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• Request
• Response

V10.0

get

/ec-datahub-svc/rest/v10.0/studies/{studyId}/{mode}/odm/metadata

This API is used to extract meta data in the CDISC ODM-XML format. In this version, a new Clinical One extension attribute CodelistLinkType is introduced. This attribute specifies whether an item is associated with STATIC or DYNAMIC codelists.

Request

Path Parameters

• mode(required): string
  Indicates the operational mode of the study. Accepted values: active, test, or training.
• studyId(required): string
  Unique identifier of the study. Uses UUID in a 32-character uppercase hexadecimal string format.

Query Parameters

• fromTimestamp: string(date-time)
  Extract study versions that were created after this timestamp only in the ODM Extract. It accepts yyyy-MM-dd'T'HH:mm:ss.SSS'Z' date format.

  Example:

  2024-01-01T00:00:00Z

• includeCOExtensions: boolean
  If the value is true, the data extract will include both the CDISC standard elements and Clinical One extension elements in the extract. If the value is false, the extracted data will only consist of the CDISC standard elements. It accepts true or false, or y or n. The default value is true.

  Example:

  true

• limit: integer(int32)
  Minimum Value: 1

  The number of study versions, beginning with the offset, that you want to retrieve. Offset must be provided to use this parameter. For example, if you want to retrieve study versions in multiple batches of 10, you can start with an offset of 0 and limit of 10, then repeat calls to this endpoint and increase the offset value by 10 each time.

  Example:

  100

• offset: integer(int32)
  Minimum Value: 0

  An order number that specifies which study version you want to start retrieving meta data from. If provided, you also need to specify a value for the limit parameter.

  Example:

  0

• studyVersion: string
  The version of the study to extract data from in the ODM Extract.

  Example:

  1.0.0.1

• studyVersionSummary: boolean
  If the value is true, only summary data is displayed for the study version in the ODM extract. If the value is false, both summary data and complete design data is displayed for the study version in the ODM Extract. It accepts true or false, or y or n. The default value is false.

  Example:

  false

There's no request body for this operation.

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Response

Supported Media Types

• application/xml
• application/json

200 Response

Successful operation

Body ()

Root Schema : ODM

Type: object

Clinical One ODM 1.3.2 study metadata container including pagination and export attributes.

Show Source

• Archival: string
  Indicates archival export.

  Example: Yes
• AsOfDateTime: string (date-time)
  Effective timestamp for the data represented.

  Example: 2024-06-15T10:30:00Z
• count: integer (int32)
  Number of results in current page.

  Example: 1
• CreationDateTime: string (date-time)
  Timestamp when the payload was generated.

  Example: 2024-06-15T10:30:00Z
• Description: string
  Description of the ODM export file.

  Example: Study metadata export
• excludeHiddenData: string
  Whether hidden data is excluded from the payload.

  Example: false
• FileOID: string (uuid)
  Unique identifier for the exported file.
• 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"/>
• fromTimestamp: string (date-time)
  Start timestamp filter for changes included in payload.

  Example: 2024-01-01T00:00:00Z
• 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 whether more results are available for pagination.

  Example: false
• ID: string (uuid)
  Unique identifier of the ODM document.
• includeCOExtensions: string
  Whether to include Clinical One extension attributes in the payload.

  Example: true
• includeLocations: string
  Location inclusion filter for metadata export.

  Example: all
• includeUsers: string
  User inclusion filter for metadata export.

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

  Page size for pagination.

  Example: 100
• ODMVersion: string
  ODM version of the payload.

  Example: 1.3.2
• offset: integer (int32)
  Offset for pagination.

  Example: 0
• Originator: string
  Name of the system originating the payload.

  Example: ClinicalOne
• PriorFileOID: string (uuid)
  Identifier of the prior exported file if any.
• SourceSystem: string
  Name of the source system.

  Example: ClinicalOne DataHub
• SourceSystemVersion: string
  Version of the source system.

  Example: 8.0
• study: array Study
  List of ODM Study elements.
• studyMode: string
  Requested study data mode value. Allowed values are test, active or training.

  Example: active
• studyVersion: string
  Study version identifier.

  Example: 1.0.0
• studyVersionSummary: boolean
  If true, include study version summary instead of full detail.

  Example: true
• totalResults: integer (int32)
  Total number of results available.

  Example: 1
• toTimestamp: string (date-time)
  End timestamp filter for changes included in payload.

