REST API for Clinical One Platform

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.

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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: A86F2D0BB610404DB62D37AFA9C20B50
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":"A86F2D0BB610404DB62D37AFA9C20B50",
            "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>\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=\"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=\"DATETIME_02_528E107E03E84E5EB7558F6696C05758\"co:ItemGroupGUID=\"528E107E03E84E5EB7558F6696C05758\">\n\t\t\t\t\t\t<ItemDataItemOID=\"DATETIME_02_528E107E03E84E5EB7558F6696C05758\"TransactionType=\"Upsert\"Value=\"09-Nov-2020 00:00\"co:ItemGUID=\"528E107E03E84E5EB7558F6696C05758\"co:DecodedValue=\"09-Nov-2020 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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",
            "items":{
                "$ref":"#/components/schemas/Annotation"
            }
        }
    }
}

Nested Schema : Annotation

Type: array

Show Source

Array of: object Annotation

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

Nested Schema : Annotation

Type: object

Show Source

Comment: object Comment

Annotation comment object
Flag: object Flag

Flags associated with this annotation
ID: string

Annotation identifier

Example: AN1
SeqNum: integer (int32)

Sequence number for annotation

Example: 1
TransactionType: string

Allowed Values: [ "INSERT", "UPDATE", "REMOVE", "UPSERT", "CONTEXT" ]

Transaction type for annotation

Example: INSERT

{
    "type":"object",
    "properties":{
        "Comment":{
            "$ref":"#/components/schemas/Comment"
        },
        "Flag":{
            "type":"object",
            "properties":{
                "FlagValue":{
                    "$ref":"#/components/schemas/FlagValue"
                },
                "FlagType":{
                    "$ref":"#/components/schemas/FlagType"
                }
            },
            "description":"Flags associated with this annotation",
            "example":[
                {
                    "flagOID":"FLAG1"
                }
            ]
        },
        "SeqNum":{
            "type":"integer",
            "description":"Sequence number for annotation",
            "format":"int32",
            "example":1
        },
        "TransactionType":{
            "type":"string",
            "description":"Transaction type for annotation",
            "example":"INSERT",
            "enum":[
                "INSERT",
                "UPDATE",
                "REMOVE",
                "UPSERT",
                "CONTEXT"
            ]
        },
        "ID":{
            "type":"string",
            "description":"Annotation identifier",
            "example":"AN1"
        }
    }
}

Nested Schema : Comment

Type: object

Annotation comment object

Show Source

SponsorOrSite: string

Allowed Values: [ "SPONSOR", "SITE" ]
Value: string

{
    "type":"object",
    "properties":{
        "Value":{
            "type":"string"
        },
        "SponsorOrSite":{
            "type":"string",
            "enum":[
                "SPONSOR",
                "SITE"
            ]
        }
    },
    "description":"Annotation comment object",
    "example":{
        "value":"Requires follow-up"
    }
}

Example:

{
    "value":"Requires follow-up"
}

Nested Schema : Flag

Type: object

Flags associated with this annotation

Show Source

FlagType: object FlagType
FlagValue: object FlagValue

{
    "type":"object",
    "properties":{
        "FlagValue":{
            "$ref":"#/components/schemas/FlagValue"
        },
        "FlagType":{
            "$ref":"#/components/schemas/FlagType"
        }
    },
    "description":"Flags associated with this annotation",
    "example":[
        {
            "flagOID":"FLAG1"
        }
    ]
}

Example:

[
    {
        "flagOID":"FLAG1"
    }
]

Nested Schema : FlagType

Type: object

Show Source

CodeListOID: string
Value: string

{
    "type":"object",
    "properties":{
        "Value":{
            "type":"string"
        },
        "CodeListOID":{
            "type":"string"
        }
    }
}

Nested Schema : FlagValue

Type: object

Show Source

CodeListOID: string
Value: string

{
    "type":"object",
    "properties":{
        "Value":{
            "type":"string"
        },
        "CodeListOID":{
            "type":"string"
        }
    }
}

