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[Deprecated]: ODM extract for clinical data without hidden data

get

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

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.

Request

Path Parameters

• mode(required): string
  Mode of the study, accepts: test, active, or training.
• studyId(required): string
  Unique identifier (UUID, 32-character uppercase hexadecimal string) representing the study.

Query Parameters

• 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.

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Response

Supported Media Types

• application/xml
• application/json

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

• archival: string
  Allowed Values: [ "YES" ]

  Indicates archival state as per ODM YesOnly enumeration.

  Example: Yes
• asOfDateTime: string (date-time)
  Timestamp indicating as-of datetime for the extract.

  Example: 2023-06-05T12:34:56Z
• clinicalData: object ClinicalData
  List of ClinicalData elements describing study clinical content.
• count: integer (int32)
  Number of results returned in this response.

  Example: 50
• creationDateTime: string (date-time)
  Creation timestamp of the file.

  Example: 2023-06-05T12:34:56Z
• description: string
  Free text description of the file content.

  Example: Clinical data extract
• excludeHiddenData: boolean
  If true, data marked as hidden is excluded from the response.

  Example: true
• fileOID: string
  Unique file identifier.

  Example: B1A2C3D4E5F647B18123456789ABCDEF
• fileType: string
  Allowed Values: [ "SNAPSHOT", "TRANSACTIONAL", "Snapshot", "Transactional" ]

  ODM file type that indicates whether the export is a full snapshot or a transactional change set.

  Example: <ODM FileType="Snapshot"/>
• fromDate: string (date)
  Filter results from this timestamp (inclusive). RFC 3339 format.

  Example: 2023-01-01
• Granularity: string (string)
  Allowed Values: [ "ALL", "METADATA", "ADMIN_DATA", "REFERENCE_DATA", "ALL_CLINICAL_DATA", "SINGLE_SITE", "SINGLE_SUBJECT", "All", "Metadata", "AdminData", "ReferenceData", "AllClinicalData", "SingleSite", "SingleSubject" ]

  Granularity of ODM data export.

  Example: <Granularity>All</Granularity>
• hasMore: boolean
  Indicates if there are more records beyond the current page.

  Example: false
• id: string
  Unique identifier for the ODM document.

  Example: EC942244BB30163BE053BEC44C64CF34
• includeCOExtensions: boolean
  Indicates whether Clinical One specific extensions are included in the payload.

  Example: true
• includeLocations: boolean
  Whether to include location information.

  Example: false
• includeUsers: boolean
  Whether to include user information.

  Example: false
• limit: integer (int32)
  Minimum Value: 1

  Maximum number of items returned per page.

  Example: 50
• odmVersion: string
  ODM version used for the payload.

  Example: 1.3.2
• offset: integer (int32)
  Minimum Value: 0

  Zero-based index of the first item returned.

  Example: 0
• originator: string
  Originator of the data extract.

  Example: Clinical One
• priorFileOID: string
  Identifier of the prior file related to this extract.

  Example: C1D2E3F4A5B647B18123456789ABCDEF
• sourceSystem: string
  Source system from which the data is generated.

  Example: ClinicalOne
• sourceSystemVersion: string
  Version of the source system that generated the data.

  Example: Clinical Data Unblinded API v11.0
• studyMode: string
  Study mode context in which the data is extracted. Possible values are test, active or training.

  Example: active
• studyVersion: string
  Study version identifier from which the data is produced.

  Example: 1.0.0.1
• studyVersionSummary: boolean
  Indicates whether the study version summary is included.

  Example: false
• toDate: string (date)
  Filter results up to this timestamp (inclusive). RFC 3339 format.

  Example: 2023-12-31
• totalResults: integer (int32)
  Total number of results matching the request.

