• Array of: object ClinicalData

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

• 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
            }
        }
    },
    "xml":{
        "name":"ClinicalData",
        "namespace":"http://www.cdisc.org/ns/odm/v1.3"
    }
}

• Array of: object Annotations

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

• Array of: object AuditRecords

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

• Array of: object Signatures

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

• Array of: object SubjectData

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

• annotation: array Annotation

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

• Array of: object Annotation

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

• 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"
    }
}

• 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"
            ]
        }
    }
}

• Array of: object Flag

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

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

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

• codeListOID: string
• value: string

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

• codeListOID: string
• value: string

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

• auditRecord: array AuditRecord

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

• Array of: object AuditRecord

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

• dateTimeStamp(required): object DateTimeStamp
• editPoint: string
  Allowed Values: [ "MONITORING", "DATA_MANAGEMENT", "DB_AUDIT" ]
• id: string
• locationRef(required): object LocationRef
• reasonForChange: object ReasonForChange
• sourceID: object SourceID
• usedImputationMethod: string
  Allowed Values: [ "YES", "NO" ]
• userRef(required): object UserRef

{
    "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",
            "xml":{
                "name":"UsedImputationMethod",
                "attribute":true
            },
            "enum":[
                "YES",
                "NO"
            ]
        },
        "id":{
            "type":"string",
            "xml":{
                "name":"ID",
                "attribute":true
            }
        }
    }
}

• value: string (date-time)

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

• locationOID: string

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

• value: string

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

• value: string

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

• userOID: string

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

• signature: array Signature

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

• Array of: object Signature

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

• 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
            }
        }
    }
}

• value: string

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

• signatureOID: string

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

• 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"
    }
}

• Array of: object Annotation

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

• userOID: string

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

• 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"
    }
}

• Array of: object StudyEventData

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

• 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"
    }
}

• Array of: object Annotation

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

• Array of: object FormData

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

• 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"
    }
}

• Array of: object Annotation

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

• archiveLayoutOID: string

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

• Array of: object ItemGroupData

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

• 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"
    }
}

• Array of: object Annotation

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

• Array of: object ItemData

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

• Array of: object items

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

• annotation: array Annotation
• auditRecord: object AuditRecord
• isNull: string
  Allowed Values: [ "YES" ]
• itemOID: string
• measurementUnitRef: object MeasurementUnitRef
• signature: object Signature
• transactionType: string
  Allowed Values: [ "INSERT", "UPDATE", "REMOVE", "UPSERT", "CONTEXT" ]
• value: string

{
    "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"
    }
}

• Array of: object Annotation

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

• measurementUnitOID: string

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