  Example: 2024-12-31T23:59:59Z

{
    "type":"object",
    "properties":{
        "study":{
            "type":"array",
            "description":"List of ODM Study elements.",
            "example":[
            ],
            "xml":{
                "name":"Study"
            },
            "items":{
                "$ref":"#/components/schemas/Study"
            }
        },
        "studyMode":{
            "type":"string",
            "description":"Requested study data mode value. Allowed 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":"string",
            "description":"Whether to include Clinical One extension attributes in the payload.",
            "example":"true",
            "xml":{
                "namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
                "attribute":true
            }
        },
        "excludeHiddenData":{
            "type":"string",
            "description":"Whether hidden data is excluded from the payload.",
            "example":"false",
            "xml":{
                "namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
                "attribute":true
            }
        },
        "fromTimestamp":{
            "type":"string",
            "description":"Start timestamp filter for changes included in payload.",
            "format":"date-time",
            "example":"2024-01-01T00:00:00Z",
            "xml":{
                "namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
                "attribute":true
            }
        },
        "toTimestamp":{
            "type":"string",
            "description":"End timestamp filter for changes included in payload.",
            "format":"date-time",
            "example":"2024-12-31T23:59:59Z",
            "xml":{
                "namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
                "attribute":true
            }
        },
        "studyVersion":{
            "type":"string",
            "description":"Study version identifier.",
            "example":"1.0.0",
            "xml":{
                "namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
                "attribute":true
            }
        },
        "studyVersionSummary":{
            "type":"boolean",
            "description":"If true, include study version summary instead of full detail.",
            "example":true,
            "xml":{
                "namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
                "attribute":true
            }
        },
        "includeUsers":{
            "type":"string",
            "description":"User inclusion filter for metadata export.",
            "example":"all",
            "xml":{
                "namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
                "attribute":true
            }
        },
        "includeLocations":{
            "type":"string",
            "description":"Location inclusion filter for metadata export.",
            "example":"all",
            "xml":{
                "namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
                "attribute":true
            }
        },
        "hasMore":{
            "type":"boolean",
            "description":"Indicates whether more results are available for pagination.",
            "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 available.",
            "format":"int32",
            "example":1,
            "xml":{
                "namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
                "attribute":true
            }
        },
        "count":{
            "type":"integer",
            "description":"Number of results in current page.",
            "format":"int32",
            "example":1,
            "xml":{
                "namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
                "attribute":true
            }
        },
        "limit":{
            "minimum":1,
            "type":"integer",
            "description":"Page size for pagination.",
            "format":"int32",
            "example":100,
            "xml":{
                "namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
                "attribute":true
            }
        },
        "offset":{
            "type":"integer",
            "description":"Offset for pagination.",
            "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":"Description of the ODM export file.",
            "example":"Study metadata export",
            "xml":{
                "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 export.",
            "example":"Yes",
            "xml":{
                "attribute":true
            }
        },
        "FileOID":{
            "type":"string",
            "description":"Unique identifier for the exported file.",
            "format":"uuid",
            "xml":{
                "attribute":true
            }
        },
        "CreationDateTime":{
            "type":"string",
            "description":"Timestamp when the payload was generated.",
            "format":"date-time",
            "example":"2024-06-15T10:30:00Z",
            "xml":{
                "attribute":true
            }
        },
        "PriorFileOID":{
            "type":"string",
            "description":"Identifier of the prior exported file if any.",
            "format":"uuid",
            "xml":{
                "attribute":true
            }
        },
        "AsOfDateTime":{
            "type":"string",
            "description":"Effective timestamp for the data represented.",
            "format":"date-time",
            "example":"2024-06-15T10:30:00Z",
            "xml":{
                "attribute":true
            }
        },
        "ODMVersion":{
            "type":"string",
            "description":"ODM version of the payload.",
            "example":"1.3.2",
            "xml":{
                "attribute":true
            }
        },
        "Originator":{
            "type":"string",
            "description":"Name of the system originating the payload.",
            "example":"ClinicalOne",
            "xml":{
                "attribute":true
            }
        },
        "SourceSystem":{
            "type":"string",
            "description":"Name of the source system.",
            "example":"ClinicalOne DataHub",
            "xml":{
                "attribute":true
            }
        },
        "SourceSystemVersion":{
            "type":"string",
            "description":"Version of the source system.",
            "example":"8.0",
            "xml":{
                "attribute":true
            }
        },
        "ID":{
            "type":"string",
            "description":"Unique identifier of the ODM document.",
            "format":"uuid",
            "xml":{
                "attribute":true
            }
        }
    },
    "description":"Clinical One ODM 1.3.2 study metadata container including pagination and export attributes.",
    "example":"<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=\"T15\" FileType=\"Transactional\" FileOID=\"oracle/T15/BF400E2655C4493799A17C7B947557F0\" CreationDateTime=\"2025-11-03T18:14:02.559Z\" ODMVersion=\"1.3.2\" Originator=\"system\" SourceSystem=\"Oracle Life Sciences Clinical One\" SourceSystemVersion=\"MetaData API v10.0\" co:studyMode=\"test\" co:includeCOExtensions=\"true\" co:fromTimestamp=\"2024-01-01T00:00:00Z\" co:studyVersion=\"1.0.0.3\" co:studyVersionSummary=\"false\" co:hasMore=\"false\" co:totalResults=\"1\" co:count=\"1\" co:limit=\"1\" co:offset=\"0\">\n\t<Study OID=\"T15\" co:SafetyIntegrationEnabled=\"false\">\n\t\t<GlobalVariables>\n\t\t\t<StudyName>T15</StudyName>\n\t\t\t<StudyDescription>Test15</StudyDescription>\n\t\t\t<ProtocolName>T15</ProtocolName>\n\t\t</GlobalVariables>\n\t\t<BasicDefinitions>\n\t\t\t<MeasurementUnit OID=\"kg/m2\" Name=\"kg/m2\">\n\t\t\t\t<Symbol>\n\t\t\t\t\t<TranslatedText>kg/m2</TranslatedText>\n\t\t\t\t</Symbol>\n\t\t\t</MeasurementUnit>\n\t\t\t<MeasurementUnit OID=\"Years\" Name=\"Years\">\n\t\t\t\t<Symbol>\n\t\t\t\t\t<TranslatedText>Years</TranslatedText>\n\t\t\t\t</Symbol>\n\t\t\t</MeasurementUnit>\n\t\t</BasicDefinitions>\n\t\t<MetaDataVersion co:StudyWid=\"582\" co:GUID=\"FE9ABAA632634DFA84D1863365689C42\" co:VersionStart=\"2023-06-08T10:54:02.478Z\" OID=\"T15v1.0.0.1\" Name=\"T15\">\n\t\t\t<Protocol>\n\t\t\t\t<StudyEventRef StudyEventOID=\"AE_517E14D0AC2C4319B16D57B54F42CD28\" OrderNumber=\"1\" Mandatory=\"No\"></StudyEventRef>\n\t\t\t\t<StudyEventRef StudyEventOID=\"SV01_32781214B9394105AC61CDE66D28E8D4\" OrderNumber=\"2\" Mandatory=\"Yes\"></StudyEventRef>\n\t\t\t\t<StudyEventRef StudyEventOID=\"BV01_944101E4D1ED4DC8B04D81670969D5B0\" OrderNumber=\"3\" Mandatory=\"Yes\"></StudyEventRef>\n\t\t\t</Protocol>\n\t\t\t<StudyEventDef co:StudyEventWid=\"1557\" co:GUID=\"517E14D0AC2C4319B16D57B54F42CD28\" co:VersionStart=\"2023-06-08T10:54:04.642Z\" OID=\"AE_517E14D0AC2C4319B16D57B54F42CD28\" Name=\"ADVERSEEVENT\" Repeating=\"No\" Type=\"Unscheduled\" Category=\"AdverseEvent\" co:AlertOutsideVisitWindow=\"off\"></StudyEventDef>\n\t\t\t<StudyEventDef co:StudyEventWid=\"1559\" co:GUID=\"32781214B9394105AC61CDE66D28E8D4\" co:VersionStart=\"2023-06-14T16:50:55.978Z\" co:DelayDays=\"0\" co:DelayHours=\"0\" co:DelayWindowBeforeDays=\"0\" co:DelayWindowBeforeHours=\"0\" co:DelayWindowAfterDays=\"0\" co:DelayWindowAfterHours=\"0\" co:DelayWindowHardStop=\"0\" co:DelayWindowVisitApproval=\"0\" OID=\"SV01_32781214B9394105AC61CDE66D28E8D4\" Name=\"SCREENINGVISIT\" Repeating=\"No\" Type=\"Scheduled\" Category=\"ScreeningVisit\" co:AlertOutsideVisitWindow=\"off\">\n\t\t\t\t<FormRef FormOID=\"FORM_01_9EF4AB0095C646638639BE29015BE12B\" OrderNumber=\"1\" Mandatory=\"Yes\"></FormRef>\n\t\t\t</StudyEventDef>\n\t\t\t<StudyEventDef co:StudyEventWid=\"1558\" co:GUID=\"944101E4D1ED4DC8B04D81670969D5B0\" co:VersionStart=\"2023-06-14T16:51:40.385Z\" co:DelayDays=\"1\" co:DelayHours=\"0\" co:DelayWindowBeforeDays=\"0\" co:DelayWindowBeforeHours=\"0\" co:DelayWindowAfterDays=\"0\" co:DelayWindowAfterHours=\"0\" OID=\"BV01_944101E4D1ED4DC8B04D81670969D5B0\" Name=\"BASELINEVISIT\" Repeating=\"No\" Type=\"Scheduled\" Category=\"ScheduleAbleVisit\">\n\t\t\t\t<FormRef FormOID=\"FORM_02_C7A1E7351E7C4E8EB047E76CB5B20AFB\" OrderNumber=\"1\" Mandatory=\"Yes\"></FormRef>\n\t\t\t</StudyEventDef>\n\t\t\t<FormDef OID=\"FORM_01_9EF4AB0095C646638639BE29015BE12B\" Name=\"ScreeningForm\" Repeating=\"No\">\n\t\t\t\t<ItemGroupRef OrderNumber=\"1\" Mandatory=\"Yes\" ItemGroupOID=\"IG_DATETIME_01_F908F5EB04CB48D9999F9253E90AC0E0\"></ItemGroupRef>\n\t\t\t\t<ItemGroupRef OrderNumber=\"2\" Mandatory=\"Yes\" ItemGroupOID=\"IG_RADIOSET_01_39B1292322524D08ACD5102CD149EA54\"></ItemGroupRef>\n\t\t\t\t<ItemGroupRef OrderNumber=\"3\" Mandatory=\"Yes\" ItemGroupOID=\"IG_SMARTITEM_01_AGE_629460FD54724C588E81A9E8F45C88D7\"></ItemGroupRef>\n\t\t\t\t<ItemGroupRef OrderNumber=\"4\" Mandatory=\"Yes\" ItemGroupOID=\"IG_SMARTITEM_02_DOB_4E18C108F99242EF92D2EF97C32FF439\"></ItemGroupRef>\n\t\t\t\t<ItemGroupRef OrderNumber=\"5\" Mandatory=\"Yes\" ItemGroupOID=\"IG_CHECKBOX_01_CAD07B7C05BB4A00B152847CC3D046CD\"></ItemGroupRef>\n\t\t\t\t<ItemGroupRef OrderNumber=\"6\" Mandatory=\"Yes\" ItemGroupOID=\"IG_DROPDOWN_03_EB54E6654075424C802062CDA1F05679\"></ItemGroupRef>\n\t\t\t\t<ItemGroupRef OrderNumber=\"7\" Mandatory=\"Yes\" ItemGroupOID=\"IG_RADIOSET_04_A0B7DDDDABDD413C8ADE7E4A956E8181\"></ItemGroupRef>\n\t\t\t\t<ItemGroupRef OrderNumber=\"8\" Mandatory=\"No\" ItemGroupOID=\"IG_TEXT_34_8D6DCDCC63964661BB25E40319A310D3\"></ItemGroupRef>\n\t\t\t\t<ItemGroupRef OrderNumber=\"9\" Mandatory=\"Yes\" ItemGroupOID=\"IG_NUMBER_04_0F473394D64C420DACDBD90F7819489A\"></ItemGroupRef>\n\t\t\t\t<ItemGroupRef OrderNumber=\"10\" Mandatory=\"Yes\" ItemGroupOID=\"IG_TEXT_35_6A91A1AE09E14A979D5840A16D0FC8D5\"></ItemGroupRef>\n\t\t\t</FormDef>\n\t\t\t<FormDef OID=\"FORM_02_C7A1E7351E7C4E8EB047E76CB5B20AFB\" Name=\"ConMed Form\" Repeating=\"Yes\">\n\t\t\t\t<ItemGroupRef OrderNumber=\"1\" Mandatory=\"Yes\" ItemGroupOID=\"IG_TEXT_01_876B1FFEB83242D1919462E349E08463\"></ItemGroupRef>\n\t\t\t\t<ItemGroupRef OrderNumber=\"2\" Mandatory=\"Yes\" ItemGroupOID=\"IG_DATETIME_02_4BA5316F99404220A8EC0E2EC856A642\"></ItemGroupRef>\n\t\t\t\t<ItemGroupRef OrderNumber=\"3\" Mandatory=\"Yes\" ItemGroupOID=\"IG_TEXT_03_0654B2AF1E2C4FE9912098CC89B7E0A0\"></ItemGroupRef>\n\t\t\t\t<ItemGroupRef OrderNumber=\"4\" Mandatory=\"Yes\" ItemGroupOID=\"IG_TEXT_04_0B7FA31FB3DC418D97C729EE55E1065A\"></ItemGroupRef>\n\t\t\t\t<ItemGroupRef OrderNumber=\"5\" Mandatory=\"Yes\" ItemGroupOID=\"IG_NUMBER_01_2BB97DE583734CB2A03D35F2DC694312\"></ItemGroupRef>\n\t\t\t\t<ItemGroupRef OrderNumber=\"6\" Mandatory=\"No\" ItemGroupOID=\"IG_TEXT_33_465DE0BE9D5F41A5A1D69CC7F1F2674A\"></ItemGroupRef>\n\t\t\t</FormDef>\n\t\t\t<ItemGroupDef OID=\"IG_TEXT_01_876B1FFEB83242D1919462E349E08463\" Name=\"Procedure Name\" Repeating=\"No\">\n\t\t\t\t<ItemRef OrderNumber=\"1\" Mandatory=\"Yes\" ItemOID=\"TEXT_01_876B1FFEB83242D1919462E349E08463\"></ItemRef>\n\t\t\t</ItemGroupDef>\n\t\t\t<ItemGroupDef OID=\"IG_DATETIME_02_4BA5316F99404220A8EC0E2EC856A642\" Name=\"Date Of Procedure\" Repeating=\"No\">\n\t\t\t\t<ItemRef OrderNumber=\"1\" Mandatory=\"Yes\" ItemOID=\"DATETIME_02_4BA5316F99404220A8EC0E2EC856A642\"></ItemRef>\n\t\t\t</ItemGroupDef>\n\t\t\t<ItemGroupDef OID=\"IG_TEXT_03_0654B2AF1E2C4FE9912098CC89B7E0A0\" Name=\"Reason For Procedure\" Repeating=\"No\">\n\t\t\t\t<ItemRef OrderNumber=\"1\" Mandatory=\"Yes\" ItemOID=\"TEXT_03_0654B2AF1E2C4FE9912098CC89B7E0A0\"></ItemRef>\n\t\t\t</ItemGroupDef>\n\t\t\t<ItemGroupDef OID=\"IG_TEXT_04_0B7FA31FB3DC418D97C729EE55E1065A\" Name=\"Dose Recommended\" Repeating=\"No\">\n\t\t\t\t<ItemRef OrderNumber=\"1\" Mandatory=\"Yes\" ItemOID=\"TEXT_04_0B7FA31FB3DC418D97C729EE55E1065A\"></ItemRef>\n\t\t\t</ItemGroupDef>\n\t\t\t<ItemGroupDef OID=\"IG_NUMBER_01_2BB97DE583734CB2A03D35F2DC694312\" Name=\"Dose Units\" Repeating=\"No\">\n\t\t\t\t<ItemRef OrderNumber=\"1\" Mandatory=\"Yes\" ItemOID=\"NUMBER_01_2BB97DE583734CB2A03D35F2DC694312\"></ItemRef>\n\t\t\t</ItemGroupDef>\n\t\t\t<ItemGroupDef OID=\"IG_TEXT_33_465DE0BE9D5F41A5A1D69CC7F1F2674A\" Name=\"Dose Period\" Repeating=\"No\">\n\t\t\t\t<ItemRef OrderNumber=\"1\" Mandatory=\"No\" ItemOID=\"TEXT_33_465DE0BE9D5F41A5A1D69CC7F1F2674A\"></ItemRef>\n\t\t\t</ItemGroupDef>\n\t\t\t<ItemGroupDef OID=\"IG_DATETIME_01_F908F5EB04CB48D9999F9253E90AC0E0\" Name=\"Screening date\" Repeating=\"No\">\n\t\t\t\t<ItemRef OrderNumber=\"1\" Mandatory=\"Yes\" ItemOID=\"DATETIME_01_F908F5EB04CB48D9999F9253E90AC0E0\"></ItemRef>\n\t\t\t</ItemGroupDef>\n\t\t\t<ItemGroupDef OID=\"IG_RADIOSET_01_39B1292322524D08ACD5102CD149EA54\" Name=\"Gender\" Repeating=\"No\">\n\t\t\t\t<ItemRef OrderNumber=\"1\" Mandatory=\"Yes\" ItemOID=\"RADIOSET_01_39B1292322524D08ACD5102CD149EA54\"></ItemRef>\n\t\t\t</ItemGroupDef>\n\t\t\t<ItemGroupDef OID=\"IG_SMARTITEM_01_AGE_629460FD54724C588E81A9E8F45C88D7\" Name=\"Age\" Repeating=\"No\">\n\t\t\t\t<ItemRef OrderNumber=\"1\" Mandatory=\"Yes\" ItemOID=\"SMARTITEM_01_AGE_629460FD54724C588E81A9E8F45C88D7\"></ItemRef>\n\t\t\t</ItemGroupDef>\n\t\t\t<ItemGroupDef OID=\"IG_SMARTITEM_02_DOB_4E18C108F99242EF92D2EF97C32FF439\" Name=\"Age_SMARTITEM_02_DOB\" Repeating=\"No\">\n\t\t\t\t<ItemRef OrderNumber=\"1\" Mandatory=\"Yes\" ItemOID=\"SMARTITEM_02_DOB_4E18C108F99242EF92D2EF97C32FF439\"></ItemRef>\n\t\t\t</ItemGroupDef>\n\t\t\t<ItemGroupDef OID=\"IG_CHECKBOX_01_CAD07B7C05BB4A00B152847CC3D046CD\" Name=\"Fasting\" Repeating=\"No\">\n\t\t\t\t<ItemRef OrderNumber=\"1\" Mandatory=\"Yes\" ItemOID=\"CHECKBOX_01_CAD07B7C05BB4A00B152847CC3D046CD\"></ItemRef>\n\t\t\t</ItemGroupDef>\n\t\t\t<ItemGroupDef OID=\"IG_DROPDOWN_03_EB54E6654075424C802062CDA1F05679\" Name=\"Race\" Repeating=\"No\">\n\t\t\t\t<ItemRef OrderNumber=\"1\" Mandatory=\"Yes\" ItemOID=\"DROPDOWN_03_EB54E6654075424C802062CDA1F05679\"></ItemRef>\n\t\t\t</ItemGroupDef>\n\t\t\t<ItemGroupDef OID=\"IG_RADIOSET_04_A0B7DDDDABDD413C8ADE7E4A956E8181\" Name=\"Is RollOver Question?