  Example: 100

{
    "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":"<ODM FileType=\"Snapshot\"/>",
            "xml":{
                "name":"FileType",
                "attribute":true
            },
            "enum":[
                "SNAPSHOT",
                "TRANSACTIONAL",
                "Snapshot",
                "Transactional"
            ]
        },
        "Granularity":{
            "type":"string",
            "description":"Granularity of ODM data export.",
            "format":"string",
            "example":"<Granularity>All</Granularity>",
            "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":"<?xmlversion=\"1.0\"?>\n<ODM\n\txmlns=\"http://www.cdisc.org/ns/odm/v1.3\"\n\txmlns:co=\"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1\"\n\txmlns: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\">\n\t<ClinicalDataStudyOID=\"STUDY01\"MetaDataVersionOID=\"1.0.0.2\"co:StudyID=\"0C7CBA3F70034C47947E2FAB086BFBF5\"co:StudyVersionStart=\"2025-10-29T13:01:17.592Z\">\n\t\t<SubjectDataSubjectKey=\"DATAHUB_AUT_Site2_Active01\"co:SubjectGUID=\"C6A18791060849BBBAE1F7A16A62B389\"co:SubjectStatus=\"Screening_Initiated\"co:SubjectAction=\"Screened\"co:ScreeningNumber=\"DATAHUB_AUT_Site2_Active01\">\n\t\t\t<AuditRecord>\n\t\t\t\t<UserRefUserOID=\"testuser3\">\n\t\t\t\t</UserRef>\n\t\t\t\t<LocationRefLocationOID=\"DATAHUB_AUT_Site2_Active\">\n\t\t\t\t</LocationRef>\n\t\t\t\t<DateTimeStamp>2025-10-29T13:31:11.301Z</DateTimeStamp>\n\t\t\t</AuditRecord>\n\t\t\t<SiteRefLocationOID=\"DATAHUB_AUT_Site2_Active\"co:Country=\"US\">\n\t\t\t</SiteRef>\n\t\t</SubjectData>\n\t</ClinicalData>\n\t<ClinicalDataStudyOID=\"STUDY01\"MetaDataVersionOID=\"1.0.0.2\"co:StudyID=\"0C7CBA3F70034C47947E2FAB086BFBF5\"co:StudyVersionStart=\"2025-10-29T13:01:17.592Z\">\n\t\t<SubjectDataSubjectKey=\"DATAHUB_AUT_Site2_Active01\"co:SubjectGUID=\"C6A18791060849BBBAE1F7A16A62B389\">\n\t\t\t<StudyEventDataStudyEventOID=\"SCR_FD227430BECA4DECA5EA8B0E4DBE18CA\"co:VisitGUID=\"FD227430BECA4DECA5EA8B0E4DBE18CA\"co:VisitSequence=\"0\"co:VisitStatus=\"COMPLETE\"co:VisitName=\"ScreeningForm\"co:VisitStartDate=\"2025-10-29T00:00:00.000Z\">\n\t\t\t\t<AuditRecord>\n\t\t\t\t\t<UserRefUserOID=\"testuser3\">\n\t\t\t\t\t</UserRef>\n\t\t\t\t\t<LocationRefLocationOID=\"DATAHUB_AUT_Site2_Active\">\n\t\t\t\t\t</LocationRef>\n\t\t\t\t\t<DateTimeStamp>2025-10-29T13:31:11.372Z</DateTimeStamp>\n\t\t\t\t</AuditRecord>\n\t\t\t</StudyEventData>\n\t\t</SubjectData>\n\t</ClinicalData>\n\t<ClinicalDataStudyOID=\"STUDY01\"MetaDataVersionOID=\"1.0.0.2\"co:StudyID=\"0C7CBA3F70034C47947E2FAB086BFBF5\"co:StudyVersionStart=\"2025-10-29T13:01:17.592Z\">\n\t\t<SubjectDataSubjectKey=\"DATAHUB_AUT_Site2_Active01\"co:SubjectGUID=\"C6A18791060849BBBAE1F7A16A62B389\">\n\t\t\t<StudyEventDataStudyEventOID=\"Baseline_5DF278EB00F24820B9CEFE7BFD7A3078\"co:VisitGUID=\"5DF278EB00F24820B9CEFE7BFD7A3078\"co:VisitSequence=\"24\"co:VisitStatus=\"INPROGRESS\"co:VisitName=\"Baseline\"co:VisitStartDate=\"2025-10-29T00:00:00.000Z\">\n\t\t\t\t<AuditRecord>\n\t\t\t\t\t<UserRefUserOID=\"testuser3\">\n\t\t\t\t\t</UserRef>\n\t\t\t\t\t<LocationRefLocationOID=\"DATAHUB_AUT_Site2_Active\">\n\t\t\t\t\t</LocationRef>\n\t\t\t\t\t<DateTimeStamp>2025-10-29T13:43:28.354Z</DateTimeStamp>\n\t\t\t\t</AuditRecord>\n\t\t\t</StudyEventData>\n\t\t</SubjectData>\n\t</ClinicalData>\n\t<ClinicalDataStudyOID=\"STUDY01\"MetaDataVersionOID=\"1.0.0.2\"co:StudyID=\"0C7CBA3F70034C47947E2FAB086BFBF5\"co:StudyVersionStart=\"