Nested Schema : AuditRecords

Type: object

Show Source

AuditRecord: array AuditRecord

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

Nested Schema : AuditRecord

Type: array

Show Source

Array of: object AuditRecord

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

Nested Schema : AuditRecord

Type: object

Show Source

DateTimeStamp: object DateTimeStamp

Timestamp of signing
ID: string

Audit record identifier

Example: AUD1
LocationRef: object LocationRef

Reference to a study/site location for an ODM User.
ReasonForChange: object ReasonForChange

Reason for data change
SourceID: object SourceID

Source identifier
UserRef: object UserRef

Reference to user

{
    "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"
        },
        "ID":{
            "type":"string",
            "description":"Audit record identifier",
            "example":"AUD1"
        }
    }
}

Nested Schema : DateTimeStamp

Type: object

Timestamp of signing

Show Source

FormattedValue: string
Value: string

{
    "type":"object",
    "properties":{
        "Value":{
            "type":"string"
        },
        "FormattedValue":{
            "type":"string"
        }
    },
    "description":"Timestamp of signing",
    "example":{
        "value":"2025-10-27T10:00:00Z"
    }
}

Example:

{
    "value":"2025-10-27T10:00:00Z"
}

Nested Schema : LocationRef

Type: object

Reference to a study/site location for an ODM User.

Show Source

LocationOID: string

OID/ID for the associated location.

Example: LOC101

{
    "type":"object",
    "properties":{
        "LocationOID":{
            "type":"string",
            "description":"OID/ID for the associated location.",
            "example":"LOC101"
        }
    },
    "description":"Reference to a study/site location for an ODM User.",
    "example":{
        "locationOID":"LOC101"
    }
}

Example:

{
    "locationOID":"LOC101"
}

Nested Schema : ReasonForChange

Type: object

Reason for data change

Show Source

Value: string

{
    "type":"object",
    "properties":{
        "Value":{
            "type":"string"
        }
    },
    "description":"Reason for data change",
    "example":{
        "value":"Correction"
    }
}

Example:

{
    "value":"Correction"
}

Nested Schema : SourceID

Type: object

Source identifier

Show Source

Value: string

{
    "type":"object",
    "properties":{
        "Value":{
            "type":"string"
        }
    },
    "description":"Source identifier",
    "example":{
        "value":"SYS"
    }
}

Example:

{
    "value":"SYS"
}

Nested Schema : UserRef

Type: object

Reference to user

Show Source

UserOID: string

OID of the referenced user

Example: USER123

{
    "type":"object",
    "properties":{
        "UserOID":{
            "type":"string",
            "description":"OID of the referenced user",
            "example":"USER123"
        }
    },
    "description":"Reference to user",
    "example":{
        "userOID":"USER123"
    }
}

Example:

{
    "userOID":"USER123"
}

Nested Schema : Signatures

Type: object

Show Source

Signature: array Signature

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

Nested Schema : Signature

Type: array

Show Source

Array of: object Signature

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

Nested Schema : Signature

Type: object

Show Source

CryptoBindingManifest: object CryptoBindingManifest

Crypto binding manifest details
DateTimeStamp: object DateTimeStamp

Timestamp of signing
ID: string

Signature identifier

Example: SIG123
LocationRef: object LocationRef

Reference to a study/site location for an ODM User.
SignatureRef: object SignatureRef

Reference to signature
UserRef: object UserRef

Reference to user

{
    "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",
            "description":"Signature identifier",
            "example":"SIG123"
        }
    }
}

Nested Schema : CryptoBindingManifest

Type: object

Crypto binding manifest details

Show Source

Value: string

{
    "type":"object",
    "properties":{
        "Value":{
            "type":"string"
        }
    },
    "description":"Crypto binding manifest details",
    "example":{
        "manifestID":"CBM1"
    }
}

Example:

{
    "manifestID":"CBM1"
}

Nested Schema : SignatureRef

Type: object

Reference to signature

Show Source

SignatureOID: string

{
    "type":"object",
    "properties":{
        "SignatureOID":{
            "type":"string"
        }
    },
    "description":"Reference to signature",
    "example":{
        "refID":"SIGREF1"
    }
}