\" Repeating=\"No\">\n\t\t\t\t<ItemRef OrderNumber=\"1\" Mandatory=\"Yes\" ItemOID=\"RADIOSET_04_A0B7DDDDABDD413C8ADE7E4A956E8181\"></ItemRef>\n\t\t\t</ItemGroupDef>\n\t\t\t<ItemGroupDef OID=\"IG_TEXT_34_8D6DCDCC63964661BB25E40319A310D3\" Name=\"Screening Initials\" Repeating=\"No\">\n\t\t\t\t<ItemRef OrderNumber=\"1\" Mandatory=\"No\" ItemOID=\"TEXT_34_8D6DCDCC63964661BB25E40319A310D3\"></ItemRef>\n\t\t\t</ItemGroupDef>\n\t\t\t<ItemGroupDef OID=\"IG_NUMBER_04_0F473394D64C420DACDBD90F7819489A\" Name=\"Body Mass Index(BMI)\" Repeating=\"No\">\n\t\t\t\t<ItemRef OrderNumber=\"1\" Mandatory=\"Yes\" ItemOID=\"NUMBER_04_0F473394D64C420DACDBD90F7819489A\"></ItemRef>\n\t\t\t</ItemGroupDef>\n\t\t\t<ItemGroupDef OID=\"IG_TEXT_35_6A91A1AE09E14A979D5840A16D0FC8D5\" Name=\"Symptoms\" Repeating=\"No\">\n\t\t\t\t<ItemRef OrderNumber=\"1\" Mandatory=\"Yes\" ItemOID=\"TEXT_35_6A91A1AE09E14A979D5840A16D0FC8D5\"></ItemRef>\n\t\t\t</ItemGroupDef>\n\t\t\t<ItemDef co:ItemWid=\"6373\" co:GUID=\"876B1FFEB83242D1919462E349E08463\" co:ItemVersionStart=\"2023-06-14T16:28:31.523Z\" co:Precision=\"0\" co:AllowFutureDate=\"No\" OID=\"TEXT_01_876B1FFEB83242D1919462E349E08463\" Name=\"TEXT_01\" DataType=\"string\" Length=\"4000\">\n\t\t\t\t<Question>\n\t\t\t\t\t<TranslatedText>Procedure Name</TranslatedText>\n\t\t\t\t</Question>\n\t\t\t</ItemDef>\n\t\t\t<ItemDef co:ItemWid=\"6372\" co:GUID=\"4BA5316F99404220A8EC0E2EC856A642\" co:ItemVersionStart=\"2023-06-14T16:28:31.517Z\" co:Precision=\"0\" co:AllowFutureDate=\"No\" OID=\"DATETIME_02_4BA5316F99404220A8EC0E2EC856A642\" Name=\"DATETIME_02\" DataType=\"date\">\n\t\t\t\t<Question>\n\t\t\t\t\t<TranslatedText>Date Of Procedure</TranslatedText>\n\t\t\t\t</Question>\n\t\t\t</ItemDef>\n\t\t\t<ItemDef co:ItemWid=\"6381\" co:GUID=\"0654B2AF1E2C4FE9912098CC89B7E0A0\" co:ItemVersionStart=\"2023-06-14T16:28:31.515Z\" co:Precision=\"0\" co:AllowFutureDate=\"No\" OID=\"TEXT_03_0654B2AF1E2C4FE9912098CC89B7E0A0\" Name=\"TEXT_03\" DataType=\"string\" Length=\"4000\">\n\t\t\t\t<Question>\n\t\t\t\t\t<TranslatedText>Reason For Procedure</TranslatedText>\n\t\t\t\t</Question>\n\t\t\t</ItemDef>\n\t\t\t<ItemDef co:ItemWid=\"6369\" co:GUID=\"0B7FA31FB3DC418D97C729EE55E1065A\" co:ItemVersionStart=\"2023-06-14T16:28:31.510Z\" co:Precision=\"0\" co:AllowFutureDate=\"No\" OID=\"TEXT_04_0B7FA31FB3DC418D97C729EE55E1065A\" Name=\"TEXT_04\" DataType=\"string\" Length=\"4000\">\n\t\t\t\t<Question>\n\t\t\t\t\t<TranslatedText>Dose Recommended</TranslatedText>\n\t\t\t\t</Question>\n\t\t\t</ItemDef>\n\t\t\t<ItemDef co:ItemWid=\"6370\" co:GUID=\"2BB97DE583734CB2A03D35F2DC694312\" co:ItemVersionStart=\"2023-06-14T16:28:31.450Z\" co:Precision=\"0\" co:AllowFutureDate=\"No\" OID=\"NUMBER_01_2BB97DE583734CB2A03D35F2DC694312\" Name=\"NUMBER_01\" DataType=\"integer\">\n\t\t\t\t<Question>\n\t\t\t\t\t<TranslatedText>Dose Units</TranslatedText>\n\t\t\t\t</Question>\n\t\t\t</ItemDef>\n\t\t\t<ItemDef co:ItemWid=\"6368\" co:GUID=\"465DE0BE9D5F41A5A1D69CC7F1F2674A\" co:ItemVersionStart=\"2023-06-14T16:47:12.375Z\" co:Precision=\"0\" co:AllowFutureDate=\"No\" OID=\"TEXT_33_465DE0BE9D5F41A5A1D69CC7F1F2674A\" Name=\"TEXT_33\" DataType=\"string\" Length=\"4000\">\n\t\t\t\t<Question>\n\t\t\t\t\t<TranslatedText>Dose Period</TranslatedText>\n\t\t\t\t</Question>\n\t\t\t</ItemDef>\n\t\t\t<ItemDef co:ItemWid=\"6378\" co:GUID=\"F908F5EB04CB48D9999F9253E90AC0E0\" co:ItemVersionStart=\"2023-06-14T16:47:59.124Z\" co:Precision=\"0\" co:AllowFutureDate=\"No\" OID=\"DATETIME_01_F908F5EB04CB48D9999F9253E90AC0E0\" Name=\"DATETIME_01\" DataType=\"date\">\n\t\t\t\t<Question>\n\t\t\t\t\t<TranslatedText>Screening date</TranslatedText>\n\t\t\t\t</Question>\n\t\t\t</ItemDef>\n\t\t\t<ItemDef co:ItemWid=\"6367\" co:GUID=\"39B1292322524D08ACD5102CD149EA54\" co:ItemVersionStart=\"2023-06-14T16:50:02.321Z\" co:Precision=\"1\" co:AllowFutureDate=\"No\" OID=\"RADIOSET_01_39B1292322524D08ACD5102CD149EA54\" Name=\"RADIOSET_01\" DataType=\"string\">\n\t\t\t\t<Question>\n\t\t\t\t\t<TranslatedText>Gender</TranslatedText>\n\t\t\t\t</Question>\n\t\t\t\t<CodeListRef CodeListOID=\"RADIOSET_01_GENDER_E0DF1B7FD6B34ABCB134AEA77F5C82E1\"></CodeListRef>\n\t\t\t</ItemDef>\n\t\t\t<ItemDef co:ItemWid=\"6379\" co:GUID=\"629460FD54724C588E81A9E8F45C88D7\" co:ItemVersionStart=\"2023-06-14T16:50:02.360Z\" co:Precision=\"0\" co:AllowFutureDate=\"No\" co:DataClassification='Sponsor Data' OID=\"SMARTITEM_01_AGE_629460FD54724C588E81A9E8F45C88D7\" Name=\"SMARTITEM_01_AGE\" DataType=\"integer\">\n\t\t\t\t<Question>\n\t\t\t\t\t<TranslatedText>Age</TranslatedText>\n\t\t\t\t</Question>\n\t\t\t\t<MeasurementUnitRef MeasurementUnitOID=\"Years\"></MeasurementUnitRef>\n\t\t\t</ItemDef>\n\t\t\t<ItemDef co:ItemWid=\"6375\" co:GUID=\"4E18C108F99242EF92D2EF97C32FF439\" co:ItemVersionStart=\"2023-06-14T16:50:02.404Z\" co:Precision=\"0\" co:AllowFutureDate=\"No\" co:DataClassification='Sponsor Data' OID=\"SMARTITEM_02_DOB_4E18C108F99242EF92D2EF97C32FF439\" Name=\"SMARTITEM_02_DOB\" DataType=\"date\">\n\t\t\t\t<Question>\n\t\t\t\t\t<TranslatedText>Age_SMARTITEM_02_DOB</TranslatedText>\n\t\t\t\t</Question>\n\t\t\t</ItemDef>\n\t\t\t<ItemDef co:ItemWid=\"6371\" co:GUID=\"CAD07B7C05BB4A00B152847CC3D046CD\" co:ItemVersionStart=\"2023-06-14T16:47:59.131Z\" co:Precision=\"1\" co:AllowFutureDate=\"No\" co:CodelistLinkType=\"STATIC\" OID=\"CHECKBOX_01_CAD07B7C05BB4A00B152847CC3D046CD\" Name=\"CHECKBOX_01\" DataType=\"string\">\n\t\t\t\t<Question>\n\t\t\t\t\t<TranslatedText>Fasting</TranslatedText>\n\t\t\t\t</Question>\n\t\t\t\t<CodeListRef CodeListOID=\"CHECKBOX_01_FASTING_380D34D8478D45C9B72ED700A294D05F\"></CodeListRef>\n\t\t\t</ItemDef>\n\t\t\t<ItemDef co:ItemWid=\"6376\" co:GUID=\"EB54E6654075424C802062CDA1F05679\" co:ItemVersionStart=\"2023-06-14T16:50:02.489Z\" co:Precision=\"1\" co:AllowFutureDate=\"No\" co:CodelistLinkType=\"STATIC\" OID=\"DROPDOWN_03_EB54E6654075424C802062CDA1F05679\" Name=\"DROPDOWN_03\" DataType=\"string\">\n\t\t\t\t<Question>\n\t\t\t\t\t<TranslatedText>Race</TranslatedText>\n\t\t\t\t</Question>\n\t\t\t\t<CodeListRef CodeListOID=\"DROPDOWN_03_RACE_8CFA38D416E34DE08E2EC88A3E334503\"></CodeListRef>\n\t\t\t</ItemDef>\n\t\t\t<ItemDef co:ItemWid=\"6374\" co:GUID=\"A0B7DDDDABDD413C8ADE7E4A956E8181\" co:ItemVersionStart=\"2023-06-14T16:50:02.542Z\" co:Precision=\"1\" co:AllowFutureDate=\"No\" co:CodelistLinkType=\"DYNAMIC\" OID=\"RADIOSET_04_A0B7DDDDABDD413C8ADE7E4A956E8181\" Name=\"RADIOSET_04\" DataType=\"string\">\n\t\t\t\t<Question>\n\t\t\t\t\t<TranslatedText>Is RollOver Question?</TranslatedText>\n\t\t\t\t</Question>\n\t\t\t\t<CodeListRef CodeListOID=\"RADIOSET_04_FASTING_4F9EE6A9C16049B69F0023A632C0CD19\"></CodeListRef>\n\t\t\t</ItemDef>\n\t\t\t<ItemDef co:ItemWid=\"6380\" co:GUID=\"8D6DCDCC63964661BB25E40319A310D3\" co:ItemVersionStart=\"2023-06-14T16:47:59.115Z\" co:Precision=\"0\" co:AllowFutureDate=\"No\" OID=\"TEXT_34_8D6DCDCC63964661BB25E40319A310D3\" Name=\"TEXT_34\" DataType=\"string\" Length=\"4000\">\n\t\t\t\t<Question>\n\t\t\t\t\t<TranslatedText>Screening Initials</TranslatedText>\n\t\t\t\t</Question>\n\t\t\t</ItemDef>\n\t\t\t<ItemDef co:ItemWid=\"6377\" co:GUID=\"0F473394D64C420DACDBD90F7819489A\" co:ItemVersionStart=\"2023-06-14T16:47:59.126Z\" co:Precision=\"1\" co:AllowFutureDate=\"No\" OID=\"NUMBER_04_0F473394D64C420DACDBD90F7819489A\" Name=\"NUMBER_04\" DataType=\"float\">\n\t\t\t\t<Question>\n\t\t\t\t\t<TranslatedText>Body Mass Index(BMI)</TranslatedText>\n\t\t\t\t</Question>\n\t\t\t\t<MeasurementUnitRef MeasurementUnitOID=\"kg/m2\"></MeasurementUnitRef>\n\t\t\t</ItemDef>\n\t\t\t<ItemDef co:ItemWid=\"6430\" co:GUID=\"6A91A1AE09E14A979D5840A16D0FC8D5\" co:ItemVersionStart=\"2024-04-23T11:45:54.330Z\" co:Precision=\"0\" co:AllowFutureDate=\"No\" OID=\"TEXT_35_6A91A1AE09E14A979D5840A16D0FC8D5\" Name=\"TEXT_35\" DataType=\"string\" Length=\"4000\">\n\t\t\t\t<Question>\n\t\t\t\t\t<TranslatedText>Symptoms</TranslatedText>\n\t\t\t\t</Question>\n\t\t\t</ItemDef>\n\t\t\t<CodeList OID=\"RADIOSET_01_GENDER_E0DF1B7FD6B34ABCB134AEA77F5C82E1\" Name=\"Gender\" DataType=\"string\">\n\t\t\t\t<CodeListItem co:SelectionOID=\"RADIOSET_01_GENDER_E0DF1B7FD6B34ABCB134AEA77F5C82E1_RADIOSET_01\" CodedValue=\"C45\">\n\t\t\t\t\t<Decode>\n\t\t\t\t\t\t<TranslatedText>Male</TranslatedText>\n\t\t\t\t\t</Decode>\n\t\t\t\t</CodeListItem>\n\t\t\t\t<CodeListItem co:SelectionOID=\"RADIOSET_01_GENDER_E0DF1B7FD6B34ABCB134AEA77F5C82E1_RADIOSET_02\" CodedValue=\"C46\">\n\t\t\t\t\t<Decode>\n\t\t\t\t\t\t<TranslatedText>Female</TranslatedText>\n\t\t\t\t\t</Decode>\n\t\t\t\t</CodeListItem>\n\t\t\t</CodeList>\n\t\t\t<CodeList OID=\"CHECKBOX_01_FASTING_380D34D8478D45C9B72ED700A294D05F\" Name=\"Fasting\" DataType=\"string\">\n\t\t\t\t<CodeListItem co:SelectionOID=\"CHECKBOX_01_FASTING_380D34D8478D45C9B72ED700A294D05F_CHECKBOX_01\" CodedValue=\"C10\">\n\t\t\t\t\t<Decode>\n\t\t\t\t\t\t<TranslatedText>Yes</TranslatedText>\n\t\t\t\t\t</Decode>\n\t\t\t\t</CodeListItem>\n\t\t\t\t<CodeListItem co:SelectionOID=\"CHECKBOX_01_FASTING_380D34D8478D45C9B72ED700A294D05F_CHECKBOX_02\" CodedValue=\"C11\">\n\t\t\t\t\t<Decode>\n\t\t\t\t\t\t<TranslatedText>No</TranslatedText>\n\t\t\t\t\t</Decode>\n\t\t\t\t</CodeListItem>\n\t\t\t</CodeList>\n\t\t\t<CodeList OID=\"RADIOSET_04_FASTING_4F9EE6A9C16049B69F0023A632C0CD19\" Name=\"Fasting\" DataType=\"string\">\n\t\t\t\t<CodeListItem co:SelectionOID=\"RADIOSET_04_FASTING_4F9EE6A9C16049B69F0023A632C0CD19_RADIOSET_01\" CodedValue=\"C10\">\n\t\t\t\t\t<Decode>\n\t\t\t\t\t\t<TranslatedText>Yes</TranslatedText>\n\t\t\t\t\t</Decode>\n\t\t\t\t</CodeListItem>\n\t\t\t\t<CodeListItem co:SelectionOID=\"RADIOSET_04_FASTING_4F9EE6A9C16049B69F0023A632C0CD19_RADIOSET_02\" CodedValue=\"C11\">\n\t\t\t\t\t<Decode>\n\t\t\t\t\t\t<TranslatedText>No</TranslatedText>\n\t\t\t\t\t</Decode>\n\t\t\t\t</CodeListItem>\n\t\t\t</CodeList>\n\t\t\t<CodeList OID=\"DROPDOWN_03_RACE_8CFA38D416E34DE08E2EC88A3E334503\" Name=\"Race\" DataType=\"string\">\n\t\t\t\t<CodeListItem co:SelectionOID=\"DROPDOWN_03_RACE_8CFA38D416E34DE08E2EC88A3E334503_DROPDOWN_01\" CodedValue=\"C89\">\n\t\t\t\t\t<Decode>\n\t\t\t\t\t\t<TranslatedText>African American</TranslatedText>\n\t\t\t\t\t</Decode>\n\t\t\t\t</CodeListItem>\n\t\t\t\t<CodeListItem co:SelectionOID=\"DROPDOWN_03_RACE_8CFA38D416E34DE08E2EC88A3E334503_DROPDOWN_02\" CodedValue=\"C90\">\n\t\t\t\t\t<Decode>\n\t\t\t\t\t\t<TranslatedText>American Indian</TranslatedText>\n\t\t\t\t\t</Decode>\n\t\t\t\t</CodeListItem>\n\t\t\t\t<CodeListItem co:SelectionOID=\"DROPDOWN_03_RACE_8CFA38D416E34DE08E2EC88A3E334503_DROPDOWN_03\" CodedValue=\"C91\">\n\t\t\t\t\t<Decode>\n\t\t\t\t\t\t<TranslatedText>Asian</TranslatedText>\n\t\t\t\t\t</Decode>\n\t\t\t\t</CodeListItem>\n\t\t\t\t<CodeListItem co:SelectionOID=\"DROPDOWN_03_RACE_8CFA38D416E34DE08E2EC88A3E334503_DROPDOWN_04\" CodedValue=\"C92\">\n\t\t\t\t\t<Decode>\n\t\t\t\t\t\t<TranslatedText>Caucasian</TranslatedText>\n\t\t\t\t\t</Decode>\n\t\t\t\t</CodeListItem>\n\t\t\t\t<CodeListItem co:SelectionOID=\"DROPDOWN_03_RACE_8CFA38D416E34DE08E2EC88A3E334503_DROPDOWN_05\" CodedValue=\"C93\">\n\t\t\t\t\t<Decode>\n\t\t\t\t\t\t<TranslatedText>Pacific Islander</TranslatedText>\n\t\t\t\t\t</Decode>\n\t\t\t\t</CodeListItem>\n\t\t\t</CodeList>\n\t\t\t<CodeList OID=\"AssociationAction\" Name=\"AssociationAction\" DataType=\"text\">\n\t\t\t\t<CodeListItem co:SelectionOID=\"AssociationAction.Created\" CodedValue=\"Created\">\n\t\t\t\t\t<Decode>\n\t\t\t\t\t\t<TranslatedText>Created</TranslatedText>\n\t\t\t\t\t</Decode>\n\t\t\t\t</CodeListItem>\n\t\t\t\t<CodeListItem co:SelectionOID=\"AssociationAction.Removed\" CodedValue=\"Removed\">\n\t\t\t\t\t<Decode>\n\t\t\t\t\t\t<TranslatedText>Removed</TranslatedText>\n\t\t\t\t\t</Decode>\n\t\t\t\t</CodeListItem>\n\t\t\t</CodeList>\n\t\t\t<CodeList OID=\"FlagType\" Name=\"FlagType\" DataType=\"text\">\n\t\t\t\t<CodeListItem co:SelectionOID=\"FlagType.Association\" CodedValue=\"Association\">\n\t\t\t\t\t<Decode>\n\t\t\t\t\t\t<TranslatedText>Association</TranslatedText>\n\t\t\t\t\t</Decode>\n\t\t\t\t</CodeListItem>\n\t\t\t</CodeList>\n\t\t</MetaDataVersion>\n\t</Study>\n</ODM>",
    "xml":{
        "name":"ODM"
    }
}