2025-10-29T13:01:17.592Z\">\n\t\t<SubjectDataSubjectKey=\"DATAHUB_AUT_Site2_Active01\"co:SubjectGUID=\"C6A18791060849BBBAE1F7A16A62B389\">\n\t\t\t<StudyEventDataStudyEventOID=\"Week1_3279AFB1AA3C44CFB6D6C419AAAC8A84\"co:VisitGUID=\"3279AFB1AA3C44CFB6D6C419AAAC8A84\"co:VisitSequence=\"360\"co:VisitStatus=\"NEW\"co:VisitName=\"Week1\">\n\t\t\t\t<AuditRecord>\n\t\t\t\t\t<UserRefUserOID=\"testuser3\">\n\t\t\t\t\t</UserRef>\n\t\t\t\t\t<LocationRefLocationOID=\"DATAHUB_AUT_Site2_Active\">\n\t\t\t\t\t</LocationRef>\n\t\t\t\t\t<DateTimeStamp>2025-10-29T13:50:50.244Z</DateTimeStamp>\n\t\t\t\t</AuditRecord>\n\t\t\t</StudyEventData>\n\t\t</SubjectData>\n\t</ClinicalData>\n\t<ClinicalDataStudyOID=\"STUDY01\"MetaDataVersionOID=\"1.0.0.2\"co:StudyID=\"0C7CBA3F70034C47947E2FAB086BFBF5\"co:StudyVersionStart=\"2025-10-29T13:01:17.592Z\">\n\t\t<SubjectDataSubjectKey=\"DATAHUB_AUT_Site2_Active01\"co:SubjectGUID=\"C6A18791060849BBBAE1F7A16A62B389\">\n\t\t\t<SiteRefLocationOID=\"DATAHUB_AUT_Site2_Active\"co:Country=\"US\">\n\t\t\t</SiteRef>\n\t\t\t<StudyEventDataStudyEventOID=\"SCR_FD227430BECA4DECA5EA8B0E4DBE18CA\"co:VisitGUID=\"FD227430BECA4DECA5EA8B0E4DBE18CA\"co:VisitSequence=\"0\"co:VisitName=\"ScreeningForm\">\n\t\t\t\t<FormDataFormOID=\"FORM_02_FC21BE51B8424A54907F2F3672E72C29\"co:FormGUID=\"FC21BE51B8424A54907F2F3672E72C29\"co:FormStatus=\"COMPLETED\">\n\t\t\t\t\t<ItemGroupDataItemGroupOID=\"SUBJECT_INITIALS_CF149710CBE24A6BB9266E52B5F5BA0F\"co:ItemGroupGUID=\"CF149710CBE24A6BB9266E52B5F5BA0F\">\n\t\t\t\t\t\t<ItemDataItemOID=\"SUBJECT_INITIALS_CF149710CBE24A6BB9266E52B5F5BA0F\"TransactionType=\"Upsert\"Value=\"ABC\"co:ItemGUID=\"CF149710CBE24A6BB9266E52B5F5BA0F\"co:DecodedValue=\"ABC\"co:ValidationStatus=\"SUCCESS\"co:SDVSelectionStatus=\"OBLIGATORY\">\n\t\t\t\t\t\t\t<AuditRecord>\n\t\t\t\t\t\t\t\t<UserRefUserOID=\"testuser3\">\n\t\t\t\t\t\t\t\t</UserRef>\n\t\t\t\t\t\t\t\t<LocationRefLocationOID=\"DATAHUB_AUT_Site2_Active\">\n\t\t\t\t\t\t\t\t</LocationRef>\n\t\t\t\t\t\t\t\t<DateTimeStamp>2025-10-29T13:30:09.355Z</DateTimeStamp>\n\t\t\t\t\t\t\t</AuditRecord>\n\t\t\t\t\t\t</ItemData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day\"co:ValidationStatus=\"SUCCESS\"co:SDVSelectionStatus=\"OBLIGATORY\">\n\t\t\t\t\t\t\t<AuditRecord>\n\t\t\t\t\t\t\t\t<UserRefUserOID=\"testuser3\">\n\t\t\t\t\t\t\t\t</UserRef>\n\t\t\t\t\t\t\t\t<LocationRefLocationOID=\"DATAHUB_AUT_Site2_Active\">\n\t\t\t\t\t\t\t\t</LocationRef>\n\t\t\t\t\t\t\t\t<DateTimeStamp>2025-10-29T13:43:29.773Z</DateTimeStamp>\n\t\t\t\t\t\t\t</AuditRecord>\n\t\t\t\t\t\t</ItemData>\n\t\t\t\t\t</ItemGroupData>\n\t\t\t\t</FormData>\n\t\t\t</StudyEventData>\n\t\t</SubjectData>\n\t</ClinicalData>\n\t<ClinicalDataStudyOID=\"STUDY01\"MetaDataVersionOID=\"1.0.0.2\"co:StudyID=\"0C7CBA3F70034C47947E2FAB086BFBF5\"co:StudyVersionStart=\"2025-10-29T13:01:17.592Z\">\n\t\t<SubjectDataSubjectKey=\"DATAHUB_AUT_Site2_Active01\"co:SubjectGUID=\"C6A18791060849BBBAE1F7A16A62B389\">\n\t\t\t<SiteRefLocationOID=\"DATAHUB_AUT_Site2_Active\"co:Country=\"US\">\n\t\t\t</SiteRef>\n\t\t\t<StudyEventDataStudyEventOID=\"Baseline_5DF278EB00F24820B9CEFE7BFD7A3078\"co:VisitGUID=\"5DF278EB00F24820B9CEFE7BFD7A3078\"co:VisitSequence=\"24\"co:VisitName=\"Baseline\">\n\t\t\t\t<FormDataFormOID=\"CONCOMITANT_MEDICATIONS_FORM_234478166C0D4394BA6FF6E4378D6AEF\"FormRepeatKey=\"1\"co:FormGUID=\"234478166C0D4394BA6FF6E4378D6AEF\"co:FormStatus=\"COMPLETED\"co:OuterRepeat=\"1\">\n\t\t\t\t\t<ItemGroupDataItemGroupOID=\"START_DATE_MEDICATION_9ABA