Example:

{
    "refID":"SIGREF1"
}

Nested Schema : SubjectData

Type: object

Show Source

Annotation: array Annotation
AuditRecord: object AuditRecord
Initials: string
InvestigatorRef: object InvestigatorRef
Signature: object Signature
SiteRef: object SiteRef
StudyEventData: array StudyEventData
SubjectHistory: array SubjectHistory
SubjectKey: string
TransactionType: string

Allowed Values: [ "INSERT", "UPDATE", "REMOVE", "UPSERT", "CONTEXT" ]
TransferData: array TransferData

{
    "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",
            "items":{
                "$ref":"#/components/schemas/Annotation"
            }
        },
        "StudyEventData":{
            "type":"array",
            "items":{
                "$ref":"#/components/schemas/StudyEventData"
            }
        },
        "SubjectKey":{
            "type":"string"
        },
        "TransactionType":{
            "type":"string",
            "enum":[
                "INSERT",
                "UPDATE",
                "REMOVE",
                "UPSERT",
                "CONTEXT"
            ]
        },
        "Initials":{
            "type":"string"
        },
        "TransferData":{
            "type":"array",
            "items":{
                "$ref":"#/components/schemas/TransferData"
            }
        },
        "SubjectHistory":{
            "type":"array",
            "items":{
                "$ref":"#/components/schemas/History"
            }
        }
    }
}

Nested Schema : Annotation

Type: array

Show Source

Array of: object Annotation

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

Nested Schema : InvestigatorRef

Type: object

Show Source

UserOID: string

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

Nested Schema : SiteRef

Type: object

Show Source

LocationOID: string
Name: string

{
    "type":"object",
    "properties":{
        "LocationOID":{
            "type":"string"
        },
        "Name":{
            "type":"string"
        }
    }
}

Nested Schema : StudyEventData

Type: array

Show Source

Array of: object StudyEventData

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

Nested Schema : SubjectHistory

Type: array

Show Source

Array of: object History

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

Nested Schema : TransferData

Type: array

Show Source

Array of: object TransferData

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

Nested Schema : StudyEventData

Type: object

Show Source

Annotation: array Annotation
AuditRecord: object AuditRecord
EventHistory: array EventHistory
FormData: array FormData
RepeatingFormSummary: object RepeatingFormSummary
Signature: object Signature
StudyEventOID: string
StudyEventRepeatKey: string

{
    "type":"object",
    "properties":{
        "AuditRecord":{
            "$ref":"#/components/schemas/AuditRecord"
        },
        "Signature":{
            "$ref":"#/components/schemas/Signature"
        },
        "Annotation":{
            "type":"array",
            "items":{
                "$ref":"#/components/schemas/Annotation"
            }
        },
        "FormData":{
            "type":"array",
            "items":{
                "$ref":"#/components/schemas/FormData"
            }
        },
        "StudyEventOID":{
            "type":"string"
        },
        "StudyEventRepeatKey":{
            "type":"string"
        },
        "RepeatingFormSummary":{
            "$ref":"#/components/schemas/RepeatingFormSummary"
        },
        "EventHistory":{
            "type":"array",
            "items":{
                "$ref":"#/components/schemas/History"
            }
        }
    }
}

Nested Schema : Annotation

Type: array

Show Source

Array of: object Annotation

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

Nested Schema : EventHistory

Type: array

Show Source

Array of: object History

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

Nested Schema : FormData

Type: array

Show Source

Array of: object FormData

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

Nested Schema : RepeatingFormSummary

Type: object

Show Source

RepeatingFormData: array RepeatingFormData

{
    "type":"object",
    "properties":{
        "RepeatingFormData":{
            "type":"array",
            "items":{
                "$ref":"#/components/schemas/RepeatingFormData"
            }
        }
    }
}

Nested Schema : History

Type: object

Show Source

action: string
actionDate: string (date-time)
details: array details

{
    "type":"object",
    "properties":{
        "action":{
            "type":"string"
        },
        "details":{
            "type":"array",
            "items":{
                "type":"string"
            }
        },
        "actionDate":{
            "type":"string",
            "format":"date-time"
        }
    }
}