Example:

<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="T15" FileType="Transactional" FileOID="oracle/T15/BF400E2655C4493799A17C7B947557F0" CreationDateTime="2025-11-03T18:14:02.559Z" ODMVersion="1.3.2" Originator="system" SourceSystem="Oracle Life Sciences Clinical One" SourceSystemVersion="MetaData API v10.0" co:studyMode="test" co:includeCOExtensions="true" co:fromTimestamp="2024-01-01T00:00:00Z" co:studyVersion="1.0.0.3" co:studyVersionSummary="false" co:hasMore="false" co:totalResults="1" co:count="1" co:limit="1" co:offset="0">
	<Study OID="T15" co:SafetyIntegrationEnabled="false">
		<GlobalVariables>
			<StudyName>T15</StudyName>
			<StudyDescription>Test15</StudyDescription>
			<ProtocolName>T15</ProtocolName>
		</GlobalVariables>
		<BasicDefinitions>
			<MeasurementUnit OID="kg/m2" Name="kg/m2">
				<Symbol>
					<TranslatedText>kg/m2</TranslatedText>
				</Symbol>
			</MeasurementUnit>
			<MeasurementUnit OID="Years" Name="Years">
				<Symbol>
					<TranslatedText>Years</TranslatedText>
				</Symbol>
			</MeasurementUnit>
		</BasicDefinitions>
		<MetaDataVersion co:StudyWid="582" co:GUID="FE9ABAA632634DFA84D1863365689C42" co:VersionStart="2023-06-08T10:54:02.478Z" OID="T15v1.0.0.1" Name="T15">
			<Protocol>
				<StudyEventRef StudyEventOID="AE_517E14D0AC2C4319B16D57B54F42CD28" OrderNumber="1" Mandatory="No"></StudyEventRef>
				<StudyEventRef StudyEventOID="SV01_32781214B9394105AC61CDE66D28E8D4" OrderNumber="2" Mandatory="Yes"></StudyEventRef>
				<StudyEventRef StudyEventOID="BV01_944101E4D1ED4DC8B04D81670969D5B0" OrderNumber="3" Mandatory="Yes"></StudyEventRef>
			</Protocol>
			<StudyEventDef co:StudyEventWid="1557" co:GUID="517E14D0AC2C4319B16D57B54F42CD28" co:VersionStart="2023-06-08T10:54:04.642Z" OID="AE_517E14D0AC2C4319B16D57B54F42CD28" Name="ADVERSEEVENT" Repeating="No" Type="Unscheduled" Category="AdverseEvent" co:AlertOutsideVisitWindow="off"></StudyEventDef>
			<StudyEventDef co:StudyEventWid="1559" co:GUID="32781214B9394105AC61CDE66D28E8D4" co:VersionStart="2023-06-14T16:50:55.978Z" co:DelayDays="0" co:DelayHours="0" co:DelayWindowBeforeDays="0" co:DelayWindowBeforeHours="0" co:DelayWindowAfterDays="0" co:DelayWindowAfterHours="0" co:DelayWindowHardStop="0" co:DelayWindowVisitApproval="0" OID="SV01_32781214B9394105AC61CDE66D28E8D4" Name="SCREENINGVISIT" Repeating="No" Type="Scheduled" Category="ScreeningVisit" co:AlertOutsideVisitWindow="off">
				<FormRef FormOID="FORM_01_9EF4AB0095C646638639BE29015BE12B" OrderNumber="1" Mandatory="Yes"></FormRef>
			</StudyEventDef>
			<StudyEventDef co:StudyEventWid="1558" co:GUID="944101E4D1ED4DC8B04D81670969D5B0" co:VersionStart="2023-06-14T16:51:40.385Z" co:DelayDays="1" co:DelayHours="0" co:DelayWindowBeforeDays="0" co:DelayWindowBeforeHours="0" co:DelayWindowAfterDays="0" co:DelayWindowAfterHours="0" OID="BV01_944101E4D1ED4DC8B04D81670969D5B0" Name="BASELINEVISIT" Repeating="No" Type="Scheduled" Category="ScheduleAbleVisit">
				<FormRef FormOID="FORM_02_C7A1E7351E7C4E8EB047E76CB5B20AFB" OrderNumber="1" Mandatory="Yes"></FormRef>
			</StudyEventDef>
			<FormDef OID="FORM_01_9EF4AB0095C646638639BE29015BE12B" Name="ScreeningForm" Repeating="No">
				<ItemGroupRef OrderNumber="1" Mandatory="Yes" ItemGroupOID="IG_DATETIME_01_F908F5EB04CB48D9999F9253E90AC0E0"></ItemGroupRef>
				<ItemGroupRef OrderNumber="2" Mandatory="Yes" ItemGroupOID="IG_RADIOSET_01_39B1292322524D08ACD5102CD149EA54"></ItemGroupRef>
				<ItemGroupRef OrderNumber="3" Mandatory="Yes" ItemGroupOID="IG_SMARTITEM_01_AGE_629460FD54724C588E81A9E8F45C88D7"></ItemGroupRef>
				<ItemGroupRef OrderNumber="4" Mandatory="Yes" ItemGroupOID="IG_SMARTITEM_02_DOB_4E18C108F99242EF92D2EF97C32FF439"></ItemGroupRef>
				<ItemGroupRef OrderNumber="5" Mandatory="Yes" ItemGroupOID="IG_CHECKBOX_01_CAD07B7C05BB4A00B152847CC3D046CD"></ItemGroupRef>
				<ItemGroupRef OrderNumber="6" Mandatory="Yes" ItemGroupOID="IG_DROPDOWN_03_EB54E6654075424C802062CDA1F05679"></ItemGroupRef>
				<ItemGroupRef OrderNumber="7" Mandatory="Yes" ItemGroupOID="IG_RADIOSET_04_A0B7DDDDABDD413C8ADE7E4A956E8181"></ItemGroupRef>
				<ItemGroupRef OrderNumber="8" Mandatory="No" ItemGroupOID="IG_TEXT_34_8D6DCDCC63964661BB25E40319A310D3"></ItemGroupRef>
				<ItemGroupRef OrderNumber="9" Mandatory="Yes" ItemGroupOID="IG_NUMBER_04_0F473394D64C420DACDBD90F7819489A"></ItemGroupRef>
				<ItemGroupRef OrderNumber="10" Mandatory="Yes" ItemGroupOID="IG_TEXT_35_6A91A1AE09E14A979D5840A16D0FC8D5"></ItemGroupRef>
			</FormDef>
			<FormDef OID="FORM_02_C7A1E7351E7C4E8EB047E76CB5B20AFB" Name="ConMed Form" Repeating="Yes">
				<ItemGroupRef OrderNumber="1" Mandatory="Yes" ItemGroupOID="IG_TEXT_01_876B1FFEB83242D1919462E349E08463"></ItemGroupRef>
				<ItemGroupRef OrderNumber="2" Mandatory="Yes" ItemGroupOID="IG_DATETIME_02_4BA5316F99404220A8EC0E2EC856A642"></ItemGroupRef>
				<ItemGroupRef OrderNumber="3" Mandatory="Yes" ItemGroupOID="IG_TEXT_03_0654B2AF1E2C4FE9912098CC89B7E0A0"></ItemGroupRef>
				<ItemGroupRef OrderNumber="4" Mandatory="Yes" ItemGroupOID="IG_TEXT_04_0B7FA31FB3DC418D97C729EE55E1065A"></ItemGroupRef>
				<ItemGroupRef OrderNumber="5" Mandatory="Yes" ItemGroupOID="IG_NUMBER_01_2BB97DE583734CB2A03D35F2DC694312"></ItemGroupRef>
				<ItemGroupRef OrderNumber="6" Mandatory="No" ItemGroupOID="IG_TEXT_33_465DE0BE9D5F41A5A1D69CC7F1F2674A"></ItemGroupRef>
			</FormDef>
			<ItemGroupDef OID="IG_TEXT_01_876B1FFEB83242D1919462E349E08463" Name="Procedure Name" Repeating="No">
				<ItemRef OrderNumber="1" Mandatory="Yes" ItemOID="TEXT_01_876B1FFEB83242D1919462E349E08463"></ItemRef>
			</ItemGroupDef>
			<ItemGroupDef OID="IG_DATETIME_02_4BA5316F99404220A8EC0E2EC856A642" Name="Date Of Procedure" Repeating="No">
				<ItemRef OrderNumber="1" Mandatory="Yes" ItemOID="DATETIME_02_4BA5316F99404220A8EC0E2EC856A642"></ItemRef>
			</ItemGroupDef>
			<ItemGroupDef OID="IG_TEXT_03_0654B2AF1E2C4FE9912098CC89B7E0A0" Name="Reason For Procedure" Repeating="No">
				<ItemRef OrderNumber="1" Mandatory="Yes" ItemOID="TEXT_03_0654B2AF1E2C4FE9912098CC89B7E0A0"></ItemRef>
			</ItemGroupDef>
			<ItemGroupDef OID="IG_TEXT_04_0B7FA31FB3DC418D97C729EE55E1065A" Name="Dose Recommended" Repeating="No">
				<ItemRef OrderNumber="1" Mandatory="Yes" ItemOID="TEXT_04_0B7FA31FB3DC418D97C729EE55E1065A"></ItemRef>
			</ItemGroupDef>
			<ItemGroupDef OID="IG_NUMBER_01_2BB97DE583734CB2A03D35F2DC694312" Name="Dose Units" Repeating="No">
				<ItemRef OrderNumber="1" Mandatory="Yes" ItemOID="NUMBER_01_2BB97DE583734CB2A03D35F2DC694312"></ItemRef>
			</ItemGroupDef>
			<ItemGroupDef OID="IG_TEXT_33_465DE0BE9D5F41A5A1D69CC7F1F2674A" Name="Dose Period" Repeating="No">
				<ItemRef OrderNumber="1" Mandatory="No" ItemOID="TEXT_33_465DE0BE9D5F41A5A1D69CC7F1F2674A"></ItemRef>
			</ItemGroupDef>
			<ItemGroupDef OID="IG_DATETIME_01_F908F5EB04CB48D9999F9253E90AC0E0" Name="Screening date" Repeating="No">
				<ItemRef OrderNumber="1" Mandatory="Yes" ItemOID="DATETIME_01_F908F5EB04CB48D9999F9253E90AC0E0"></ItemRef>
			</ItemGroupDef>
			<ItemGroupDef OID="IG_RADIOSET_01_39B1292322524D08ACD5102CD149EA54" Name="Gender" Repeating="No">
				<ItemRef OrderNumber="1" Mandatory="Yes" ItemOID="RADIOSET_01_39B1292322524D08ACD5102CD149EA54"></ItemRef>
			</ItemGroupDef>
			<ItemGroupDef OID="IG_SMARTITEM_01_AGE_629460FD54724C588E81A9E8F45C88D7" Name="Age" Repeating="No">
				<ItemRef OrderNumber="1" Mandatory="Yes" ItemOID="SMARTITEM_01_AGE_629460FD54724C588E81A9E8F45C88D7"></ItemRef>
			</ItemGroupDef>
			<ItemGroupDef OID="IG_SMARTITEM_02_DOB_4E18C108F99242EF92D2EF97C32FF439" Name="Age_SMARTITEM_02_DOB" Repeating="No">
				<ItemRef OrderNumber="1" Mandatory="Yes" ItemOID="SMARTITEM_02_DOB_4E18C108F99242EF92D2EF97C32FF439"></ItemRef>
			</ItemGroupDef>
			<ItemGroupDef OID="IG_CHECKBOX_01_CAD07B7C05BB4A00B152847CC3D046CD" Name="Fasting" Repeating="No">
				<ItemRef OrderNumber="1" Mandatory="Yes" ItemOID="CHECKBOX_01_CAD07B7C05BB4A00B152847CC3D046CD"></ItemRef>
			</ItemGroupDef>
			<ItemGroupDef OID="IG_DROPDOWN_03_EB54E6654075424C802062CDA1F05679" Name="Race" Repeating="No">
				<ItemRef OrderNumber="1" Mandatory="Yes" ItemOID="DROPDOWN_03_EB54E6654075424C802062CDA1F05679"></ItemRef>
			</ItemGroupDef>
			<ItemGroupDef OID="IG_RADIOSET_04_A0B7DDDDABDD413C8ADE7E4A956E8181" Name="Is RollOver Question?" Repeating="No">
				<ItemRef OrderNumber="1" Mandatory="Yes" ItemOID="RADIOSET_04_A0B7DDDDABDD413C8ADE7E4A956E8181"></ItemRef>
			</ItemGroupDef>
			<ItemGroupDef OID="IG_TEXT_34_8D6DCDCC63964661BB25E40319A310D3" Name="Screening Initials" Repeating="No">
				<ItemRef OrderNumber="1" Mandatory="No" ItemOID="TEXT_34_8D6DCDCC63964661BB25E40319A310D3"></ItemRef>
			</ItemGroupDef>
			<ItemGroupDef OID="IG_NUMBER_04_0F473394D64C420DACDBD90F7819489A" Name="Body Mass Index(BMI)" Repeating="No">
				<ItemRef OrderNumber="1" Mandatory="Yes" ItemOID="NUMBER_04_0F473394D64C420DACDBD90F7819489A"></ItemRef>
			</ItemGroupDef>
			<ItemGroupDef OID="IG_TEXT_35_6A91A1AE09E14A979D5840A16D0FC8D5" Name="Symptoms" Repeating="No">
				<ItemRef OrderNumber="1" Mandatory="Yes" ItemOID="TEXT_35_6A91A1AE09E14A979D5840A16D0FC8D5"></ItemRef>
			</ItemGroupDef>
			<ItemDef co:ItemWid="6373" co:GUID="876B1FFEB83242D1919462E349E08463" co:ItemVersionStart="2023-06-14T16:28:31.523Z" co:Precision="0" co:AllowFutureDate="No" OID="TEXT_01_876B1FFEB83242D1919462E349E08463" Name="TEXT_01" DataType="string" Length="4000">
				<Question>
					<TranslatedText>Procedure Name</TranslatedText>
				</Question>
			</ItemDef>
			<ItemDef co:ItemWid="6372" co:GUID="4BA5316F99404220A8EC0E2EC856A642" co:ItemVersionStart="2023-06-14T16:28:31.517Z" co:Precision="0" co:AllowFutureDate="No" OID="DATETIME_02_4BA5316F99404220A8EC0E2EC856A642" Name="DATETIME_02" DataType="date">
				<Question>
					<TranslatedText>Date Of Procedure</TranslatedText>
				</Question>
			</ItemDef>
			<ItemDef co:ItemWid="6381" co:GUID="0654B2AF1E2C4FE9912098CC89B7E0A0" co:ItemVersionStart="2023-06-14T16:28:31.515Z" co:Precision="0" co:AllowFutureDate="No" OID="TEXT_03_0654B2AF1E2C4FE9912098CC89B7E0A0" Name="TEXT_03" DataType="string" Length="4000">
				<Question>
					<TranslatedText>Reason For Procedure</TranslatedText>
				</Question>
			</ItemDef>
			<ItemDef co:ItemWid="6369" co:GUID="0B7FA31FB3DC418D97C729EE55E1065A" co:ItemVersionStart="2023-06-14T16:28:31.510Z" co:Precision="0" co:AllowFutureDate="No" OID="TEXT_04_0B7FA31FB3DC418D97C729EE55E1065A" Name="TEXT_04" DataType="string" Length="4000">
				<Question>
					<TranslatedText>Dose Recommended</TranslatedText>
				</Question>
			</ItemDef>
			<ItemDef co:ItemWid="6370" co:GUID="2BB97DE583734CB2A03D35F2DC694312" co:ItemVersionStart="2023-06-14T16:28:31.450Z" co:Precision="0" co:AllowFutureDate="No" OID="NUMBER_01_2BB97DE583734CB2A03D35F2DC694312" Name="NUMBER_01" DataType="integer">
				<Question>
					<TranslatedText>Dose Units</TranslatedText>
				</Question>
			</ItemDef>
			<ItemDef co:ItemWid="6368" co:GUID="465DE0BE9D5F41A5A1D69CC7F1F2674A" co:ItemVersionStart="2023-06-14T16:47:12.375Z" co:Precision="0" co:AllowFutureDate="No" OID="TEXT_33_465DE0BE9D5F41A5A1D69CC7F1F2674A" Name="TEXT_33" DataType="string" Length="4000">
				<Question>
					<TranslatedText>Dose Period</TranslatedText>
				</Question>
			</ItemDef>
			<ItemDef co:ItemWid="6378" co:GUID="F908F5EB04CB48D9999F9253E90AC0E0" co:ItemVersionStart="2023-06-14T16:47:59.124Z" co:Precision="0" co:AllowFutureDate="No" OID="DATETIME_01_F908F5EB04CB48D9999F9253E90AC0E0" Name="DATETIME_01" DataType="date">
				<Question>
					<TranslatedText>Screening date</TranslatedText>
				</Question>
			</ItemDef>
			<ItemDef co:ItemWid="6367" co:GUID="39B1292322524D08ACD5102CD149EA54" co:ItemVersionStart="2023-06-14T16:50:02.321Z" co:Precision="1" co:AllowFutureDate="No" OID="RADIOSET_01_39B1292322524D08ACD5102CD149EA54" Name="RADIOSET_01" DataType="string">
				<Question>
					<TranslatedText>Gender</TranslatedText>
				</Question>
				<CodeListRef CodeListOID="RADIOSET_01_GENDER_E0DF1B7FD6B34ABCB134AEA77F5C82E1"></CodeListRef>
			</ItemDef>
			<ItemDef co:ItemWid="6379" co:GUID="629460FD54724C588E81A9E8F45C88D7" co:ItemVersionStart="2023-06-14T16:50:02.360Z" co:Precision="0" co:AllowFutureDate="No" co:DataClassification='Sponsor Data' OID="SMARTITEM_01_AGE_629460FD54724C588E81A9E8F45C88D7" Name="SMARTITEM_01_AGE" DataType="integer">
				<Question>
					<TranslatedText>Age</TranslatedText>
				</Question>
				<MeasurementUnitRef MeasurementUnitOID="Years"></MeasurementUnitRef>
			</ItemDef>
			<ItemDef co:ItemWid="6375" co:GUID="4E18C108F99242EF92D2EF97C32FF439" co:ItemVersionStart="2023-06-14T16:50:02.404Z" co:Precision="0" co:AllowFutureDate="No" co:DataClassification='Sponsor Data' OID="SMARTITEM_02_DOB_4E18C108F99242EF92D2EF97C32FF439" Name="SMARTITEM_02_DOB" DataType="date">
				<Question>
					<TranslatedText>Age_SMARTITEM_02_DOB</TranslatedText>
				</Question>
			</ItemDef>
			<ItemDef co:ItemWid="6371" co:GUID="CAD07B7C05BB4A00B152847CC3D046CD" co:ItemVersionStart="2023-06-14T16:47:59.131Z" co:Precision="1" co:AllowFutureDate="No" co:CodelistLinkType="STATIC" OID="CHECKBOX_01_CAD07B7C05BB4A00B152847CC3D046CD" Name="CHECKBOX_01" DataType="string">
				<Question>
					<TranslatedText>Fasting</TranslatedText>
				</Question>
				<CodeListRef CodeListOID="CHECKBOX_01_FASTING_380D34D8478D45C9B72ED700A294D05F"></CodeListRef>
			</ItemDef>
			<ItemDef co:ItemWid="6376" co:GUID="EB54E6654075424C802062CDA1F05679" co:ItemVersionStart="2023-06-14T16:50:02.489Z" co:Precision="1" co:AllowFutureDate="No" co:CodelistLinkType="STATIC" OID="DROPDOWN_03_EB54E6654075424C802062CDA1F05679" Name="DROPDOWN_03" DataType="string">
				<Question>
					<TranslatedText>Race</TranslatedText>
				</Question>
				<CodeListRef CodeListOID="DROPDOWN_03_RACE_8CFA38D416E34DE08E2EC88A3E334503"></CodeListRef>
			</ItemDef>
			<ItemDef co:ItemWid="6374" co:GUID="A0B7DDDDABDD413C8ADE7E4A956E8181" co:ItemVersionStart="2023-06-14T16:50:02.542Z" co:Precision="1" co:AllowFutureDate="No" co:CodelistLinkType="DYNAMIC" OID="RADIOSET_04_A0B7DDDDABDD413C8ADE7E4A956E8181" Name="RADIOSET_04" DataType="string">
				<Question>
					<TranslatedText>Is RollOver Question?</TranslatedText>
				</Question>
				<CodeListRef CodeListOID="RADIOSET_04_FASTING_4F9EE6A9C16049B69F0023A632C0CD19"></CodeListRef>
			</ItemDef>
			<ItemDef co:ItemWid="6380" co:GUID="8D6DCDCC63964661BB25E40319A310D3" co:ItemVersionStart="2023-06-14T16:47:59.115Z" co:Precision="0" co:AllowFutureDate="No" OID="TEXT_34_8D6DCDCC63964661BB25E40319A310D3" Name="TEXT_34" DataType="string" Length="4000">
				<Question>
					<TranslatedText>Screening Initials</TranslatedText>
				</Question>
			</ItemDef>
			<ItemDef co:ItemWid="6377" co:GUID="0F473394D64C420DACDBD90F7819489A" co:ItemVersionStart="2023-06-14T16:47:59.126Z" co:Precision="1" co:AllowFutureDate="No" OID="NUMBER_04_0F473394D64C420DACDBD90F7819489A" Name="NUMBER_04" DataType="float">
				<Question>
					<TranslatedText>Body Mass Index(BMI)</TranslatedText>
				</Question>
				<MeasurementUnitRef MeasurementUnitOID="kg/m2"></MeasurementUnitRef>
			</ItemDef>
			<ItemDef co:ItemWid="6430" co:GUID="6A91A1AE09E14A979D5840A16D0FC8D5" co:ItemVersionStart="2024-04-23T11:45:54.330Z" co:Precision="0" co:AllowFutureDate="No" OID="TEXT_35_6A91A1AE09E14A979D5840A16D0FC8D5" Name="TEXT_35" DataType="string" Length="4000">
				<Question>
					<TranslatedText>Symptoms</TranslatedText>
				</Question>
			</ItemDef>
			<CodeList OID="RADIOSET_01_GENDER_E0DF1B7FD6B34ABCB134AEA77F5C82E1" Name="Gender" DataType="string">
				<CodeListItem co:SelectionOID="RADIOSET_01_GENDER_E0DF1B7FD6B34ABCB134AEA77F5C82E1_RADIOSET_01" CodedValue="C45">
					<Decode>
						<TranslatedText>Male</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem co:SelectionOID="RADIOSET_01_GENDER_E0DF1B7FD6B34ABCB134AEA77F5C82E1_RADIOSET_02" CodedValue="C46">
					<Decode>
						<TranslatedText>Female</TranslatedText>
					</Decode>
				</CodeListItem>
			</CodeList>
			<CodeList OID="CHECKBOX_01_FASTING_380D34D8478D45C9B72ED700A294D05F" Name="Fasting" DataType="string">
				<CodeListItem co:SelectionOID="CHECKBOX_01_FASTING_380D34D8478D45C9B72ED700A294D05F_CHECKBOX_01" CodedValue="C10">
					<Decode>
						<TranslatedText>Yes</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem co:SelectionOID="CHECKBOX_01_FASTING_380D34D8478D45C9B72ED700A294D05F_CHECKBOX_02" CodedValue="C11">
					<Decode>
						<TranslatedText>No</TranslatedText>
					</Decode>
				</CodeListItem>
			</CodeList>
			<CodeList OID="RADIOSET_04_FASTING_4F9EE6A9C16049B69F0023A632C0CD19" Name="Fasting" DataType="string">
				<CodeListItem co:SelectionOID="RADIOSET_04_FASTING_4F9EE6A9C16049B69F0023A632C0CD19_RADIOSET_01" CodedValue="C10">
					<Decode>
						<TranslatedText>Yes</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem co:SelectionOID="RADIOSET_04_FASTING_4F9EE6A9C16049B69F0023A632C0CD19_RADIOSET_02" CodedValue="C11">
					<Decode>
						<TranslatedText>No</TranslatedText>
					</Decode>
				</CodeListItem>
			</CodeList>
			<CodeList OID="DROPDOWN_03_RACE_8CFA38D416E34DE08E2EC88A3E334503" Name="Race" DataType="string">
				<CodeListItem co:SelectionOID="DROPDOWN_03_RACE_8CFA38D416E34DE08E2EC88A3E334503_DROPDOWN_01" CodedValue="C89">
					<Decode>
						<TranslatedText>African American</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem co:SelectionOID="DROPDOWN_03_RACE_8CFA38D416E34DE08E2EC88A3E334503_DROPDOWN_02" CodedValue="C90">
					<Decode>
						<TranslatedText>American Indian</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem co:SelectionOID="DROPDOWN_03_RACE_8CFA38D416E34DE08E2EC88A3E334503_DROPDOWN_03" CodedValue="C91">
					<Decode>
						<TranslatedText>Asian</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem co:SelectionOID="DROPDOWN_03_RACE_8CFA38D416E34DE08E2EC88A3E334503_DROPDOWN_04" CodedValue="C92">
					<Decode>
						<TranslatedText>Caucasian</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem co:SelectionOID="DROPDOWN_03_RACE_8CFA38D416E34DE08E2EC88A3E334503_DROPDOWN_05" CodedValue="C93">
					<Decode>
						<TranslatedText>Pacific Islander</TranslatedText>
					</Decode>
				</CodeListItem>
			</CodeList>
			<CodeList OID="AssociationAction" Name="AssociationAction" DataType="text">
				<CodeListItem co:SelectionOID="AssociationAction.Created" CodedValue="Created">
					<Decode>
						<TranslatedText>Created</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem co:SelectionOID="AssociationAction.Removed" CodedValue="Removed">
					<Decode>
						<TranslatedText>Removed</TranslatedText>
					</Decode>
				</CodeListItem>
			</CodeList>
			<CodeList OID="FlagType" Name="FlagType" DataType="text">
				<CodeListItem co:SelectionOID="FlagType.Association" CodedValue="Association">
					<Decode>
						<TranslatedText>Association</TranslatedText>
					</Decode>
				</CodeListItem>
			</CodeList>
		</MetaDataVersion>
	</Study>
</ODM>

