820B9CEFE7BFD7A3078"co:VisitGUID="5DF278EB00F24820B9CEFE7BFD7A3078"co:VisitSequence="24"co:VisitName="Baseline">
				<FormDataFormOID="PREGNANCY_E243611973104C1CB86F4EE3207F74CD"co:FormGUID="E243611973104C1CB86F4EE3207F74CD"co:FormStatus="COMPLETED">
					<ItemGroupDataItemGroupOID="IS_FIRST_DELIVERY_0826A6111AFC42D6B4FCD89752A38A7F"co:ItemGroupGUID="0826A6111AFC42D6B4FCD89752A38A7F">
						<ItemDataItemOID="IS_FIRST_DELIVERY_0826A6111AFC42D6B4FCD89752A38A7F"TransactionType="Upsert"Value="[{&quot;value&quot;:&quot;2&quot;,&quot;label&quot;:&quot;No&quot;}]"co:ItemGUID="0826A6111AFC42D6B4FCD89752A38A7F"co:DecodedValue="No"co:ValidationStatus="SUCCESS"co:SDVSelectionStatus="OBLIGATORY">
							<AuditRecord>
								<UserRefUserOID="testuser3">
								</UserRef>
								<LocationRefLocationOID="DATAHUB_AUT_Site2_Active">
								</LocationRef>
								<DateTimeStamp>2025-10-29T13:43:25.492Z</DateTimeStamp>
							</AuditRecord>
						</ItemData>
					</ItemGroupData>
				</FormData>
			</StudyEventData>
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			</StudyEventData>
		</SubjectData>
	</ClinicalData>
	<ClinicalDataStudyOID="STUDY01"MetaDataVersionOID="1.0.0.2"co:StudyID="0C7CBA3F70034C47947E2FAB086BFBF5"co:StudyVersionStart="2025-10-29T13:01:17.592Z">
		<SubjectDataSubjectKey="DATAHUB_AUT_Site2_Active01"co:SubjectGUID="C6A18791060849BBBAE1F7A16A62B389">
			<SiteRefLocationOID="DATAHUB_AUT_Site2_Active"co:Country="US">
			</SiteRef>
			<StudyEventDataStudyEventOID="Baseline_5DF278EB00F24820B9CEFE7BFD7A3078"co:VisitGUID="5DF278EB00F24820B9CEFE7BFD7A3078"co:VisitSequence="24"co:VisitName="Baseline">
				<FormDataFormOID="CONCOMITANT_MEDICATIONS_FORM_234478166C0D4394BA6FF6E4378D6AEF"FormRepeatKey="1"co:FormGUID="234478166C0D4394BA6FF6E4378D6AEF"co:FormStatus="COMPLETED"co:OuterRepeat="1">
					<ItemGroupDataItemGroupOID="TEXT_03_5E3AFE6B8C5B4D9F904C8EB48040CB84"co:ItemGroupGUID="5E3AFE6B8C5B4D9F904C8EB48040CB84">
						<ItemDataItemOID="TEXT_03_5E3AFE6B8C5B4D9F904C8EB48040CB84"TransactionType="Upsert"Value="covid treatment"co:ItemGUID="5E3AFE6B8C5B4D9F904C8EB48040CB84"co:DecodedValue="covid treatment"co:ValidationStatus="SUCCESS"co:SDVSelectionStatus="OBLIGATORY">
							<AuditRecord>
								<UserRefUserOID="testuser3">
								</UserRef>
								<LocationRefLocationOID="DATAHUB_AUT_Site2_Active">
								</LocationRef>
								<DateTimeStamp>2025-10-29T13:43:29.749Z</DateTimeStamp>
							</AuditRecord>
						</ItemData>
					</ItemGroupData>
				</FormData>
			</StudyEventData>
		</SubjectData>
	</ClinicalData>
	<ClinicalDataStudyOID="STUDY01"MetaDataVersionOID="1.0.0.2"co:StudyID="0C7CBA3F70034C47947E2FAB086BFBF5"co:StudyVersionStart="2025-10-29T13:01:17.592Z">
		<SubjectDataSubjectKey="DATAHUB_AUT_Site2_Active01"co:SubjectGUID="C6A18791060849BBBAE1F7A16A62B389">
			<SiteRefLocationOID="DATAHUB_AUT_Site2_Active"co:Country="US">
			</SiteRef>