Nested Schema : details

Type: array

Show Source

Array of: string

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

Nested Schema : FormData

Type: object

Show Source

Annotation: array Annotation
ArchiveLayoutRef: object ArchiveLayoutRef
AuditRecord: object AuditRecord
FormOID: string
FormRepeatKey: string
FormStatus: string
ItemGroupData: array ItemGroupData
NotDoneValue: string
Signature: object Signature
Signatures: object Signatures
Status: string
TitleAddendum: string
TransactionType: string

Allowed Values: [ "INSERT", "UPDATE", "REMOVE", "UPSERT", "CONTEXT" ]

{
    "type":"object",
    "properties":{
        "AuditRecord":{
            "$ref":"#/components/schemas/AuditRecord"
        },
        "Signature":{
            "$ref":"#/components/schemas/Signature"
        },
        "ArchiveLayoutRef":{
            "$ref":"#/components/schemas/ArchiveLayoutRef"
        },
        "Annotation":{
            "type":"array",
            "items":{
                "$ref":"#/components/schemas/Annotation"
            }
        },
        "ItemGroupData":{
            "type":"array",
            "items":{
                "$ref":"#/components/schemas/ItemGroupData"
            }
        },
        "FormOID":{
            "type":"string"
        },
        "FormRepeatKey":{
            "type":"string"
        },
        "TransactionType":{
            "type":"string",
            "enum":[
                "INSERT",
                "UPDATE",
                "REMOVE",
                "UPSERT",
                "CONTEXT"
            ]
        },
        "Status":{
            "type":"string"
        },
        "TitleAddendum":{
            "type":"string"
        },
        "FormStatus":{
            "type":"string"
        },
        "NotDoneValue":{
            "type":"string"
        },
        "Signatures":{
            "$ref":"#/components/schemas/Signatures"
        }
    }
}

Nested Schema : Annotation

Type: array

Show Source

Array of: object Annotation

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

Nested Schema : ArchiveLayoutRef

Type: object

Show Source

ArchiveLayoutOID: string

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

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: object Annotation

Annotations for the item group
AuditRecord: object AuditRecord
ItemGroupOID: string

OID for this item group

Example: IG1
ItemGroupRepeatKey: string

Repeat key for this group

Example: RPT1
Items: object Items

Contained item data list
Signature: object Signature
TransactionType: string

Allowed Values: [ "INSERT", "UPDATE", "REMOVE", "UPSERT", "CONTEXT" ]