Nested Schema : Study

Type: array

List of ODM Study elements.

Show Source

• Array of: object Study
  ODM Study container with global variables, optional basic definitions and one or more metadata versions describing the study structure.

{
    "type":"array",
    "description":"List of ODM Study elements.",
    "example":[
    ],
    "xml":{
        "name":"Study"
    },
    "items":{
        "$ref":"#/components/schemas/Study"
    }
}

Nested Schema : Study

Type: object

ODM Study container with global variables, optional basic definitions and one or more metadata versions describing the study structure.

Show Source

• basicDefinitions: object BasicDefinitions
  Collection of units of measurement defined for this study.
• globalVariables(required): object GlobalVariables
  Global attributes of a study including human readable name, description and protocol identifier.
• metaDataVersion: array metaDataVersion
  One or more metadata versions that define the study design and data structures.
• oid: string
  Unique identifier for the Study within ODM context.

  Example: S_0001
• safetyIntegrationEnabled: string
  Indicates if Safety integration is enabled for this study. Values may be true or false.

  Example: true

{
    "required":[
        "globalVariables"
    ],
    "type":"object",
    "properties":{
        "globalVariables":{
            "$ref":"#/components/schemas/GlobalVariables"
        },
        "basicDefinitions":{
            "$ref":"#/components/schemas/BasicDefinitions"
        },
        "metaDataVersion":{
            "type":"array",
            "description":"One or more metadata versions that define the study design and data structures.",
            "items":{
                "$ref":"#/components/schemas/MetaDataVersion"
            }
        },
        "oid":{
            "type":"string",
            "description":"Unique identifier for the Study within ODM context.",
            "example":"S_0001",
            "xml":{
                "name":"OID",
                "attribute":true
            }
        },
        "safetyIntegrationEnabled":{
            "type":"string",
            "description":"Indicates if Safety integration is enabled for this study. Values may be true or false.",
            "example":"true",
            "xml":{
                "name":"SafetyIntegrationEnabled",
                "namespace":"https://docs.oracle.com/en/industries/life-sciences/clinical-one/odm/extensions/v1",
                "attribute":true
            }
        }
    },
    "description":"ODM Study container with global variables, optional basic definitions and one or more metadata versions describing the study structure.",
    "example":[
    ]
}

Nested Schema : BasicDefinitions

Type: object

Collection of units of measurement defined for this study.

Show Source

• measurementUnit: array MeasurementUnit
  Units of measurement defined for this study.

{
    "type":"object",
    "properties":{
        "measurementUnit":{
            "type":"array",
            "description":"Units of measurement defined for this study.",
            "xml":{
                "name":"MeasurementUnit"
            },
            "items":{
                "$ref":"#/components/schemas/MeasurementUnit"
            }
        }
    },
    "description":"Collection of units of measurement defined for this study."
}

Nested Schema : GlobalVariables

Type: object

Global attributes of a study including human readable name, description and protocol identifier.

Show Source

• protocolName(required): object ProtocolName
  Protocol identifier or shorthand title container.
• studyDescription(required): object StudyDescription
  Description of the study.
• studyName(required): object StudyName
  Official study name.

{
    "required":[
        "protocolName",
        "studyDescription",
        "studyName"
    ],
    "type":"object",
    "properties":{
        "studyName":{
            "$ref":"#/components/schemas/StudyName"
        },
        "studyDescription":{
            "$ref":"#/components/schemas/StudyDescription"
        },
        "protocolName":{
            "$ref":"#/components/schemas/ProtocolName"
        }
    },
    "description":"Global attributes of a study including human readable name, description and protocol identifier.",
    "example":"<GlobalVariables><StudyName>STUDY01</StudyName><StudyDescription>Study01</StudyDescription><ProtocolName>STUDY01</ProtocolName></GlobalVariables>"
}

Example:

<GlobalVariables><StudyName>STUDY01</StudyName><StudyDescription>Study01</StudyDescription><ProtocolName>STUDY01</ProtocolName></GlobalVariables>

Nested Schema : metaDataVersion

Type: array

One or more metadata versions that define the study design and data structures.

Show Source

• Array of: object MetaDataVersion
  Defines the study design and data structures including events, forms, items, code lists and methods.

{
    "type":"array",
    "description":"One or more metadata versions that define the study design and data structures.",
    "items":{
        "$ref":"#/components/schemas/MetaDataVersion"
    }
}

Nested Schema : MeasurementUnit

Type: array

Units of measurement defined for this study.

Show Source

• Array of: object MeasurementUnit
  Definition of a measurement unit including symbol and optional aliases.

{
    "type":"array",
    "description":"Units of measurement defined for this study.",
    "xml":{
        "name":"MeasurementUnit"
    },
    "items":{
        "$ref":"#/components/schemas/MeasurementUnit"
    }
}

Nested Schema : MeasurementUnit

Type: object

Definition of a measurement unit including symbol and optional aliases.

Show Source

• alias: array Alias
  Zero or more aliases for this unit.
• name: string
  Human friendly name of the unit.

  Example: mg
• oid: string
  Unique identifier for the measurement unit within ODM context.

  Example: mg
• symbol(required): object Symbol
  Symbol for a measurement unit represented as a list of translated text entries.

{
    "required":[
        "symbol"
    ],
    "type":"object",
    "properties":{
        "symbol":{
            "$ref":"#/components/schemas/Symbol"
        },
        "alias":{
            "type":"array",
            "description":"Zero or more aliases for this unit.",
            "xml":{
                "name":"Alias"
            },
            "items":{
                "$ref":"#/components/schemas/Alias"
            }
        },
        "oid":{
            "type":"string",
            "description":"Unique identifier for the measurement unit within ODM context.",
            "example":"mg",
            "xml":{
                "name":"OID",
                "attribute":true
            }
        },
        "name":{
            "type":"string",
            "description":"Human friendly name of the unit.",
            "example":"mg",
            "xml":{
                "name":"Name",
                "attribute":true
            }
        }
    },
    "description":"Definition of a measurement unit including symbol and optional aliases.",
    "example":"<MeasurementUnit OID=\"mg\" Name=\"mg\"><Symbol><TranslatedText>mg</TranslatedText></Symbol></MeasurementUnit>"
}

Example:

<MeasurementUnit OID="mg" Name="mg"><Symbol><TranslatedText>mg</TranslatedText></Symbol></MeasurementUnit>

Nested Schema : Alias

Type: array

Zero or more aliases for this unit.

Show Source

• Array of: object Alias
  Alternative naming context and value for an ODM element.

{
    "type":"array",
    "description":"Zero or more aliases for this unit.",
    "xml":{
        "name":"Alias"
    },
    "items":{
        "$ref":"#/components/schemas/Alias"
    }
}

Nested Schema : Symbol

Type: object

Symbol for a measurement unit represented as a list of translated text entries.

Show Source

• translatedText(required): array TranslatedText
  Translated symbol values with language codes.

{
    "required":[
        "translatedText"
    ],
    "type":"object",
    "properties":{
        "translatedText":{
            "type":"array",
            "description":"Translated symbol values with language codes.",
            "xml":{
                "name":"TranslatedText"
            },
            "items":{
                "$ref":"#/components/schemas/TranslatedText"
            }
        }
    },
    "description":"Symbol for a measurement unit represented as a list of translated text entries.",
    "example":"<Symbol><TranslatedText>mg</TranslatedText></Symbol>"
}

Example:

<Symbol><TranslatedText>mg</TranslatedText></Symbol>

Nested Schema : Alias

Type: object

Alternative naming context and value for an ODM element.

Show Source

• context: string
  Naming context for the alias.

  Example: CDISC
• name: string
  Alias value within the given context.

  Example: MG

{
    "type":"object",
    "properties":{
        "context":{
            "type":"string",
            "description":"Naming context for the alias.",
            "example":"CDISC",
            "xml":{
                "name":"Context",
                "attribute":true
            }
        },
        "name":{
            "type":"string",
            "description":"Alias value within the given context.",
            "example":"MG",
            "xml":{
                "name":"Name",
                "attribute":true
            }
        }
    },
    "description":"Alternative naming context and value for an ODM element.",
    "example":"<Alias Context=\"CDISC\" Name=\"MG\"/>"
}

Example:

<Alias Context="CDISC" Name="MG"/>

Nested Schema : TranslatedText

Type: array

Translated symbol values with language codes.

Show Source

• Array of: object TranslatedText
  Localized text value with associated language code.

{
    "type":"array",
    "description":"Translated symbol values with language codes.",
    "xml":{
        "name":"TranslatedText"
    },
    "items":{
        "$ref":"#/components/schemas/TranslatedText"
    }
}

Nested Schema : TranslatedText

Type: object

Localized text value with associated language code.

Show Source

• lang: string
  BCP 47 language code for the text value.

  Example: en
• value: string
  Text value.

  Example: mg

{
    "type":"object",
    "properties":{
        "value":{
            "type":"string",
            "description":"Text value.",
            "example":"mg"
        },
        "lang":{
            "type":"string",
            "description":"BCP 47 language code for the text value.",
            "example":"en",
            "xml":{
                "namespace":"http://www.w3.org/XML/1998/namespace",
                "attribute":true
            }
        }
    },
    "description":"Localized text value with associated language code.",
    "example":"<TranslatedText>mg</TranslatedText>"
}

Example:

<TranslatedText>mg</TranslatedText>

Nested Schema : ProtocolName

Type: object

Protocol identifier or shorthand title container.

Show Source

• value: string
  Protocol identifier or shorthand title.

  Example: STUDY01

{
    "type":"object",
    "properties":{
        "value":{
            "type":"string",
            "description":"Protocol identifier or shorthand title.",
            "example":"STUDY01"
        }
    },
    "description":"Protocol identifier or shorthand title container.",
    "example":"<ProtocolName>STUDY01</ProtocolName>"
}

Example:

<ProtocolName>STUDY01</ProtocolName>

Nested Schema : StudyDescription

Type: object

Description of the study.

Show Source

• value: string
  Free text description content.