			<StudyEventDataStudyEventOID="Baseline_5DF278EB00F24820B9CEFE7BFD7A3078"co:VisitGUID="5DF278EB00F24820B9CEFE7BFD7A3078"co:VisitSequence="24"co:VisitName="Baseline">
				<FormDataFormOID="CONCOMITANT_MEDICATIONS_FORM_234478166C0D4394BA6FF6E4378D6AEF"FormRepeatKey="1"co:FormGUID="234478166C0D4394BA6FF6E4378D6AEF"co:FormStatus="COMPLETED"co:OuterRepeat="1">
					<ItemGroupDataItemGroupOID="PRESCRIPTION_6F28953972164690A35B2563CF82523C"co:ItemGroupGUID="6F28953972164690A35B2563CF82523C">
						<ItemDataItemOID="PRESCRIPTION_6F28953972164690A35B2563CF82523C"TransactionType="Upsert"Value="[{&quot;value&quot;:&quot;1&quot;,&quot;label&quot;:&quot;Prescribed by Investigator&quot;}]"co:ItemGUID="6F28953972164690A35B2563CF82523C"co:DecodedValue="Prescribed by Investigator"co:ValidationStatus="SUCCESS"co:SDVSelectionStatus="OBLIGATORY">
							<AuditRecord>
								<UserRefUserOID="testuser3">
								</UserRef>
								<LocationRefLocationOID="DATAHUB_AUT_Site2_Active">
								</LocationRef>
								<DateTimeStamp>2025-10-29T13:43:29.759Z</DateTimeStamp>
							</AuditRecord>
						</ItemData>
					</ItemGroupData>
				</FormData>
			</StudyEventData>
		</SubjectData>
	</ClinicalData>
	<ClinicalDataStudyOID="STUDY01"MetaDataVersionOID="1.0.0.2"co:StudyID="0C7CBA3F70034C47947E2FAB086BFBF5"co:StudyVersionStart="2025-10-29T13:01:17.592Z">
		<SubjectDataSubjectKey="DATAHUB_AUT_Site2_Active01"co:SubjectGUID="C6A18791060849BBBAE1F7A16A62B389">
			<SiteRefLocationOID="DATAHUB_AUT_Site2_Active"co:Country="US">
			</SiteRef>
			<StudyEventDataStudyEventOID="Baseline_5DF278EB00F24820B9CEFE7BFD7A3078"co:VisitGUID="5DF278EB00F24820B9CEFE7BFD7A3078"co:VisitSequence="24"co:VisitName="Baseline">
				<FormDataFormOID="CONCOMITANT_MEDICATIONS_FORM_234478166C0D4394BA6FF6E4378D6AEF"FormRepeatKey="1"co:FormGUID="234478166C0D4394BA6FF6E4378D6AEF"co:FormStatus="COMPLETED"co:OuterRepeat="1">
					<ItemGroupDataItemGroupOID="DOSAGE_8CD9E77FD4784A499E122DCCA2517274"co:ItemGroupGUID="8CD9E77FD4784A499E122DCCA2517274">
						<ItemDataItemOID="DOSAGE_8CD9E77FD4784A499E122DCCA2517274"TransactionType="Upsert"Value="120"co:ItemGUID="8CD9E77FD4784A499E122DCCA2517274"co:DecodedValue="120"co:ValidationStatus="SUCCESS"co:SDVSelectionStatus="OBLIGATORY">
							<AuditRecord>
								<UserRefUserOID="testuser3">
								</UserRef>
								<LocationRefLocationOID="DATAHUB_AUT_Site2_Active">
								</LocationRef>
								<DateTimeStamp>2025-10-29T13:43:29.767Z</DateTimeStamp>
							</AuditRecord>
							<MeasurementUnitRefMeasurementUnitOID="mg">
							</MeasurementUnitRef>
						</ItemData>
					</ItemGroupData>
				</FormData>
			</StudyEventData>
		</SubjectData>
	</ClinicalData>
	<ClinicalDataStudyOID="STUDY01"MetaDataVersionOID="1.0.0.2"co:StudyID="0C7CBA3F70034C47947E2FAB086BFBF5"co:StudyVersionStart="2025-10-29T13:01:17.592Z">
		<SubjectDataSubjectKey="DATAHUB_AUT_Site2_Active01"co:SubjectGUID="C6A18791060849BBBAE1F7A16A62B389">