Transaction type for the group

Example: INSERT

{
    "type":"object",
    "properties":{
        "AuditRecord":{
            "$ref":"#/components/schemas/AuditRecord"
        },
        "Signature":{
            "$ref":"#/components/schemas/Signature"
        },
        "Annotation":{
            "type":"object",
            "properties":{
                "Comment":{
                    "$ref":"#/components/schemas/Comment"
                },
                "Flag":{
                    "type":"object",
                    "properties":{
                        "FlagValue":{
                            "$ref":"#/components/schemas/FlagValue"
                        },
                        "FlagType":{
                            "$ref":"#/components/schemas/FlagType"
                        }
                    },
                    "description":"Flags associated with this annotation",
                    "example":[
                        {
                            "flagOID":"FLAG1"
                        }
                    ]
                },
                "SeqNum":{
                    "type":"integer",
                    "description":"Sequence number for annotation",
                    "format":"int32",
                    "example":1
                },
                "TransactionType":{
                    "type":"string",
                    "description":"Transaction type for annotation",
                    "example":"INSERT",
                    "enum":[
                        "INSERT",
                        "UPDATE",
                        "REMOVE",
                        "UPSERT",
                        "CONTEXT"
                    ]
                },
                "ID":{
                    "type":"string",
                    "description":"Annotation identifier",
                    "example":"AN1"
                }
            },
            "description":"Annotations for the item group",
            "example":[
                {
                    "annotationOID":"AN1"
                }
            ]
        },
        "Items":{
            "type":"object",
            "properties":{
                "AuditRecord":{
                    "$ref":"#/components/schemas/AuditRecord"
                },
                "Signature":{
                    "$ref":"#/components/schemas/Signature"
                },
                "MeasurementUnitRef":{
                    "$ref":"#/components/schemas/MeasurementUnitRef"
                },
                "Annotation":{
                    "type":"object",
                    "properties":{
                        "Comment":{
                            "$ref":"#/components/schemas/Comment"
                        },
                        "Flag":{
                            "type":"object",
                            "properties":{
                                "FlagValue":{
                                    "$ref":"#/components/schemas/FlagValue"
                                },
                                "FlagType":{
                                    "$ref":"#/components/schemas/FlagType"
                                }
                            },
                            "description":"Flags associated with this annotation",
                            "example":[
                                {
                                    "flagOID":"FLAG1"
                                }
                            ]
                        },
                        "SeqNum":{
                            "type":"integer",
                            "description":"Sequence number for annotation",
                            "format":"int32",
                            "example":1
                        },
                        "TransactionType":{
                            "type":"string",
                            "description":"Transaction type for annotation",
                            "example":"INSERT",
                            "enum":[
                                "INSERT",
                                "UPDATE",
                                "REMOVE",
                                "UPSERT",
                                "CONTEXT"
                            ]
                        },
                        "ID":{
                            "type":"string",
                            "description":"Annotation identifier",
                            "example":"AN1"
                        }
                    },
                    "description":"Annotations for this item",
                    "example":[
                        {
                            "id":"AN1"
                        }
                    ]
                },
                "ItemOID":{
                    "type":"string",
                    "description":"OID of the item",
                    "example":"ITM1"
                },
                "TransactionType":{
                    "type":"string",
                    "description":"Transaction type",
                    "example":"UPDATE",
                    "enum":[
                        "INSERT",
                        "UPDATE",
                        "REMOVE",
                        "UPSERT",
                        "CONTEXT"
                    ]
                },
                "ParentItemOID":{
                    "type":"string",
                    "description":"OID of parent item",
                    "example":"ITM_PARENT"
                },
                "NotDone":{
                    "type":"string",
                    "description":"Whether item is not done (0 or 1)",
                    "example":"0"
                },
                "SelectedCodeListItemsType":{
                    "type":"string",
                    "description":"Selected code list items type",
                    "example":"CODE_A"
                },
                "Value":{
                    "type":"string",
                    "description":"Value for this item",
                    "example":"130"
                },
                "DocumentId":{
                    "type":"string",
                    "description":"Document ID reference",
                    "example":"DOC1"
                },
                "DocumentVersion":{
                    "type":"number",
                    "description":"Document version",
                    "example":1
                }
            },
            "description":"Contained item data list",
            "example":[
                {
                    "itemOID":"ITM1"
                }
            ]
        },
        "ItemGroupOID":{
            "type":"string",
            "description":"OID for this item group",
            "example":"IG1"
        },
        "ItemGroupRepeatKey":{
            "type":"string",
            "description":"Repeat key for this group",
            "example":"RPT1"
        },
        "TransactionType":{
            "type":"string",
            "description":"Transaction type for the group",
            "example":"INSERT",
            "enum":[
                "INSERT",
                "UPDATE",
                "REMOVE",
                "UPSERT",
                "CONTEXT"
            ]
        }
    }
}

Nested Schema : Annotation

Type: object

Annotations for the item group

Show Source

Comment: object Comment

Annotation comment object
Flag: object Flag

Flags associated with this annotation
ID: string

Annotation identifier

Example: AN1
SeqNum: integer (int32)

Sequence number for annotation

Example: 1
TransactionType: string

Allowed Values: [ "INSERT", "UPDATE", "REMOVE", "UPSERT", "CONTEXT" ]