8F3316FA4D6CAD019CF99A3B28CA\"co:ItemGroupGUID=\"9ABA8F3316FA4D6CAD019CF99A3B28CA\">\n\t\t\t\t\t\t<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\">\n\t\t\t\t\t\t\t<AuditRecord>\n\t\t\t\t\t\t\t\t<UserRefUserOID=\"testuser3\">\n\t\t\t\t\t\t\t\t</UserRef>\n\t\t\t\t\t\t\t\t<LocationRefLocationOID=\"DATAHUB_AUT_Site2_Active\">\n\t\t\t\t\t\t\t\t</LocationRef>\n\t\t\t\t\t\t\t\t<DateTimeStamp>2025-10-29T13:43:29.779Z</DateTimeStamp>\n\t\t\t\t\t\t\t</AuditRecord>\n\t\t\t\t\t\t</ItemData>\n\t\t\t\t\t</ItemGroupData>\n\t\t\t\t</FormData>\n\t\t\t</StudyEventData>\n\t\t</SubjectData>\n\t</ClinicalData>\n\t<ClinicalDataStudyOID=\"STUDY01\"MetaDataVersionOID=\"1.0.0.2\"co:StudyID=\"0C7CBA3F70034C47947E2FAB086BFBF5\"co:StudyVersionStart=\"2025-10-29T13:01:17.592Z\">\n\t\t<SubjectDataSubjectKey=\"DATAHUB_AUT_Site2_Active01\"co:SubjectGUID=\"C6A18791060849BBBAE1F7A16A62B389\">\n\t\t\t<SiteRefLocationOID=\"DATAHUB_AUT_Site2_Active\"co:Country=\"US\">\n\t\t\t</SiteRef>\n\t\t\t<StudyEventDataStudyEventOID=\"Baseline_5DF278EB00F24820B9CEFE7BFD7A3078\"co:VisitGUID=\"5DF278EB00F24820B9CEFE7BFD7A3078\"co:VisitSequence=\"24\"co:VisitName=\"Baseline\">\n\t\t\t\t<FormDataFormOID=\"CONCOMITANT_MEDICATIONS_FORM_234478166C0D4394BA6FF6E4378D6AEF\"FormRepeatKey=\"1\"co:FormGUID=\"234478166C0D4394BA6FF6E4378D6AEF\"co:FormStatus=\"COMPLETED\"co:OuterRepeat=\"1\">\n\t\t\t\t\t<ItemGroupDataItemGroupOID=\"STOP_DATE_MEDICATION_16C802F711504BED96EFF2198AD02A34\"co:ItemGroupGUID=\"16C802F711504BED96EFF2198AD02A34\">\n\t\t\t\t\t\t<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\">\n\t\t\t\t\t\t\t<AuditRecord>\n\t\t\t\t\t\t\t\t<UserRefUserOID=\"testuser3\">\n\t\t\t\t\t\t\t\t</UserRef>\n\t\t\t\t\t\t\t\t<LocationRefLocationOID=\"DATAHUB_AUT_Site2_Active\">\n\t\t\t\t\t\t\t\t</LocationRef>\n\t\t\t\t\t\t\t\t<DateTimeStamp>2025-10-29T13:43:29.785Z</DateTimeStamp>\n\t\t\t\t\t\t\t</AuditRecord>\n\t\t\t\t\t\t</ItemData>\n\t\t\t\t\t</ItemGroupData>\n\t\t\t\t</FormData>\n\t\t\t</StudyEventData>\n\t\t</SubjectData>\n\t</ClinicalData>\n\t<ClinicalDataStudyOID=\"STUDY01\"MetaDataVersionOID=\"1.0.0.2\"co:StudyID=\"0C7CBA3F70034C47947E2FAB086BFBF5\"co:StudyVersionStart=\"2025-10-29T13:01:17.592Z\">\n\t\t<SubjectDataSubjectKey=\"DATAHUB_AUT_Site2_Active01\"co:SubjectGUID=\"C6A18791060849BBBAE1F7A16A62B389\">\n\t\t\t<SiteRefLocationOID=\"DATAHUB_AUT_Site2_Active\"co:Country=\"US\">\n\t\t\t</SiteRef>\n\t\t\t<StudyEventDataStudyEventOID=\"Baseline_5DF278EB00F24820B9CEFE7BFD7A3078\"co:VisitGUID=\"5DF278EB00F24820B9CEFE7BFD7A3078\"co:VisitSequence=\"24\"co:VisitName=\"Baseline\">\n\t\t\t\t<FormDataFormOID=\"DEMOG_3DC0796D51654FEBA0F1ED98EBE8A73B\"co:FormGUID=\"3DC0796D51654FEBA0F1ED98EBE8A73B\"co:FormStatus=\"COMPLETED\">\n\t\t\t\t\t<ItemGroupDataItemGroupOID=\"GENDER_1A4A881F48114F51A7247CEBE773C521\"co:ItemGroupGUID=\"1A4A881F48114F51A7247CEBE773C521\">\n\t\t\t\t\t\t<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\">\n\t\t\t\t\t\t\t<AuditRecord>\n\t\t\t\t\t\t\t\t<UserRefUserOID=\"testuser3\">\n\t\t\t\t\t\t\t\t</UserRef>\n\t\t\t\t\t\t\t\t<LocationRefLocationOID=\"DATAHUB_AUT_Site2_Active\">\n\t\t\t\t\t\t\t\t</LocationRef>\n\t\t\t\t\t\t\t\t<DateTimeStamp>2025-10-29T13:43:39.046Z</DateTimeStamp>\n\t\t\t\t\t\t\t\t<ReasonForChange>TranscriptionError</ReasonForChange>\n\t\t\t\t\t\t\t</AuditRecord>\n\t\t\t\t\t\t</ItemData>\n\t\t\t\t\t</ItemGroupData>\n\t\t\t\t</FormData>\n\t\t\t</StudyEventData>\n\t\t</SubjectData>\n\t</ClinicalData>\n</ODM>",
    "xml":{
        "name":"ODM"
    }
}