			<SiteRefLocationOID="DATAHUB_AUT_Site2_Active"co:Country="US">
			</SiteRef>
			<StudyEventDataStudyEventOID="Baseline_5DF278EB00F24820B9CEFE7BFD7A3078"co:VisitGUID="5DF278EB00F24820B9CEFE7BFD7A3078"co:VisitSequence="24"co:VisitName="Baseline">
				<FormDataFormOID="CONCOMITANT_MEDICATIONS_FORM_234478166C0D4394BA6FF6E4378D6AEF"FormRepeatKey="1"co:FormGUID="234478166C0D4394BA6FF6E4378D6AEF"co:FormStatus="COMPLETED"co:OuterRepeat="1">
					<ItemGroupDataItemGroupOID="DOSAGE_FREQUENCY_FED9EAB627E541EB9251F8CBB7FE3B46"co:ItemGroupGUID="FED9EAB627E541EB9251F8CBB7FE3B46">
						<ItemDataItemOID="DOSAGE_FREQUENCY_FED9EAB627E541EB9251F8CBB7FE3B46"TransactionType="Upsert"Value="[{&quot;value&quot;:&quot;2&quot;,&quot;label&quot;:&quot;Twice a day&quot;}]"co:ItemGUID="FED9EAB627E541EB9251F8CBB7FE3B46"co:DecodedValue="Twice a day"co:ValidationStatus="SUCCESS"co:SDVSelectionStatus="OBLIGATORY">
							<AuditRecord>
								<UserRefUserOID="testuser3">
								</UserRef>
								<LocationRefLocationOID="DATAHUB_AUT_Site2_Active">
								</LocationRef>
								<DateTimeStamp>2025-10-29T13:43:29.773Z</DateTimeStamp>
							</AuditRecord>
						</ItemData>
					</ItemGroupData>
				</FormData>
			</StudyEventData>
		</SubjectData>
	</ClinicalData>
	<ClinicalDataStudyOID="STUDY01"MetaDataVersionOID="1.0.0.2"co:StudyID="0C7CBA3F70034C47947E2FAB086BFBF5"co:StudyVersionStart="2025-10-29T13:01:17.592Z">
		<SubjectDataSubjectKey="DATAHUB_AUT_Site2_Active01"co:SubjectGUID="C6A18791060849BBBAE1F7A16A62B389">
			<SiteRefLocationOID="DATAHUB_AUT_Site2_Active"co:Country="US">
			</SiteRef>
			<StudyEventDataStudyEventOID="Baseline_5DF278EB00F24820B9CEFE7BFD7A3078"co:VisitGUID="5DF278EB00F24820B9CEFE7BFD7A3078"co:VisitSequence="24"co:VisitName="Baseline">
				<FormDataFormOID="CONCOMITANT_MEDICATIONS_FORM_234478166C0D4394BA6FF6E4378D6AEF"FormRepeatKey="1"co:FormGUID="234478166C0D4394BA6FF6E4378D6AEF"co:FormStatus="COMPLETED"co:OuterRepeat="1">
					<ItemGroupDataItemGroupOID="START_DATE_MEDICATION_9ABA8F3316FA4D6CAD019CF99A3B28CA"co:ItemGroupGUID="9ABA8F3316FA4D6CAD019CF99A3B28CA">
						<ItemDataItemOID="START_DATE_MEDICATION_9ABA8F3316FA4D6CAD019CF99A3B28CA"TransactionType="Upsert"Value="08-Jun-2022"co:ItemGUID="9ABA8F3316FA4D6CAD019CF99A3B28CA"co:DecodedValue="08-Jun-2022"co:ValidationStatus="SUCCESS"co:SDVSelectionStatus="OBLIGATORY">
							<AuditRecord>
								<UserRefUserOID="testuser3">
								</UserRef>
								<LocationRefLocationOID="DATAHUB_AUT_Site2_Active">
								</LocationRef>
								<DateTimeStamp>2025-10-29T13:43:29.779Z</DateTimeStamp>
							</AuditRecord>
						</ItemData>
					</ItemGroupData>
				</FormData>
			</StudyEventData>
		</SubjectData>
	</ClinicalData>
	<ClinicalDataStudyOID="STUDY01"MetaDataVersionOID="1.0.0.2"co:StudyID="0C7CBA3F70034C47947E2FAB086BFBF5"co:StudyVersionStart="2025-10-29T13:01:17.592Z">