Transaction type for annotation

Example: INSERT

{
    "type":"object",
    "properties":{
        "Comment":{
            "$ref":"#/components/schemas/Comment"
        },
        "Flag":{
            "type":"object",
            "properties":{
                "FlagValue":{
                    "$ref":"#/components/schemas/FlagValue"
                },
                "FlagType":{
                    "$ref":"#/components/schemas/FlagType"
                }
            },
            "description":"Flags associated with this annotation",
            "example":[
                {
                    "flagOID":"FLAG1"
                }
            ]
        },
        "SeqNum":{
            "type":"integer",
            "description":"Sequence number for annotation",
            "format":"int32",
            "example":1
        },
        "TransactionType":{
            "type":"string",
            "description":"Transaction type for annotation",
            "example":"INSERT",
            "enum":[
                "INSERT",
                "UPDATE",
                "REMOVE",
                "UPSERT",
                "CONTEXT"
            ]
        },
        "ID":{
            "type":"string",
            "description":"Annotation identifier",
            "example":"AN1"
        }
    },
    "description":"Annotations for the item group",
    "example":[
        {
            "annotationOID":"AN1"
        }
    ]
}

Example:

[
    {
        "annotationOID":"AN1"
    }
]

Nested Schema : Items

Type: object

Contained item data list

Show Source

Annotation: object Annotation

Annotations for this item
AuditRecord: object AuditRecord
DocumentId: string

Document ID reference

Example: DOC1
DocumentVersion: number

Document version

Example: 1
ItemOID: string

OID of the item

Example: ITM1
MeasurementUnitRef: object MeasurementUnitRef

Measurement unit reference
NotDone: string

Whether item is not done (0 or 1)

Example: 0
ParentItemOID: string

OID of parent item

Example: ITM_PARENT
SelectedCodeListItemsType: string

Selected code list items type

Example: CODE_A
Signature: object Signature
TransactionType: string

Allowed Values: [ "INSERT", "UPDATE", "REMOVE", "UPSERT", "CONTEXT" ]

Transaction type

Example: UPDATE
Value: string

Value for this item

Example: 130

{
    "type":"object",
    "properties":{
        "AuditRecord":{
            "$ref":"#/components/schemas/AuditRecord"
        },
        "Signature":{
            "$ref":"#/components/schemas/Signature"
        },
        "MeasurementUnitRef":{
            "$ref":"#/components/schemas/MeasurementUnitRef"
        },
        "Annotation":{
            "type":"object",
            "properties":{
                "Comment":{
                    "$ref":"#/components/schemas/Comment"
                },
                "Flag":{
                    "type":"object",
                    "properties":{
                        "FlagValue":{
                            "$ref":"#/components/schemas/FlagValue"
                        },
                        "FlagType":{
                            "$ref":"#/components/schemas/FlagType"
                        }
                    },
                    "description":"Flags associated with this annotation",
                    "example":[
                        {
                            "flagOID":"FLAG1"
                        }
                    ]
                },
                "SeqNum":{
                    "type":"integer",
                    "description":"Sequence number for annotation",
                    "format":"int32",
                    "example":1
                },
                "TransactionType":{
                    "type":"string",
                    "description":"Transaction type for annotation",
                    "example":"INSERT",
                    "enum":[
                        "INSERT",
                        "UPDATE",
                        "REMOVE",
                        "UPSERT",
                        "CONTEXT"
                    ]
                },
                "ID":{
                    "type":"string",
                    "description":"Annotation identifier",
                    "example":"AN1"
                }
            },
            "description":"Annotations for this item",
            "example":[
                {
                    "id":"AN1"
                }
            ]
        },
        "ItemOID":{
            "type":"string",
            "description":"OID of the item",
            "example":"ITM1"
        },
        "TransactionType":{
            "type":"string",
            "description":"Transaction type",
            "example":"UPDATE",
            "enum":[
                "INSERT",
                "UPDATE",
                "REMOVE",
                "UPSERT",
                "CONTEXT"
            ]
        },
        "ParentItemOID":{
            "type":"string",
            "description":"OID of parent item",
            "example":"ITM_PARENT"
        },
        "NotDone":{
            "type":"string",
            "description":"Whether item is not done (0 or 1)",
            "example":"0"
        },
        "SelectedCodeListItemsType":{
            "type":"string",
            "description":"Selected code list items type",
            "example":"CODE_A"
        },
        "Value":{
            "type":"string",
            "description":"Value for this item",
            "example":"130"
        },
        "DocumentId":{
            "type":"string",
            "description":"Document ID reference",
            "example":"DOC1"
        },
        "DocumentVersion":{
            "type":"number",
            "description":"Document version",
            "example":1
        }
    },
    "description":"Contained item data list",
    "example":[
        {
            "itemOID":"ITM1"
        }
    ]
}