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">
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								<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

• annotations: array Annotations
• auditRecords: array AuditRecords
• metaDataVersionOID: string
• signatures: array Signatures
• studyOID: string
• subjectData: array subjectData

{
    "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"
    }
}

Nested Schema : Annotations

Type: array

Show Source

• Array of: object Annotations

{
    "type":"array",
    "xml":{
        "name":"Annotations"
    },
    "items":{
        "$ref":"#/components/schemas/Annotations"
    }
}

Nested Schema : AuditRecords

Type: array

Show Source

• Array of: object AuditRecords

{
    "type":"array",
    "xml":{
        "name":"AuditRecords"
    },
    "items":{
        "$ref":"#/components/schemas/AuditRecords"
    }
}

Nested Schema : Signatures

Type: array

Show Source

• Array of: object Signatures

{
    "type":"array",
    "xml":{
        "name":"Signatures"
    },
    "items":{
        "$ref":"#/components/schemas/Signatures"
    }
}

Nested Schema : subjectData

Type: array

Show Source

• Array of: object SubjectData

{
    "type":"array",
    "items":{
        "$ref":"#/components/schemas/SubjectData"
    }
}

Nested Schema : Annotations

Type: object

Show Source

• annotation: array Annotation

{
    "type":"object",
    "properties":{
        "annotation":{
            "type":"array",
            "xml":{
                "name":"Annotation"
            },
            "items":{
                "$ref":"#/components/schemas/Annotation"
            }
        }
    }
}

Nested Schema : Annotation

Type: array

Show Source

• Array of: object Annotation

{
    "type":"array",
    "xml":{
        "name":"Annotation"
    },
    "items":{
        "$ref":"#/components/schemas/Annotation"
    }
}

Nested Schema : Annotation

Type: object

Show Source

• comment: object Comment
• flag: array Flag
• id: string
• seqNum: integer
• transactionType: string
  Allowed Values: [ "INSERT", "UPDATE", "REMOVE", "UPSERT", "CONTEXT" ]

{
    "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"
    }
}

Nested Schema : Comment

Type: object

Show Source

• sponsorOrSite: string
  Allowed Values: [ "SPONSOR", "SITE" ]
• value: string

{
    "type":"object",
    "properties":{
        "value":{
            "type":"string"
        },
        "sponsorOrSite":{
            "type":"string",
            "xml":{
                "name":"SponsorOrSite",
                "attribute":true
            },
            "enum":[
                "SPONSOR",
                "SITE"
            ]
        }
    }
}

Nested Schema : Flag

Type: array

Show Source

• Array of: object Flag

{
    "type":"array",
    "xml":{
        "name":"Flag"
    },
    "items":{
        "$ref":"#/components/schemas/Flag"
    }
}

Nested Schema : Flag

Type: object

Show Source

• flagType: object FlagType
• flagValue(required): object FlagValue

{
    "required":[
        "flagValue"
    ],
    "type":"object",
    "properties":{
        "flagValue":{
            "$ref":"#/components/schemas/FlagValue"
        },
        "flagType":{
            "$ref":"#/components/schemas/FlagType"
        }
    }
}

Nested Schema : FlagType

Type: object

Show Source

• codeListOID: string
• value: string

{
    "type":"object",
    "properties":{
        "value":{
            "type":"string"
        },
        "codeListOID":{
            "type":"string",
            "xml":{
                "name":"CodeListOID",
                "attribute":true
            }
        }
    }
}

Nested Schema : FlagValue

Type: object

Show Source

• codeListOID: string
• value: string

{
    "type":"object",
    "properties":{
        "value":{
            "type":"string"
        },
        "codeListOID":{
            "type":"string",
            "xml":{
                "name":"CodeListOID",
                "attribute":true
            }
        }
    }
}

Nested Schema : AuditRecords

Type: object

Show Source

• auditRecord: array AuditRecord

{
    "type":"object",
    "properties":{
        "auditRecord":{
            "type":"array",
            "xml":{
                "name":"AuditRecord"
            },
            "items":{
                "$ref":"#/components/schemas/AuditRecord"
            }
        }
    }
}

Nested Schema : AuditRecord

Type: array

Show Source

• Array of: object AuditRecord

{
    "type":"array",
    "xml":{
        "name":"AuditRecord"
    },
    "items":{
        "$ref":"#/components/schemas/AuditRecord"
    }
}

Nested Schema : AuditRecord

Type: object

Show Source

• 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", "Yes", "No" ]

  Represents a Yes or No value.