		<SubjectDataSubjectKey="DATAHUB_AUT_Site2_Active01"co:SubjectGUID="C6A18791060849BBBAE1F7A16A62B389">
			<SiteRefLocationOID="DATAHUB_AUT_Site2_Active"co:Country="US">
			</SiteRef>
			<StudyEventDataStudyEventOID="Baseline_5DF278EB00F24820B9CEFE7BFD7A3078"co:VisitGUID="5DF278EB00F24820B9CEFE7BFD7A3078"co:VisitSequence="24"co:VisitName="Baseline">
				<FormDataFormOID="CONCOMITANT_MEDICATIONS_FORM_234478166C0D4394BA6FF6E4378D6AEF"FormRepeatKey="1"co:FormGUID="234478166C0D4394BA6FF6E4378D6AEF"co:FormStatus="COMPLETED"co:OuterRepeat="1">
					<ItemGroupDataItemGroupOID="STOP_DATE_MEDICATION_16C802F711504BED96EFF2198AD02A34"co:ItemGroupGUID="16C802F711504BED96EFF2198AD02A34">
						<ItemDataItemOID="STOP_DATE_MEDICATION_16C802F711504BED96EFF2198AD02A34"TransactionType="Upsert"Value="24-Jun-2022"co:ItemGUID="16C802F711504BED96EFF2198AD02A34"co:DecodedValue="24-Jun-2022"co:ValidationStatus="SUCCESS"co:SDVSelectionStatus="OBLIGATORY">
							<AuditRecord>
								<UserRefUserOID="testuser3">
								</UserRef>
								<LocationRefLocationOID="DATAHUB_AUT_Site2_Active">
								</LocationRef>
								<DateTimeStamp>2025-10-29T13:43:29.785Z</DateTimeStamp>
							</AuditRecord>
						</ItemData>
					</ItemGroupData>
				</FormData>
			</StudyEventData>
		</SubjectData>
	</ClinicalData>
	<ClinicalDataStudyOID="STUDY01"MetaDataVersionOID="1.0.0.2"co:StudyID="0C7CBA3F70034C47947E2FAB086BFBF5"co:StudyVersionStart="2025-10-29T13:01:17.592Z">
		<SubjectDataSubjectKey="DATAHUB_AUT_Site2_Active01"co:SubjectGUID="C6A18791060849BBBAE1F7A16A62B389">
			<SiteRefLocationOID="DATAHUB_AUT_Site2_Active"co:Country="US">
			</SiteRef>
			<StudyEventDataStudyEventOID="Baseline_5DF278EB00F24820B9CEFE7BFD7A3078"co:VisitGUID="5DF278EB00F24820B9CEFE7BFD7A3078"co:VisitSequence="24"co:VisitName="Baseline">
				<FormDataFormOID="DEMOG_3DC0796D51654FEBA0F1ED98EBE8A73B"co:FormGUID="3DC0796D51654FEBA0F1ED98EBE8A73B"co:FormStatus="COMPLETED">
					<ItemGroupDataItemGroupOID="GENDER_1A4A881F48114F51A7247CEBE773C521"co:ItemGroupGUID="1A4A881F48114F51A7247CEBE773C521">
						<ItemDataItemOID="GENDER_1A4A881F48114F51A7247CEBE773C521"TransactionType="Upsert"Value="[{&quot;value&quot;:&quot;2&quot;,&quot;label&quot;:&quot;Female&quot;}]"co:ItemGUID="1A4A881F48114F51A7247CEBE773C521"co:DecodedValue="Female"co:ValidationStatus="SUCCESS"co:SDVSelectionStatus="OBLIGATORY">
							<AuditRecord>
								<UserRefUserOID="testuser3">
								</UserRef>
								<LocationRefLocationOID="DATAHUB_AUT_Site2_Active">
								</LocationRef>
								<DateTimeStamp>2025-10-29T13:43:39.046Z</DateTimeStamp>
								<ReasonForChange>TranscriptionError</ReasonForChange>
							</AuditRecord>
						</ItemData>
					</ItemGroupData>
				</FormData>
			</StudyEventData>
		</SubjectData>
	</ClinicalData>
</ODM>
Nested Schema : ClinicalData
Type: object
List of ClinicalData elements describing study clinical content.