Example:

[
    {
        "itemOID":"ITM1"
    }
]

Nested Schema : Flag

Type: object

Flags associated with this annotation

Show Source

FlagType: object FlagType
FlagValue: object FlagValue

{
    "type":"object",
    "properties":{
        "FlagValue":{
            "$ref":"#/components/schemas/FlagValue"
        },
        "FlagType":{
            "$ref":"#/components/schemas/FlagType"
        }
    },
    "description":"Flags associated with this annotation",
    "example":[
        {
            "flagOID":"FLAG1"
        }
    ]
}

Example:

[
    {
        "flagOID":"FLAG1"
    }
]

Nested Schema : Annotation

Type: object

Annotations for this item

Show Source

Comment: object Comment

Annotation comment object
Flag: object Flag

Flags associated with this annotation
ID: string

Annotation identifier

Example: AN1
SeqNum: integer (int32)

Sequence number for annotation

Example: 1
TransactionType: string

Allowed Values: [ "INSERT", "UPDATE", "REMOVE", "UPSERT", "CONTEXT" ]

Transaction type for annotation

Example: INSERT

{
    "type":"object",
    "properties":{
        "Comment":{
            "$ref":"#/components/schemas/Comment"
        },
        "Flag":{
            "type":"object",
            "properties":{
                "FlagValue":{
                    "$ref":"#/components/schemas/FlagValue"
                },
                "FlagType":{
                    "$ref":"#/components/schemas/FlagType"
                }
            },
            "description":"Flags associated with this annotation",
            "example":[
                {
                    "flagOID":"FLAG1"
                }
            ]
        },
        "SeqNum":{
            "type":"integer",
            "description":"Sequence number for annotation",
            "format":"int32",
            "example":1
        },
        "TransactionType":{
            "type":"string",
            "description":"Transaction type for annotation",
            "example":"INSERT",
            "enum":[
                "INSERT",
                "UPDATE",
                "REMOVE",
                "UPSERT",
                "CONTEXT"
            ]
        },
        "ID":{
            "type":"string",
            "description":"Annotation identifier",
            "example":"AN1"
        }
    },
    "description":"Annotations for this item",
    "example":[
        {
            "id":"AN1"
        }
    ]
}

Example:

[
    {
        "id":"AN1"
    }
]

Nested Schema : MeasurementUnitRef

Type: object

Measurement unit reference

Show Source

MeasurementUnitOID: string

OID of the referenced measurement unit

Example: U1

{
    "type":"object",
    "properties":{
        "MeasurementUnitOID":{
            "type":"string",
            "description":"OID of the referenced measurement unit",
            "example":"U1"
        }
    },
    "description":"Measurement unit reference",
    "example":{
        "measurementUnitOID":"U1"
    }
}

Example:

{
    "measurementUnitOID":"U1"
}

Nested Schema : Flag

Type: object

Flags associated with this annotation

Show Source

FlagType: object FlagType
FlagValue: object FlagValue

{
    "type":"object",
    "properties":{
        "FlagValue":{
            "$ref":"#/components/schemas/FlagValue"
        },
        "FlagType":{
            "$ref":"#/components/schemas/FlagType"
        }
    },
    "description":"Flags associated with this annotation",
    "example":[
        {
            "flagOID":"FLAG1"
        }
    ]
}

Example:

[
    {
        "flagOID":"FLAG1"
    }
]

Nested Schema : RepeatingFormData

Type: array

Show Source

Array of: object RepeatingFormData

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

Nested Schema : RepeatingFormData

Type: object

Show Source

FormHeader: array FormHeader
FormID: string
FormOID: string
Row: array Row
SummaryNote: string