  Example: Yes
• userRef(required): object UserRef

{
    "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
            }
        }
    }
}

Nested Schema : DateTimeStamp

Type: object

Show Source

• value: string (date-time)

{
    "type":"object",
    "properties":{
        "value":{
            "type":"string",
            "format":"date-time"
        }
    }
}

Nested Schema : LocationRef

Type: object

Show Source

• locationOID: string

{
    "type":"object",
    "properties":{
        "locationOID":{
            "type":"string",
            "xml":{
                "name":"LocationOID",
                "attribute":true
            }
        }
    }
}

Nested Schema : ReasonForChange

Type: object

Show Source

• value: string

{
    "type":"object",
    "properties":{
        "value":{
            "type":"string"
        }
    },
    "xml":{
        "name":"ReasonForChange",
        "namespace":"http://www.cdisc.org/ns/odm/v1.3"
    }
}

Nested Schema : SourceID

Type: object

Show Source

• value: string

{
    "type":"object",
    "properties":{
        "value":{
            "type":"string"
        }
    }
}

Nested Schema : UserRef

Type: object

Show Source

• userOID: string

{
    "type":"object",
    "properties":{
        "userOID":{
            "type":"string",
            "xml":{
                "name":"UserOID",
                "attribute":true
            }
        }
    }
}

Nested Schema : Signatures

Type: object

Show Source

• signature: array Signature

{
    "type":"object",
    "properties":{
        "signature":{
            "type":"array",
            "xml":{
                "name":"Signature"
            },
            "items":{
                "$ref":"#/components/schemas/Signature"
            }
        }
    }
}

Nested Schema : Signature

Type: array

Show Source

• Array of: object Signature

{
    "type":"array",
    "xml":{
        "name":"Signature"
    },
    "items":{
        "$ref":"#/components/schemas/Signature"
    }
}

Nested Schema : Signature

Type: object

Show Source

• cryptoBindingManifest: object CryptoBindingManifest
• dateTimeStamp(required): object DateTimeStamp
• id: string
• locationRef(required): object LocationRef
• signatureRef(required): object SignatureRef
• userRef(required): object UserRef

{
    "required":[
        "dateTimeStamp",
        "locationRef",
        "signatureRef",
        "userRef"
    ],
    "type":"object",
    "properties":{
        "userRef":{
            "$ref":"#/components/schemas/UserRef"
        },
        "locationRef":{
            "$ref":"#/components/schemas/LocationRef"
        },
        "signatureRef":{
            "$ref":"#/components/schemas/SignatureRef"
        },
        "dateTimeStamp":{
            "$ref":"#/components/schemas/DateTimeStamp"
        },
        "cryptoBindingManifest":{
            "$ref":"#/components/schemas/CryptoBindingManifest"
        },
        "id":{
            "type":"string",
            "xml":{
                "name":"ID",
                "attribute":true
            }
        }
    }
}

Nested Schema : CryptoBindingManifest

Type: object

Show Source

• value: string

{
    "type":"object",
    "properties":{
        "value":{
            "type":"string"
        }
    }
}

Nested Schema : SignatureRef

Type: object

Show Source

• signatureOID: string

{
    "type":"object",
    "properties":{
        "signatureOID":{
            "type":"string",
            "xml":{
                "name":"SignatureOID",
                "attribute":true
            }
        }
    }
}

Nested Schema : SubjectData

Type: object

Show Source

• 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" ]

{
    "type":"object",
    "properties":{
        "auditRecord":{
            "$ref":"#/components/schemas/AuditRecord"
        },
        "signature":{
            "$ref":"#/components/schemas/Signature"
        },
        "investigatorRef":{
            "$ref":"#/components/schemas/InvestigatorRef"
        },
        "siteRef":{
            "$ref":"#/components/schemas/SiteRef"
        },
        "annotation":{
            "type":"array",
            "xml":{
                "name":"Annotation"
            },
            "items":{
                "$ref":"#/components/schemas/Annotation"
            }
        },
        "studyEventData":{
            "type":"array",
            "items":{
                "$ref":"#/components/schemas/StudyEventData"
            }
        },
        "subjectKey":{
            "type":"string",
            "xml":{
                "name":"SubjectKey",
                "attribute":true
            }
        },
        "transactionType":{
            "type":"string",
            "xml":{
                "name":"TransactionType",
                "attribute":true
            },
            "enum":[
                "INSERT",
                "UPDATE",
                "REMOVE",
                "UPSERT",
                "CONTEXT"
            ]
        }
    },
    "xml":{
        "name":"SubjectData",
        "namespace":"http://www.cdisc.org/ns/odm/v1.3"
    }
}