  Example: Randomized double-blind trial across 25 sites

{
    "type":"object",
    "properties":{
        "value":{
            "type":"string",
            "description":"Free text description content.",
            "example":"Randomized double-blind trial across 25 sites"
        }
    },
    "description":"Description of the study.",
    "example":"<StudyDescription>Randomized double-blind trial across 25 sites</StudyDescription>"
}

Example:

<StudyDescription>Randomized double-blind trial across 25 sites</StudyDescription>

Nested Schema : StudyName

Type: object

Official study name.

Show Source

• value: string
  Human readable study name.

  Example: STUDY01

{
    "type":"object",
    "properties":{
        "value":{
            "type":"string",
            "description":"Human readable study name.",
            "example":"STUDY01"
        }
    },
    "description":"Official study name.",
    "example":"<StudyName>STUDY01</StudyName>"
}

Example:

<StudyName>STUDY01</StudyName>

Nested Schema : MetaDataVersion

Type: object

Defines the study design and data structures including events, forms, items, code lists and methods.

Show Source

• codeList: array CodeList
  Code lists used by item definitions.
• conditionDef: array ConditionDef
  Conditional logic definitions used in the study.
• description: string
  Optional description for this metadata version.

  Example: Initial metadata version
• formDef: array formDef
  Form definitions contained in events.
• imputationMethod: array ImputationMethod
  Imputation methods available to handle missing data.
• include: object Include
  Reference to another study and metadata version within ODM.
• itemDef: array itemDef
  Item definitions used across the study.
• itemGroupDef: array itemGroupDef
  Item group definitions within forms.
• methodDef: array MethodDef
  Method definitions for derivations or calculations.
• name: string
  Human friendly name for this metadata version.

  Example: Base Metadata
• oid: string
  Unique identifier for this metadata version.

  Example: MDV_0001
• presentation: array Presentation
  Presentation configurations for items and forms.
• protocol: object Protocol
  Study protocol definition including description and references to study events.
• studyEventDef: array studyEventDef
  Definitions of study events or visits.

{
    "type":"object",
    "properties":{
        "include":{
            "$ref":"#/components/schemas/Include"
        },
        "protocol":{
            "$ref":"#/components/schemas/Protocol"
        },
        "studyEventDef":{
            "type":"array",
            "description":"Definitions of study events or visits.",
            "items":{
                "$ref":"#/components/schemas/StudyEventDef"
            }
        },
        "formDef":{
            "type":"array",
            "description":"Form definitions contained in events.",
            "items":{
                "$ref":"#/components/schemas/FormDef"
            }
        },
        "itemGroupDef":{
            "type":"array",
            "description":"Item group definitions within forms.",
            "items":{
                "$ref":"#/components/schemas/ItemGroupDef"
            }
        },
        "itemDef":{
            "type":"array",
            "description":"Item definitions used across the study.",
            "items":{
                "$ref":"#/components/schemas/ItemDef"
            }
        },
        "codeList":{
            "type":"array",
            "description":"Code lists used by item definitions.",
            "xml":{
                "name":"CodeList"
            },
            "items":{
                "$ref":"#/components/schemas/CodeList"
            }
        },
        "imputationMethod":{
            "type":"array",
            "description":"Imputation methods available to handle missing data.",
            "xml":{
                "name":"ImputationMethod"
            },
            "items":{
                "$ref":"#/components/schemas/ImputationMethod"
            }
        },
        "presentation":{
            "type":"array",
            "description":"Presentation configurations for items and forms.",
            "xml":{
                "name":"Presentation"
            },
            "items":{
                "$ref":"#/components/schemas/Presentation"
            }
        },
        "conditionDef":{
            "type":"array",
            "description":"Conditional logic definitions used in the study.",
            "xml":{
                "name":"ConditionDef"
            },
            "items":{
                "$ref":"#/components/schemas/ConditionDef"
            }
        },
        "methodDef":{
            "type":"array",
            "description":"Method definitions for derivations or calculations.",
            "xml":{
                "name":"MethodDef"
            },
            "items":{
                "$ref":"#/components/schemas/MethodDef"
            }
        },
        "oid":{
            "type":"string",
            "description":"Unique identifier for this metadata version.",
            "example":"MDV_0001",
            "xml":{
                "name":"OID",
                "attribute":true
            }
        },
        "name":{
            "type":"string",
            "description":"Human friendly name for this metadata version.",
            "example":"Base Metadata",
            "xml":{
                "name":"Name",
                "attribute":true
            }
        },
        "description":{
            "type":"string",
            "description":"Optional description for this metadata version.",
            "example":"Initial metadata version",
            "xml":{
                "name":"Description",
                "attribute":true
            }
        }
    },
    "description":"Defines the study design and data structures including events, forms, items, code lists and methods.",
    "example":"<MetaDataVersionOID=\"STUDY01v1.0.0.3\"Name=\"STUDY01\"co:StudyWid=\"25\"co:GUID=\"0C7CBA3F70034C47947E2FAB086BFBF5\"co:VersionStart=\"2025-10-29T14:37:54.638Z\"><Protocol><StudyEventRefStudyEventOID=\"AE_DBB3A65B0A97454DAFEAEDDAB37395A1\"OrderNumber=\"1\"Mandatory=\"No\"></StudyEventRef><StudyEventRefStudyEventOID=\"SCR_FD227430BECA4DECA5EA8B0E4DBE18CA\"OrderNumber=\"2\"Mandatory=\"Yes\"></StudyEventRef><StudyEventRefStudyEventOID=\"Baseline_5DF278EB00F24820B9CEFE7BFD7A3078\"OrderNumber=\"3\"Mandatory=\"Yes\"></StudyEventRef></Protocol><StudyEventDefOID=\"CBVisit2_AD5ACD1ED5E346129C6FABE4FA2E7DBE\"Name=\"CBVISIT2\"Repeating=\"No\"Type=\"Scheduled\"Category=\"ScheduleAbleVisit\"co:StudyEventWid=\"248\"co:GUID=\"AD5ACD1ED5E346129C6FABE4FA2E7DBE\"co:VersionStart=\"2025-10-29T14:37:55.423Z\"co:DelayDays=\"4\"co:DelayHours=\"0\"co:DelayWindowBeforeDays=\"2\"co:DelayWindowBeforeHours=\"0\"co:DelayWindowAfterDays=\"2\"co:DelayWindowAfterHours=\"0\"><FormRefFormOID=\"VITAL_SIGNS_FORM_TO_COLLECT_MEASUREMENT_3ADB1375C6714B8C97CA14AFA175D739\"OrderNumber=\"1\"Mandatory=\"Yes\"></FormRef><FormRefFormOID=\"TWOSECTIONF1_19E7EE6903814132A9427E3E7A297107\"OrderNumber=\"2\"Mandatory=\"Yes\"></FormRef></StudyEventDef><FormDefOID=\"DECISION_FORM_FOR_BRANCH_026521949ED24C69B0A82084832A3262\"Name=\"DecisionFrom For Branch\"Repeating=\"No\"><ItemGroupRefOrderNumber=\"1\"Mandatory=\"No\"ItemGroupOID=\"IG_DATE_TIME_6ED56EC23ADD4841B8AC22ECB6205774\"></ItemGroupRef><ItemGroupRefOrderNumber=\"2\"Mandatory=\"Yes\"ItemGroupOID=\"IG_ENABLE_DYNAMIC_VISIT_18936986318C4B00AAF89CDA492E6876\"></ItemGroupRef></FormDef><ItemGroupDefOID=\"IG_LAB_FORM_XRAY_E98F15D6F16F425A8F0EC3B92C8B718F\"Name=\"Lab Form - XRAY\"Repeating=\"Yes\"><ItemRefOrderNumber=\"1\"Mandatory=\"No\"ItemOID=\"LB_TEST_0267AEECE55441088516DA2C0E1B2EDC\"></ItemRef><ItemRefOrderNumber=\"2\"Mandatory=\"Yes\"ItemOID=\"LB_RESULT_DE498EE22C884D55A50D285580AB674D\"></ItemRef><ItemRefOrderNumber=\"3\"Mandatory=\"No\"ItemOID=\"LB_UNIT_00C6D2BF3F8B4178AAB25EBD3304E39E\"></ItemRef><ItemRefOrderNumber=\"4\"Mandatory=\"No\"ItemOID=\"LB_LOW_RANGE_C8B8EEFE75F543299542C222ED94C28F\"></ItemRef><ItemRefOrderNumber=\"5\"Mandatory=\"No\"ItemOID=\"LB_HIGH_RANGE_5CE74A4A9E97435B933B6C28645342AA\"></ItemRef><ItemRefOrderNumber=\"6\"Mandatory=\"No\"ItemOID=\"NORMAL_TEXT_RESULT_746B6577A50C4D0A9DB53E1CD6B60551\"></ItemRef></ItemGroupDef><ItemDefOID=\"SUBJECT_INITIALS_CF149710CBE24A6BB9266E52B5F5BA0F\"Name=\"Subject_Initials\"DataType=\"string\"Length=\"3\"co:ItemWid=\"618\"co:GUID=\"CF149710CBE24A6BB9266E52B5F5BA0F\"co:ItemVersionStart=\"2025-10-29T14:37:55.044Z\"co:Precision=\"0\"co:AllowFutureDate=\"No\"><Question><TranslatedText>SubjectInitials</TranslatedText></Question></ItemDef><CodeListOID=\"GENDER_LAB_GENDER_0056B65135E24D8B960E3E9C4B68E280\"Name=\"Gender\"DataType=\"string\"><CodeListItemCodedValue=\"C46\"co:SelectionOID=\"GENDER_LAB_GENDER_0056B65135E24D8B960E3E9C4B68E280_GENDER_LA2\"><Decode><TranslatedText>Female</TranslatedText></Decode></CodeListItem></CodeList></MetaDataVersion>",
    "xml":{
        "name":"MetaDataVersion",
        "namespace":"http://www.cdisc.org/ns/odm/v1.3"
    }
}

Example:

<MetaDataVersionOID="STUDY01v1.0.0.3"Name="STUDY01"co:StudyWid="25"co:GUID="0C7CBA3F70034C47947E2FAB086BFBF5"co:VersionStart="2025-10-29T14:37:54.638Z"><Protocol><StudyEventRefStudyEventOID="AE_DBB3A65B0A97454DAFEAEDDAB37395A1"OrderNumber="1"Mandatory="No"></StudyEventRef><StudyEventRefStudyEventOID="SCR_FD227430BECA4DECA5EA8B0E4DBE18CA"OrderNumber="2"Mandatory="Yes"></StudyEventRef><StudyEventRefStudyEventOID="Baseline_5DF278EB00F24820B9CEFE7BFD7A3078"OrderNumber="3"Mandatory="Yes"></StudyEventRef></Protocol><StudyEventDefOID="CBVisit2_AD5ACD1ED5E346129C6FABE4FA2E7DBE"Name="CBVISIT2"Repeating="No"Type="Scheduled"Category="ScheduleAbleVisit"co:StudyEventWid="248"co:GUID="AD5ACD1ED5E346129C6FABE4FA2E7DBE"co:VersionStart="2025-10-29T14:37:55.423Z"co:DelayDays="4"co:DelayHours="0"co:DelayWindowBeforeDays="2"co:DelayWindowBeforeHours="0"co:DelayWindowAfterDays="2"co:DelayWindowAfterHours="0"><FormRefFormOID="VITAL_SIGNS_FORM_TO_COLLECT_MEASUREMENT_3ADB1375C6714B8C97CA14AFA175D739"OrderNumber="1"Mandatory="Yes"></FormRef><FormRefFormOID="TWOSECTIONF1_19E7EE6903814132A9427E3E7A297107"OrderNumber="2"Mandatory="Yes"></FormRef></StudyEventDef><FormDefOID="DECISION_FORM_FOR_BRANCH_026521949ED24C69B0A82084832A3262"Name="DecisionFrom For Branch"Repeating="No"><ItemGroupRefOrderNumber="1"Mandatory="No"ItemGroupOID="IG_DATE_TIME_6ED56EC23ADD4841B8AC22ECB6205774"></ItemGroupRef><ItemGroupRefOrderNumber="2"Mandatory="Yes"ItemGroupOID="IG_ENABLE_DYNAMIC_VISIT_18936986318C4B00AAF89CDA492E6876"></ItemGroupRef></FormDef><ItemGroupDefOID="IG_LAB_FORM_XRAY_E98F15D6F16F425A8F0EC3B92C8B718F"Name="Lab Form - XRAY"Repeating="Yes"><ItemRefOrderNumber="1"Mandatory="No"ItemOID="LB_TEST_0267AEECE55441088516DA2C0E1B2EDC"></ItemRef><ItemRefOrderNumber="2"Mandatory="Yes"ItemOID="LB_RESULT_DE498EE22C884D55A50D285580AB674D"></ItemRef><ItemRefOrderNumber="3"Mandatory="No"ItemOID="LB_UNIT_00C6D2BF3F8B4178AAB25EBD3304E39E"></ItemRef><ItemRefOrderNumber="4"Mandatory="No"ItemOID="LB_LOW_RANGE_C8B8EEFE75F543299542C222ED94C28F"></ItemRef><ItemRefOrderNumber="5"Mandatory="No"ItemOID="LB_HIGH_RANGE_5CE74A4A9E97435B933B6C28645342AA"></ItemRef><ItemRefOrderNumber="6"Mandatory="No"ItemOID="NORMAL_TEXT_RESULT_746B6577A50C4D0A9DB53E1CD6B60551"></ItemRef></ItemGroupDef><ItemDefOID="SUBJECT_INITIALS_CF149710CBE24A6BB9266E52B5F5BA0F"Name="Subject_Initials"DataType="string"Length="3"co:ItemWid="618"co:GUID="CF149710CBE24A6BB9266E52B5F5BA0F"co:ItemVersionStart="2025-10-29T14:37:55.044Z"co:Precision="0"co:AllowFutureDate="No"><Question><TranslatedText>SubjectInitials</TranslatedText></Question></ItemDef><CodeListOID="GENDER_LAB_GENDER_0056B65135E24D8B960E3E9C4B68E280"Name="Gender"DataType="string"><CodeListItemCodedValue="C46"co:SelectionOID="GENDER_LAB_GENDER_0056B65135E24D8B960E3E9C4B68E280_GENDER_LA2"><Decode><TranslatedText>Female</TranslatedText></Decode></CodeListItem></CodeList></MetaDataVersion>

Nested Schema : CodeList

Type: array

Code lists used by item definitions.

Show Source

• Array of: object CodeList
  CodeList defining permissible values via CodeListItem/EnumeratedItem or referencing an external catalog.

{
    "type":"array",
    "description":"Code lists used by item definitions.",
    "xml":{
        "name":"CodeList"
    },
    "items":{
        "$ref":"#/components/schemas/CodeList"
    }
}

Nested Schema : ConditionDef

Type: array

Conditional logic definitions used in the study.

Show Source

• Array of: object ConditionDef
  Definition of a condition used within ODM to control logic, exceptions, or method execution.

{
    "type":"array",
    "description":"Conditional logic definitions used in the study.",
    "xml":{
        "name":"ConditionDef"
    },
    "items":{
        "$ref":"#/components/schemas/ConditionDef"
    }
}

Nested Schema : formDef

Type: array

Form definitions contained in events.

Show Source

• Array of: object FormDef
  Form definition containing item group references, archive layout, and metadata.

{
    "type":"array",
    "description":"Form definitions contained in events.",
    "items":{
        "$ref":"#/components/schemas/FormDef"
    }
}

Nested Schema : ImputationMethod

Type: array

Imputation methods available to handle missing data.

Show Source

• Array of: object ImputationMethod
  ImputationMethod element describing how missing values are imputed.

{
    "type":"array",
    "description":"Imputation methods available to handle missing data.",
    "xml":{
        "name":"ImputationMethod"
    },
    "items":{
        "$ref":"#/components/schemas/ImputationMethod"
    }
}

Nested Schema : Include

Type: object

Reference to another study and metadata version within ODM.

Show Source

• metaDataVersionOID: string
  Referenced metadata version OID.

  Example: MDV_0001
• studyOID: string
  Referenced study OID.