{
    "type":"object",
    "properties":{
        "FormOID":{
            "type":"string"
        },
        "FormID":{
            "type":"string"
        },
        "FormHeader":{
            "type":"array",
            "items":{
                "$ref":"#/components/schemas/FormHeader"
            }
        },
        "Row":{
            "type":"array",
            "items":{
                "$ref":"#/components/schemas/Row"
            }
        },
        "SummaryNote":{
            "type":"string"
        }
    }
}

Nested Schema : FormHeader

Type: array

Show Source

Array of: object FormHeader

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

Nested Schema : Row

Type: array

Show Source

Array of: object Row

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

Nested Schema : FormHeader

Type: object

Show Source

Itemset: boolean
ItemsetHeader: string
Name: string
OID: string

{
    "type":"object",
    "properties":{
        "Itemset":{
            "type":"boolean"
        },
        "ItemsetHeader":{
            "type":"string"
        },
        "Name":{
            "type":"string"
        },
        "OID":{
            "type":"string"
        }
    }
}

Nested Schema : Row

Type: object

Show Source

Associated: boolean
AssociatedFormList: array AssociatedFormList
Deleted: boolean
FormIndex: number
Item: array Item
RowNo: string

{
    "type":"object",
    "properties":{
        "AssociatedFormList":{
            "type":"array",
            "items":{
                "$ref":"#/components/schemas/AssociatedFormList"
            }
        },
        "RowNo":{
            "type":"string"
        },
        "FormIndex":{
            "type":"number"
        },
        "Associated":{
            "type":"boolean"
        },
        "Deleted":{
            "type":"boolean"
        },
        "Item":{
            "type":"array",
            "items":{
                "$ref":"#/components/schemas/Item"
            }
        }
    }
}

Nested Schema : AssociatedFormList

Type: array

Show Source

Array of: object AssociatedFormList

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

Nested Schema : Item

Type: array

Show Source

Array of: object Item

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

Nested Schema : AssociatedFormList

Type: object

Show Source

AuditTrail: array AuditTrail
Deleted: boolean
FormIndex: number
FormName: string
FormOID: string
InstanceNumber: integer
VisitIndex: number
VisitName: string
VisitOID: string

{
    "type":"object",
    "properties":{
        "AuditTrail":{
            "type":"array",
            "items":{
                "$ref":"#/components/schemas/AuditTrail"
            }
        },
        "FormOID":{
            "type":"string"
        },
        "FormIndex":{
            "type":"number"
        },
        "FormName":{
            "type":"string"
        },
        "VisitOID":{
            "type":"string"
        },
        "VisitIndex":{
            "type":"number"
        },
        "VisitName":{
            "type":"string"
        },
        "Deleted":{
            "type":"boolean"
        },
        "InstanceNumber":{
            "type":"integer"
        }
    }
}

Nested Schema : AuditTrail

Type: array

Show Source

Array of: object AuditTrail

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

Nested Schema : AuditTrail

Type: object

Show Source

DateTimeStamp: string
Deleted: boolean
Note: string
User: string

{
    "type":"object",
    "properties":{
        "DateTimeStamp":{
            "type":"string"
        },
        "User":{
            "type":"string"
        },
        "Deleted":{
            "type":"boolean"
        },
        "Note":{
            "type":"string"
        }
    }
}

Nested Schema : Item

Type: object

Show Source

Itemset: boolean
ItemsetRows: string
OID: string
Value: string

{
    "type":"object",
    "properties":{
        "Itemset":{
            "type":"boolean"
        },
        "ItemsetRows":{
            "type":"string"
        },
        "Value":{
            "type":"string"
        },
        "OID":{
            "type":"string"
        }
    }
}

Nested Schema : TransferData

Type: object

Show Source

FromSiteName: string
ToSiteName: string
TransferDate: string

{
    "type":"object",
    "properties":{
        "FromSiteName":{
            "type":"string"
        },
        "ToSiteName":{
            "type":"string"
        },
        "TransferDate":{
            "type":"string"
        }
    }
}

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

Request

Response

200 Response

400 Response