Nested Schema : Annotation

Type: array

Show Source

• Array of: object Annotation

{
    "type":"array",
    "xml":{
        "name":"Annotation"
    },
    "items":{
        "$ref":"#/components/schemas/Annotation"
    }
}

Nested Schema : InvestigatorRef

Type: object

Show Source

• userOID: string

{
    "type":"object",
    "properties":{
        "userOID":{
            "type":"string",
            "xml":{
                "name":"UserOID",
                "attribute":true
            }
        }
    }
}

Nested Schema : SiteRef

Type: object

Show Source

• locationOID: string

{
    "type":"object",
    "properties":{
        "locationOID":{
            "type":"string",
            "xml":{
                "name":"LocationOID",
                "attribute":true
            }
        }
    },
    "xml":{
        "name":"SiteRef",
        "namespace":"http://www.cdisc.org/ns/odm/v1.3"
    }
}

Nested Schema : studyEventData

Type: array

Show Source

• Array of: object StudyEventData

{
    "type":"array",
    "items":{
        "$ref":"#/components/schemas/StudyEventData"
    }
}

Nested Schema : StudyEventData

Type: object

Show Source

• 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" ]

{
    "type":"object",
    "properties":{
        "auditRecord":{
            "$ref":"#/components/schemas/AuditRecord"
        },
        "signature":{
            "$ref":"#/components/schemas/Signature"
        },
        "annotation":{
            "type":"array",
            "xml":{
                "name":"Annotation"
            },
            "items":{
                "$ref":"#/components/schemas/Annotation"
            }
        },
        "formData":{
            "type":"array",
            "items":{
                "$ref":"#/components/schemas/FormData"
            }
        },
        "studyEventOID":{
            "type":"string",
            "xml":{
                "name":"StudyEventOID",
                "attribute":true
            }
        },
        "studyEventRepeatKey":{
            "type":"string",
            "xml":{
                "name":"StudyEventRepeatKey",
                "attribute":true
            }
        },
        "transactionType":{
            "type":"string",
            "xml":{
                "name":"TransactionType",
                "attribute":true
            },
            "enum":[
                "INSERT",
                "UPDATE",
                "REMOVE",
                "UPSERT",
                "CONTEXT"
            ]
        }
    },
    "xml":{
        "name":"StudyEventData",
        "namespace":"http://www.cdisc.org/ns/odm/v1.3"
    }
}

Nested Schema : Annotation

Type: array

Show Source

• Array of: object Annotation

{
    "type":"array",
    "xml":{
        "name":"Annotation"
    },
    "items":{
        "$ref":"#/components/schemas/Annotation"
    }
}

Nested Schema : formData

Type: array

Show Source

• Array of: object FormData

{
    "type":"array",
    "items":{
        "$ref":"#/components/schemas/FormData"
    }
}

Nested Schema : FormData

Type: object

Show Source

• 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" ]

{
    "type":"object",
    "properties":{
        "auditRecord":{
            "$ref":"#/components/schemas/AuditRecord"
        },
        "signature":{
            "$ref":"#/components/schemas/Signature"
        },
        "archiveLayoutRef":{
            "$ref":"#/components/schemas/ArchiveLayoutRef"
        },
        "annotation":{
            "type":"array",
            "xml":{
                "name":"Annotation"
            },
            "items":{
                "$ref":"#/components/schemas/Annotation"
            }
        },
        "itemGroupData":{
            "type":"array",
            "items":{
                "$ref":"#/components/schemas/ItemGroupData"
            }
        },
        "formOID":{
            "type":"string",
            "xml":{
                "name":"FormOID",
                "attribute":true
            }
        },
        "formRepeatKey":{
            "type":"string",
            "xml":{
                "name":"FormRepeatKey",
                "attribute":true
            }
        },
        "transactionType":{
            "type":"string",
            "xml":{
                "name":"TransactionType",
                "attribute":true
            },
            "enum":[
                "INSERT",
                "UPDATE",
                "REMOVE",
                "UPSERT",
                "CONTEXT"
            ]
        }
    },
    "xml":{
        "name":"FormData",
        "namespace":"http://www.cdisc.org/ns/odm/v1.3"
    }
}

Nested Schema : Annotation

Type: array

Show Source

• Array of: object Annotation

{
    "type":"array",
    "xml":{
        "name":"Annotation"
    },
    "items":{
        "$ref":"#/components/schemas/Annotation"
    }
}

Nested Schema : ArchiveLayoutRef

Type: object

Show Source

• archiveLayoutOID: string

{
    "type":"object",
    "properties":{
        "archiveLayoutOID":{
            "type":"string",
            "xml":{
                "name":"ArchiveLayoutOID",
                "attribute":true
            }
        }
    }
}

Nested Schema : itemGroupData

Type: array

Show Source

• Array of: object ItemGroupData

{
    "type":"array",
    "items":{
        "$ref":"#/components/schemas/ItemGroupData"
    }
}