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
Annotation comment object
Show Source
Example:
{
    "value":"Requires follow-up"
}
Nested Schema : Flag
Type: object
Flags associated with this annotation
Show Source
Example:
[
    {
        "flagOID":"FLAG1"
    }
]
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
Timestamp of signing
Show Source
Example:
{
    "value":"2025-10-27T10:00:00Z"
}
Nested Schema : LocationRef
Type: object
Reference to a study/site location for an ODM User.
Show Source
Example:
{
    "locationOID":"LOC101"
}
Nested Schema : ReasonForChange
Type: object
Reason for data change
Show Source
Example:
{
    "value":"Correction"
}
Nested Schema : SourceID
Type: object
Source identifier
Show Source
Example:
{
    "value":"SYS"
}
Nested Schema : UserRef
Type: object
Reference to user
Show Source
Example:
{
    "userOID":"USER123"
}
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
Crypto binding manifest details
Show Source
Example:
{
    "manifestID":"CBM1"
}
Nested Schema : SignatureRef
Type: object
Reference to signature
Show Source
Example:
{
    "refID":"SIGREF1"
}
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 : SubjectHistory
Type: array
Show Source
Nested Schema : TransferData
Type: array
Show Source
Nested Schema : StudyEventData
Type: object
Show Source
Nested Schema : Annotation
Type: array
Show Source
Nested Schema : EventHistory
Type: array
Show Source
Nested Schema : FormData
Type: array
Show Source
Nested Schema : RepeatingFormSummary
Type: object
Show Source
Nested Schema : History
Type: object
Show Source
Nested Schema : details
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: object
Annotations for the item group
Show Source
Example:
[
    {
        "annotationOID":"AN1"
    }
]
Nested Schema : Items
Type: object
Contained item data list
Show Source
Example:
[
    {
        "itemOID":"ITM1"
    }
]
Nested Schema : Flag
Type: object
Flags associated with this annotation
Show Source
Example:
[
    {
        "flagOID":"FLAG1"
    }
]
Nested Schema : Annotation
Type: object
Annotations for this item
Show Source
Example:
[
    {
        "id":"AN1"
    }
]
Nested Schema : MeasurementUnitRef
Type: object
Measurement unit reference
Show Source
Example:
{
    "measurementUnitOID":"U1"
}
Nested Schema : Flag
Type: object
Flags associated with this annotation
Show Source
Example:
[
    {
        "flagOID":"FLAG1"
    }
]
Nested Schema : RepeatingFormData
Type: array
Show Source
Nested Schema : RepeatingFormData
Type: object
Show Source
Nested Schema : FormHeader
Type: array
Show Source
Nested Schema : Row
Type: array
Show Source
Nested Schema : FormHeader
Type: object
Show Source
Nested Schema : Row
Type: object
Show Source
Nested Schema : AssociatedFormList
Type: array
Show Source
Nested Schema : Item
Type: array
Show Source
Nested Schema : AssociatedFormList
Type: object
Show Source
Nested Schema : AuditTrail
Type: array
Show Source
Nested Schema : AuditTrail
Type: object
Show Source
Nested Schema : Item
Type: object
Show Source
Nested Schema : TransferData
Type: object
Show Source

400 Response

'Missing / invalid data'
Body ()
Root Schema : DataHubResponse
Type: object
Standard response envelope containing status, optional result payload, optional error information and a version number.
Show Source
Nested Schema : errorData
Type: object
Error details when status is error.
Example:
{
    "errorCode":"C1-003",
    "errorMessage":"Validation failed",
    "details":{
        "field":"limit",
        "message":"limit must be >= 1"
    }
}
Nested Schema : result
Type: object
Payload returned by the API when status is success.
Example:
{
    "message":"Operation succeeded"
}
Examples

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