  Example: S_0001

{
    "type":"object",
    "properties":{
        "studyOID":{
            "type":"string",
            "description":"Referenced study OID.",
            "example":"S_0001",
            "xml":{
                "name":"StudyOID",
                "attribute":true
            }
        },
        "metaDataVersionOID":{
            "type":"string",
            "description":"Referenced metadata version OID.",
            "example":"MDV_0001",
            "xml":{
                "name":"MetaDataVersionOID",
                "attribute":true
            }
        }
    },
    "description":"Reference to another study and metadata version within ODM.",
    "example":{
        "studyOID":"S_0001",
        "metaDataVersionOID":"MDV_0001"
    }
}

Example:

{
    "studyOID":"S_0001",
    "metaDataVersionOID":"MDV_0001"
}

Nested Schema : itemDef

Type: array

Item definitions used across the study.

Show Source

• Array of: object ItemDef
  Item definition including data type, question text, range checks, code list reference, and metadata.

{
    "type":"array",
    "description":"Item definitions used across the study.",
    "items":{
        "$ref":"#/components/schemas/ItemDef"
    }
}

Nested Schema : itemGroupDef

Type: array

Item group definitions within forms.

Show Source

• Array of: object ItemGroupDef
  Item group definition aggregating item references, attributes, and metadata.

{
    "type":"array",
    "description":"Item group definitions within forms.",
    "items":{
        "$ref":"#/components/schemas/ItemGroupDef"
    }
}

Nested Schema : MethodDef

Type: array

Method definitions for derivations or calculations.

Show Source

• Array of: object MethodDef
  Definition of a computation or derivation used within the ODM metadata, including description, formal expressions, aliases, and attributes.

{
    "type":"array",
    "description":"Method definitions for derivations or calculations.",
    "xml":{
        "name":"MethodDef"
    },
    "items":{
        "$ref":"#/components/schemas/MethodDef"
    }
}

Nested Schema : Presentation

Type: array

Presentation configurations for items and forms.

Show Source

• Array of: object Presentation
  Presentation element containing display text and metadata.

{
    "type":"array",
    "description":"Presentation configurations for items and forms.",
    "xml":{
        "name":"Presentation"
    },
    "items":{
        "$ref":"#/components/schemas/Presentation"
    }
}

Nested Schema : Protocol

Type: object

Study protocol definition including description and references to study events.

Show Source

• alias: array Alias
  Optional aliases for the protocol.
• description: object Description
  Localized description containing one or more translated text entries.
• studyEventRef: array StudyEventRef
  References to study events that constitute the schedule of assessments.

{
    "type":"object",
    "properties":{
        "description":{
            "$ref":"#/components/schemas/Description"
        },
        "studyEventRef":{
            "type":"array",
            "description":"References to study events that constitute the schedule of assessments.",
            "xml":{
                "name":"StudyEventRef"
            },
            "items":{
                "$ref":"#/components/schemas/StudyEventRef"
            }
        },
        "alias":{
            "type":"array",
            "description":"Optional aliases for the protocol.",
            "xml":{
                "name":"Alias"
            },
            "items":{
                "$ref":"#/components/schemas/Alias"
            }
        }
    },
    "description":"Study protocol definition including description and references to study events.",
    "example":{
        "description":{
            "translatedText":[
                {
                    "value":"Protocol overview",
                    "lang":"en"
                }
            ]
        },
        "studyEventRef":[
            {
                "studyEventOID":"SE_VISIT1",
                "orderNumber":1,
                "mandatory":"Yes",
                "collectionExceptionConditionOID":"COND_001"
            }
        ],
        "alias":[
            {
                "context":"SPONSOR",
                "name":"PROTO-001"
            }
        ]
    }
}

Example:

{
    "description":{
        "translatedText":[
            {
                "value":"Protocol overview",
                "lang":"en"
            }
        ]
    },
    "studyEventRef":[
        {
            "studyEventOID":"SE_VISIT1",
            "orderNumber":1,
            "mandatory":"Yes",
            "collectionExceptionConditionOID":"COND_001"
        }
    ],
    "alias":[
        {
            "context":"SPONSOR",
            "name":"PROTO-001"
        }
    ]
}

Nested Schema : studyEventDef

Type: array

Definitions of study events or visits.

Show Source

• Array of: object StudyEventDef
  Study event definition containing form references, scheduling attributes, and metadata.

{
    "type":"array",
    "description":"Definitions of study events or visits.",
    "items":{
        "$ref":"#/components/schemas/StudyEventDef"
    }
}

Nested Schema : CodeList

Type: object

CodeList defining permissible values via CodeListItem/EnumeratedItem or referencing an external catalog.

Show Source

• alias: array Alias
  Aliases that provide cross-references (e.g., SDTM variable names).
• codeListItem: array codeListItem
  Permissible values as coded items. Use when values are explicitly enumerated.
• dataType: string
  Allowed Values: [ "INTEGER", "FLOAT", "TEXT", "STRING" ]

  Data type for values in this CodeList.

  Example: text
• description: object Description
  Localized description containing one or more translated text entries.
• enumeratedItem: array EnumeratedItem
  Alternate representation of permissible values as enumerated items.
• externalCodeList: object ExternalCodeList
  Reference to an external catalog-based code list.
• name: string
  Display name of the CodeList.

  Example: AgeUnits
• oid: string
  Object identifier for this CodeList.

  Example: CL.AGE
• sasformatName: string

{
    "type":"object",
    "properties":{
        "description":{
            "$ref":"#/components/schemas/Description"
        },
        "codeListItem":{
            "type":"array",
            "description":"Permissible values as coded items. Use when values are explicitly enumerated.",
            "items":{
                "$ref":"#/components/schemas/CodeListItem"
            }
        },
        "externalCodeList":{
            "$ref":"#/components/schemas/ExternalCodeList"
        },
        "enumeratedItem":{
            "type":"array",
            "description":"Alternate representation of permissible values as enumerated items.",
            "xml":{
                "name":"EnumeratedItem"
            },
            "items":{
                "$ref":"#/components/schemas/EnumeratedItem"
            }
        },
        "alias":{
            "type":"array",
            "description":"Aliases that provide cross-references (e.g., SDTM variable names).",
            "xml":{
                "name":"Alias"
            },
            "items":{
                "$ref":"#/components/schemas/Alias"
            }
        },
        "oid":{
            "type":"string",
            "description":"Object identifier for this CodeList.",
            "example":"CL.AGE",
            "xml":{
                "name":"OID",
                "attribute":true
            }
        },
        "name":{
            "type":"string",
            "description":"Display name of the CodeList.",
            "example":"AgeUnits",
            "xml":{
                "name":"Name",
                "attribute":true
            }
        },
        "dataType":{
            "type":"string",
            "description":"Data type for values in this CodeList.",
            "example":"text",
            "xml":{
                "name":"DataType",
                "attribute":true
            },
            "enum":[
                "INTEGER",
                "FLOAT",
                "TEXT",
                "STRING"
            ]
        },
        "sasformatName":{
            "type":"string"
        }
    },
    "description":"CodeList defining permissible values via CodeListItem/EnumeratedItem or referencing an external catalog.",
    "example":"<CodeList OID=\"CL.AGE\" Name=\"AgeUnits\" DataType=\"text\" SASFormatName=\"AGEFMT\"><Description>Age units used for subject age</Description><CodeListItem CodedValue=\"YEARS\"><Decode><TranslatedText xml:lang=\"en\">Years</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue=\"MONTHS\"><Decode><TranslatedText xml:lang=\"en\">Months</TranslatedText></Decode></CodeListItem><Alias Context=\"SDTM\" Name=\"AGEU\"/></CodeList>"
}

Example:

<CodeList OID="CL.AGE" Name="AgeUnits" DataType="text" SASFormatName="AGEFMT"><Description>Age units used for subject age</Description><CodeListItem CodedValue="YEARS"><Decode><TranslatedText xml:lang="en">Years</TranslatedText></Decode></CodeListItem><CodeListItem CodedValue="MONTHS"><Decode><TranslatedText xml:lang="en">Months</TranslatedText></Decode></CodeListItem><Alias Context="SDTM" Name="AGEU"/></CodeList>

Nested Schema : Alias

Type: array

Aliases that provide cross-references (e.g., SDTM variable names).

Show Source

• Array of: object Alias
  Alternative naming context and value for an ODM element.

{
    "type":"array",
    "description":"Aliases that provide cross-references (e.g., SDTM variable names).",
    "xml":{
        "name":"Alias"
    },
    "items":{
        "$ref":"#/components/schemas/Alias"
    }
}

Nested Schema : codeListItem

Type: array

Permissible values as coded items. Use when values are explicitly enumerated.

Show Source

• Array of: object CodeListItem
  Permissible values as coded items. Use when values are explicitly enumerated.

{
    "type":"array",
    "description":"Permissible values as coded items. Use when values are explicitly enumerated.",
    "items":{
        "$ref":"#/components/schemas/CodeListItem"
    }
}

Nested Schema : Description

Type: object

Localized description containing one or more translated text entries.

Show Source

• translatedText(required): array TranslatedText
  Localized description text entries.

{
    "required":[
        "translatedText"
    ],
    "type":"object",
    "properties":{
        "translatedText":{
            "type":"array",
            "description":"Localized description text entries.",
            "xml":{
                "name":"TranslatedText"
            },
            "items":{
                "$ref":"#/components/schemas/TranslatedText"
            }
        }
    },
    "description":"Localized description containing one or more translated text entries.",
    "example":"<Description>\n  <TranslatedText xml:lang=\"en\">Protocol overview</TranslatedText>\n</Description>"
}

Example:

<Description>
  <TranslatedText xml:lang="en">Protocol overview</TranslatedText>
</Description>

Nested Schema : EnumeratedItem

Type: array

Alternate representation of permissible values as enumerated items.

Show Source

• Array of: object EnumeratedItem
  Alternate representation of permissible values as enumerated items.

{
    "type":"array",
    "description":"Alternate representation of permissible values as enumerated items.",
    "xml":{
        "name":"EnumeratedItem"
    },
    "items":{
        "$ref":"#/components/schemas/EnumeratedItem"
    }
}

Nested Schema : ExternalCodeList

Type: object

Reference to an external catalog-based code list.

Show Source

• dictionary: string
• href: string
• ref: string
• version: string

{
    "type":"object",
    "properties":{
        "href":{
            "type":"string",
            "xml":{
                "attribute":true
            }
        },
        "ref":{
            "type":"string",
            "xml":{
                "attribute":true
            }
        },
        "dictionary":{
            "type":"string",
            "xml":{
                "name":"Dictionary",
                "attribute":true
            }
        },
        "version":{
            "type":"string",
            "xml":{
                "name":"Version",
                "attribute":true
            }
        }
    },
    "description":"Reference to an external catalog-based code list."
}

Nested Schema : CodeListItem

Type: object

Permissible values as coded items. Use when values are explicitly enumerated.

Show Source

• alias: array Alias
• codedValue: string
• decode(required): object Decode
• orderNumber: integer
• rank: number

{
    "required":[
        "decode"
    ],
    "type":"object",
    "properties":{
        "decode":{
            "$ref":"#/components/schemas/Decode"
        },
        "alias":{
            "type":"array",
            "xml":{
                "name":"Alias"
            },
            "items":{
                "$ref":"#/components/schemas/Alias"
            }
        },
        "codedValue":{
            "type":"string",
            "xml":{
                "name":"CodedValue",
                "attribute":true
            }
        },
        "rank":{
            "type":"number",
            "xml":{
                "name":"Rank",
                "attribute":true
            }
        },
        "orderNumber":{
            "type":"integer",
            "xml":{
                "name":"OrderNumber",
                "attribute":true
            }
        }
    },
    "description":"Permissible values as coded items. Use when values are explicitly enumerated.",
    "xml":{
        "name":"CodeListItem",
        "namespace":"http://www.cdisc.org/ns/odm/v1.3"
    }
}

Nested Schema : Alias

Type: array

Show Source

• Array of: object Alias
  Alternative naming context and value for an ODM element.

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

Nested Schema : Decode

Type: object

Show Source

• translatedText(required): array TranslatedText

{
    "required":[
        "translatedText"
    ],
    "type":"object",
    "properties":{
        "translatedText":{
            "type":"array",
            "xml":{
                "name":"TranslatedText"
            },
            "items":{
                "$ref":"#/components/schemas/TranslatedText"
            }
        }
    }
}

Nested Schema : TranslatedText

Type: array

Show Source

• Array of: object TranslatedText
  Localized text value with associated language code.

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

Nested Schema : TranslatedText

Type: array

Localized description text entries.

Show Source

• Array of: object TranslatedText
  Localized text value with associated language code.

{
    "type":"array",
    "description":"Localized description text entries.",
    "xml":{
        "name":"TranslatedText"
    },
    "items":{
        "$ref":"#/components/schemas/TranslatedText"
    }
}

Nested Schema : EnumeratedItem

Type: object

Alternate representation of permissible values as enumerated items.

Show Source

• alias: array Alias
• codedValue: string
• orderNumber: integer
• rank: number

{
    "type":"object",
    "properties":{
        "alias":{
            "type":"array",
            "xml":{
                "name":"Alias"
            },
            "items":{
                "$ref":"#/components/schemas/Alias"
            }
        },
        "codedValue":{
            "type":"string",
            "xml":{
                "name":"CodedValue",
                "attribute":true
            }
        },
        "rank":{
            "type":"number",
            "xml":{
                "name":"Rank",
                "attribute":true
            }
        },
        "orderNumber":{
            "type":"integer",
            "xml":{
                "name":"OrderNumber",
                "attribute":true
            }
        }
    },
    "description":"Alternate representation of permissible values as enumerated items."
}

Nested Schema : Alias

Type: array

Show Source

• Array of: object Alias
  Alternative naming context and value for an ODM element.

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

Nested Schema : ConditionDef

Type: object

Definition of a condition used within ODM to control logic, exceptions, or method execution.

Show Source

• alias: array Alias
  Optional aliases for the condition.
• description(required): object Description
  Localized description containing one or more translated text entries.
• formalExpression: array FormalExpression
  One or more formal expressions defining the condition logic.
• name: string
  Display name for the condition.

  Example: Weight Check
• oid: string
  Unique identifier for the condition within the ODM context.

  Example: COND.WEIGHT_CHECK

{
    "required":[
        "description"
    ],
    "type":"object",
    "properties":{
        "description":{
            "$ref":"#/components/schemas/Description"
        },
        "formalExpression":{
            "type":"array",
            "description":"One or more formal expressions defining the condition logic.",
            "xml":{
                "name":"FormalExpression"
            },
            "items":{
                "$ref":"#/components/schemas/FormalExpression"
            }
        },
        "alias":{
            "type":"array",
            "description":"Optional aliases for the condition.",
            "xml":{
                "name":"Alias"
            },
            "items":{
                "$ref":"#/components/schemas/Alias"
            }
        },
        "oid":{
            "type":"string",
            "description":"Unique identifier for the condition within the ODM context.",
            "example":"COND.WEIGHT_CHECK",
            "xml":{
                "name":"OID",
                "attribute":true
            }
        },
        "name":{
            "type":"string",
            "description":"Display name for the condition.",
            "example":"Weight Check",
            "xml":{
                "name":"Name",
                "attribute":true
            }
        }
    },
    "description":"Definition of a condition used within ODM to control logic, exceptions, or method execution.",
    "example":"<ConditionDef OID=\"COND.WEIGHT_CHECK\" Name=\"Weight Check\">\n  <Description>\n    <TranslatedText xml:lang=\"en\">Check weight-based dosing</TranslatedText>\n  </Description>\n  <FormalExpression Context=\"SAS\">if (WEIGHT GT 0) then DOSE=WEIGHT*CONC; else DOSE=.;</FormalExpression>\n  <Alias Context=\"bookmark\" Name=\"WeightCheck\"/>\n</ConditionDef>"
}

Example:

<ConditionDef OID="COND.WEIGHT_CHECK" Name="Weight Check">
  <Description>
    <TranslatedText xml:lang="en">Check weight-based dosing</TranslatedText>
  </Description>
  <FormalExpression Context="SAS">if (WEIGHT GT 0) then DOSE=WEIGHT*CONC; else DOSE=.;</FormalExpression>
  <Alias Context="bookmark" Name="WeightCheck"/>
</ConditionDef>

Nested Schema : Alias

Type: array

Optional aliases for the condition.