Nested Schema : ItemGroupData

Type: object

Show Source

• 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" ]

{
    "type":"object",
    "properties":{
        "auditRecord":{
            "$ref":"#/components/schemas/AuditRecord"
        },
        "signature":{
            "$ref":"#/components/schemas/Signature"
        },
        "annotation":{
            "type":"array",
            "xml":{
                "name":"Annotation"
            },
            "items":{
                "$ref":"#/components/schemas/Annotation"
            }
        },
        "itemDataGroup":{
            "type":"array",
            "items":{
                "$ref":"#/components/schemas/ItemData"
            }
        },
        "itemDataStarGroup":{
            "type":"array",
            "items":{
                "type":"object"
            }
        },
        "itemGroupOID":{
            "type":"string",
            "xml":{
                "name":"ItemGroupOID",
                "attribute":true
            }
        },
        "itemGroupRepeatKey":{
            "type":"string",
            "xml":{
                "name":"ItemGroupRepeatKey",
                "attribute":true
            }
        },
        "transactionType":{
            "type":"string",
            "xml":{
                "name":"TransactionType",
                "attribute":true
            },
            "enum":[
                "INSERT",
                "UPDATE",
                "REMOVE",
                "UPSERT",
                "CONTEXT"
            ]
        }
    },
    "xml":{
        "name":"ItemGroupData",
        "namespace":"http://www.cdisc.org/ns/odm/v1.3"
    }
}

Nested Schema : Annotation

Type: array

Show Source

• Array of: object Annotation

{
    "type":"array",
    "xml":{
        "name":"Annotation"
    },
    "items":{
        "$ref":"#/components/schemas/Annotation"
    }
}

Nested Schema : itemDataGroup

Type: array

Show Source

• Array of: object ItemData

{
    "type":"array",
    "items":{
        "$ref":"#/components/schemas/ItemData"
    }
}

Nested Schema : itemDataStarGroup

Type: array

Show Source

• Array of: object items

{
    "type":"array",
    "items":{
        "type":"object"
    }
}

Nested Schema : ItemData

Type: object

Show Source

• 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

{
    "type":"object",
    "properties":{
        "auditRecord":{
            "$ref":"#/components/schemas/AuditRecord"
        },
        "signature":{
            "$ref":"#/components/schemas/Signature"
        },
        "measurementUnitRef":{
            "$ref":"#/components/schemas/MeasurementUnitRef"
        },
        "annotation":{
            "type":"array",
            "xml":{
                "name":"Annotation"
            },
            "items":{
                "$ref":"#/components/schemas/Annotation"
            }
        },
        "itemOID":{
            "type":"string",
            "xml":{
                "name":"ItemOID",
                "attribute":true
            }
        },
        "transactionType":{
            "type":"string",
            "xml":{
                "name":"TransactionType",
                "attribute":true
            },
            "enum":[
                "INSERT",
                "UPDATE",
                "REMOVE",
                "UPSERT",
                "CONTEXT"
            ]
        },
        "isNull":{
            "type":"string",
            "xml":{
                "name":"IsNull",
                "attribute":true
            },
            "enum":[
                "YES"
            ]
        },
        "value":{
            "type":"string",
            "xml":{
                "name":"Value",
                "attribute":true
            }
        }
    },
    "xml":{
        "name":"ItemData",
        "namespace":"http://www.cdisc.org/ns/odm/v1.3"
    }
}

Nested Schema : Annotation

Type: array

Show Source

• Array of: object Annotation

{
    "type":"array",
    "xml":{
        "name":"Annotation"
    },
    "items":{
        "$ref":"#/components/schemas/Annotation"
    }
}

Nested Schema : MeasurementUnitRef

Type: object

Show Source

• measurementUnitOID: string

{
    "type":"object",
    "properties":{
        "measurementUnitOID":{
            "type":"string",
            "xml":{
                "name":"MeasurementUnitOID",
                "attribute":true
            }
        }
    }
}

Nested Schema : items

Type: object

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

• errorData: object errorData
  Error details when status is error.
• result: object result
  Payload returned by the API when status is success.
• status: string
  Overall request processing status.

  Example: success
• version: integer (int32)
  Envelope version number.

  Example: 1

{
    "type":"object",
    "properties":{
        "status":{
            "type":"string",
            "description":"Overall request processing status.",
            "example":"success"
        },
        "result":{
            "type":"object",
            "description":"Payload returned by the API when status is success.",
            "example":{
                "message":"Operation succeeded"
            }
        },
        "errorData":{
            "type":"object",
            "description":"Error details when status is error.",
            "example":{
                "errorCode":"C1-003",
                "errorMessage":"Validation failed",
                "details":{
                    "field":"limit",
                    "message":"limit must be >= 1"
                }
            }
        },
        "version":{
            "type":"integer",
            "description":"Envelope version number.",
            "format":"int32",
            "example":1
        }
    },
    "description":"Standard response envelope containing status, optional result payload, optional error information and a version number."
}

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"
}

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