Show Source

• Array of: object Alias
  Alternative naming context and value for an ODM element.

{
    "type":"array",
    "description":"Optional aliases for the condition.",
    "xml":{
        "name":"Alias"
    },
    "items":{
        "$ref":"#/components/schemas/Alias"
    }
}

Nested Schema : FormalExpression

Type: array

One or more formal expressions defining the condition logic.

Show Source

• Array of: object FormalExpression
  Expression representing method logic in a specific execution context or language.

{
    "type":"array",
    "description":"One or more formal expressions defining the condition logic.",
    "xml":{
        "name":"FormalExpression"
    },
    "items":{
        "$ref":"#/components/schemas/FormalExpression"
    }
}

Nested Schema : FormalExpression

Type: object

Expression representing method logic in a specific execution context or language.

Show Source

• context: string
  Execution context or language for the expression.

  Example: SAS
• value: string
  Formal expression text.

  Example: if (WEIGHT GT 0) then DOSE=WEIGHT*CONC; else DOSE=.;

{
    "type":"object",
    "properties":{
        "value":{
            "type":"string",
            "description":"Formal expression text.",
            "example":"if (WEIGHT GT 0) then DOSE=WEIGHT*CONC; else DOSE=.;"
        },
        "context":{
            "type":"string",
            "description":"Execution context or language for the expression.",
            "example":"SAS",
            "xml":{
                "name":"Context",
                "attribute":true
            }
        }
    },
    "description":"Expression representing method logic in a specific execution context or language.",
    "example":"<FormalExpression Context=\"SAS\">if (WEIGHT GT 0) then DOSE=WEIGHT*CONC; else DOSE=.;</FormalExpression>"
}

Example:

<FormalExpression Context="SAS">if (WEIGHT GT 0) then DOSE=WEIGHT*CONC; else DOSE=.;</FormalExpression>

Nested Schema : FormDef

Type: object

Form definition containing item group references, archive layout, and metadata.

Show Source

• alias: array Alias
  Aliases providing cross-references, e.g., SDTM mapping.
• archiveLayout: array ArchiveLayout
  Archive layout definitions for this form.
• description: object Description
  Localized description containing one or more translated text entries.
• itemGroupRef: array ItemGroupRef
  References to item groups included in this form.
• name: string
  Display name of the form.

  Example: Demographics Form
• oid: string
  Object identifier for the FormDef.

  Example: FRM.DEMO
• repeating: string
  Allowed Values: [ "YES", "NO", "Yes", "No" ]

  Represents a Yes or No value.

  Example: Yes

{
    "type":"object",
    "properties":{
        "description":{
            "$ref":"#/components/schemas/Description"
        },
        "itemGroupRef":{
            "type":"array",
            "description":"References to item groups included in this form.",
            "xml":{
                "name":"ItemGroupRef"
            },
            "items":{
                "$ref":"#/components/schemas/ItemGroupRef"
            }
        },
        "archiveLayout":{
            "type":"array",
            "description":"Archive layout definitions for this form.",
            "xml":{
                "name":"ArchiveLayout"
            },
            "items":{
                "$ref":"#/components/schemas/ArchiveLayout"
            }
        },
        "alias":{
            "type":"array",
            "description":"Aliases providing cross-references, e.g., SDTM mapping.",
            "xml":{
                "name":"Alias"
            },
            "items":{
                "$ref":"#/components/schemas/Alias"
            }
        },
        "oid":{
            "type":"string",
            "description":"Object identifier for the FormDef.",
            "example":"FRM.DEMO",
            "xml":{
                "name":"OID",
                "attribute":true
            }
        },
        "name":{
            "type":"string",
            "description":"Display name of the form.",
            "example":"Demographics Form",
            "xml":{
                "name":"Name",
                "attribute":true
            }
        },
        "repeating":{
            "type":"string",
            "description":"Represents a Yes or No value.",
            "example":"Yes",
            "xml":{
                "name":"Repeating",
                "attribute":true
            },
            "enum":[
                "YES",
                "NO",
                "Yes",
                "No"
            ]
        }
    },
    "description":"Form definition containing item group references, archive layout, and metadata.",
    "example":"<FormDef OID=\"FRM.DEMO\" Name=\"Demographics Form\" Repeating=\"No\"><Description>Form capturing demographic information</Description><ItemGroupRef ItemGroupOID=\"IG.DEMO\" Mandatory=\"Yes\" OrderNumber=\"1\"/><ArchiveLayout Name=\"DefaultLayout\"/><Alias Context=\"SDTM\" Name=\"DM\"/></FormDef>",
    "xml":{
        "name":"FormDef",
        "namespace":"http://www.cdisc.org/ns/odm/v1.3"
    }
}

Example:

<FormDef OID="FRM.DEMO" Name="Demographics Form" Repeating="No"><Description>Form capturing demographic information</Description><ItemGroupRef ItemGroupOID="IG.DEMO" Mandatory="Yes" OrderNumber="1"/><ArchiveLayout Name="DefaultLayout"/><Alias Context="SDTM" Name="DM"/></FormDef>

Nested Schema : Alias

Type: array

Aliases providing cross-references, e.g., SDTM mapping.

Show Source

• Array of: object Alias
  Alternative naming context and value for an ODM element.

{
    "type":"array",
    "description":"Aliases providing cross-references, e.g., SDTM mapping.",
    "xml":{
        "name":"Alias"
    },
    "items":{
        "$ref":"#/components/schemas/Alias"
    }
}

Nested Schema : ArchiveLayout

Type: array

Archive layout definitions for this form.

Show Source

• Array of: object ArchiveLayout
  Archive layout definitions for this form.

{
    "type":"array",
    "description":"Archive layout definitions for this form.",
    "xml":{
        "name":"ArchiveLayout"
    },
    "items":{
        "$ref":"#/components/schemas/ArchiveLayout"
    }
}

Nested Schema : ItemGroupRef

Type: array

References to item groups included in this form.

Show Source

• Array of: object ItemGroupRef
  References to item groups included in this form.

{
    "type":"array",
    "description":"References to item groups included in this form.",
    "xml":{
        "name":"ItemGroupRef"
    },
    "items":{
        "$ref":"#/components/schemas/ItemGroupRef"
    }
}

Nested Schema : ArchiveLayout

Type: object

Archive layout definitions for this form.

Show Source

• oid: string
• pdfFileName: string
• presentationOID: string

{
    "type":"object",
    "properties":{
        "oid":{
            "type":"string",
            "xml":{
                "name":"OID",
                "attribute":true
            }
        },
        "pdfFileName":{
            "type":"string",
            "xml":{
                "name":"PdfFileName",
                "attribute":true
            }
        },
        "presentationOID":{
            "type":"string",
            "xml":{
                "name":"PresentationOID",
                "attribute":true
            }
        }
    },
    "description":"Archive layout definitions for this form."
}

Nested Schema : ItemGroupRef

Type: object

References to item groups included in this form.

Show Source

• collectionExceptionConditionOID: string
• itemGroupOID: string
• mandatory: string
  Allowed Values: [ "YES", "NO", "Yes", "No" ]

  Represents a Yes or No value.

  Example: Yes
• orderNumber: integer

{
    "type":"object",
    "properties":{
        "orderNumber":{
            "type":"integer",
            "xml":{
                "name":"OrderNumber",
                "attribute":true
            }
        },
        "mandatory":{
            "type":"string",
            "description":"Represents a Yes or No value.",
            "example":"Yes",
            "xml":{
                "name":"Mandatory",
                "attribute":true
            },
            "enum":[
                "YES",
                "NO",
                "Yes",
                "No"
            ]
        },
        "collectionExceptionConditionOID":{
            "type":"string",
            "xml":{
                "name":"CollectionExceptionConditionOID",
                "attribute":true
            }
        },
        "itemGroupOID":{
            "type":"string",
            "xml":{
                "name":"ItemGroupOID",
                "attribute":true
            }
        }
    },
    "description":"References to item groups included in this form."
}

Nested Schema : ImputationMethod

Type: object

ImputationMethod element describing how missing values are imputed.

Show Source

• oid: string
  Object identifier for the ImputationMethod element.

  Example: IMP001
• value: string
  Imputation method text content.

  Example: Mean Imputation

{
    "type":"object",
    "properties":{
        "value":{
            "type":"string",
            "description":"Imputation method text content.",
            "example":"Mean Imputation"
        },
        "oid":{
            "type":"string",
            "description":"Object identifier for the ImputationMethod element.",
            "example":"IMP001",
            "xml":{
                "name":"OID",
                "attribute":true
            }
        }
    },
    "description":"ImputationMethod element describing how missing values are imputed.",
    "example":"<ImputationMethod OID=\"IMP001\">Mean Imputation</ImputationMethod>"
}

Example:

<ImputationMethod OID="IMP001">Mean Imputation</ImputationMethod>

Nested Schema : ItemDef

Type: object

Item definition including data type, question text, range checks, code list reference, and metadata.

Show Source

• alias: array Alias
  Aliases providing cross-references, e.g., to SDTM.
• codeListRef: object CodeListRef
  Reference to a CodeList that constrains values for this item.
• comment: string
  Optional comment regarding the item.

  Example: Age of subject
• dataType: string
  Allowed Values: [ "INTEGER", "FLOAT", "DATE", "DATETIME", "TIME", "TEXT", "STRING", "DOUBLE", "URI", "BOOLEAN", "HEX_BINARY", "BASE_64_BINARY", "HEX_FLOAT", "BASE_64_FLOAT", "PARTIAL_DATE", "PARTIAL_TIME", "PARTIAL_DATETIME", "DURATION_DATETIME", "INTERVAL_DATETIME", "INCOMPLETE_DATETIME", "INCOMPLETE_DATE", "INCOMPLETE_TIME" ]

  Data type of the item value.

  Example: integer
• description: object Description
  Localized description containing one or more translated text entries.
• externalQuestion: object ExternalQuestion
  Optional external question metadata reference.
• length: integer
  Maximum length for character or numeric fields.

  Example: 3
• measurementUnitRef: array MeasurementUnitRef
  List of measurement units referenced by this item.
• name: string
  Display name of the item.

  Example: Age
• oid: string
  Object identifier for the ItemDef.

  Example: IT.AGE
• origin: string
  Origin of the item value (e.g., Collected, Derived).

  Example: Collected
• question: object Question
  Primary question text associated with the ItemDef.
• rangeCheck: array RangeCheck
  Validation constraints for values of this item.
• role: array Role
  Roles associated with this item.
• sasfieldName: string
• sdsvarName: string
• significantDigits: integer
  Number of significant digits for numeric values.

  Example: 0

{
    "type":"object",
    "properties":{
        "description":{
            "$ref":"#/components/schemas/Description"
        },
        "question":{
            "$ref":"#/components/schemas/Question"
        },
        "externalQuestion":{
            "$ref":"#/components/schemas/ExternalQuestion"
        },
        "measurementUnitRef":{
            "type":"array",
            "description":"List of measurement units referenced by this item.",
            "xml":{
                "name":"MeasurementUnitRef"
            },
            "items":{
                "$ref":"#/components/schemas/MeasurementUnitRef"
            }
        },
        "rangeCheck":{
            "type":"array",
            "description":"Validation constraints for values of this item.",
            "xml":{
                "name":"RangeCheck"
            },
            "items":{
                "$ref":"#/components/schemas/RangeCheck"
            }
        },
        "codeListRef":{
            "$ref":"#/components/schemas/CodeListRef"
        },
        "role":{
            "type":"array",
            "description":"Roles associated with this item.",
            "xml":{
                "name":"Role"
            },
            "items":{
                "$ref":"#/components/schemas/Role"
            }
        },
        "alias":{
            "type":"array",
            "description":"Aliases providing cross-references, e.g., to SDTM.",
            "xml":{
                "name":"Alias"
            },
            "items":{
                "$ref":"#/components/schemas/Alias"
            }
        },
        "oid":{
            "type":"string",
            "description":"Object identifier for the ItemDef.",
            "example":"IT.AGE",
            "xml":{
                "name":"OID",
                "attribute":true
            }
        },
        "name":{
            "type":"string",
            "description":"Display name of the item.",
            "example":"Age",
            "xml":{
                "name":"Name",
                "attribute":true
            }
        },
        "dataType":{
            "type":"string",
            "description":"Data type of the item value.",
            "example":"integer",
            "xml":{
                "name":"DataType",
                "attribute":true
            },
            "enum":[
                "INTEGER",
                "FLOAT",
                "DATE",
                "DATETIME",
                "TIME",
                "TEXT",
                "STRING",
                "DOUBLE",
                "URI",
                "BOOLEAN",
                "HEX_BINARY",
                "BASE_64_BINARY",
                "HEX_FLOAT",
                "BASE_64_FLOAT",
                "PARTIAL_DATE",
                "PARTIAL_TIME",
                "PARTIAL_DATETIME",
                "DURATION_DATETIME",
                "INTERVAL_DATETIME",
                "INCOMPLETE_DATETIME",
                "INCOMPLETE_DATE",
                "INCOMPLETE_TIME"
            ]
        },
        "length":{
            "type":"integer",
            "description":"Maximum length for character or numeric fields.",
            "example":3,
            "xml":{
                "name":"Length",
                "attribute":true
            }
        },
        "significantDigits":{
            "type":"integer",
            "description":"Number of significant digits for numeric values.",
            "example":0,
            "xml":{
                "name":"SignificantDigits",
                "attribute":true
            }
        },
        "origin":{
            "type":"string",
            "description":"Origin of the item value (e.g., Collected, Derived).",
            "example":"Collected",
            "xml":{
                "name":"Origin",
                "attribute":true
            }
        },
        "comment":{
            "type":"string",
            "description":"Optional comment regarding the item.",
            "example":"Age of subject",
            "xml":{
                "name":"Comment",
                "attribute":true
            }
        },
        "sdsvarName":{
            "type":"string"
        },
        "sasfieldName":{
            "type":"string"
        }
    },
    "description":"Item definition including data type, question text, range checks, code list reference, and metadata.",
    "example":"<ItemDef OID=\"IT.AGE\" Name=\"Age\" DataType=\"integer\" Length=\"3\" SignificantDigits=\"0\" SASFieldName=\"AGE\" SDSVarName=\"AGE\" Origin=\"Collected\" Comment=\"Age of subject\"><Description>Subject age in years</Description><Question>What is the subject's age?</Question><MeasurementUnitRef MeasurementUnitOID=\"MU.YEARS\"/><RangeCheck Comparator=\"GE\" SoftHard=\"Soft\"><CheckValue>0</CheckValue></RangeCheck><RangeCheck Comparator=\"LE\" SoftHard=\"Soft\"><CheckValue>130</CheckValue></RangeCheck><CodeListRef CodeListOID=\"CL.AGEU\"/><Role>Demographics</Role><Alias Context=\"SDTM\" Name=\"AGE\"/></ItemDef>",
    "xml":{
        "name":"ItemDef",
        "namespace":"http://www.cdisc.org/ns/odm/v1.3"
    }
}

Example:

<ItemDef OID="IT.AGE" Name="Age" DataType="integer" Length="3" SignificantDigits="0" SASFieldName="AGE" SDSVarName="AGE" Origin="Collected" Comment="Age of subject"><Description>Subject age in years</Description><Question>What is the subject's age?</Question><MeasurementUnitRef MeasurementUnitOID="MU.YEARS"/><RangeCheck Comparator="GE" SoftHard="Soft"><CheckValue>0</CheckValue></RangeCheck><RangeCheck Comparator="LE" SoftHard="Soft"><CheckValue>130</CheckValue></RangeCheck><CodeListRef CodeListOID="CL.AGEU"/><Role>Demographics</Role><Alias Context="SDTM" Name="AGE"/></ItemDef>

Nested Schema : Alias

Type: array

Aliases providing cross-references, e.g., to SDTM.

Show Source

• Array of: object Alias
  Alternative naming context and value for an ODM element.

{
    "type":"array",
    "description":"Aliases providing cross-references, e.g., to SDTM.",
    "xml":{
        "name":"Alias"
    },
    "items":{
        "$ref":"#/components/schemas/Alias"
    }
}

Nested Schema : CodeListRef

Type: object

Reference to a CodeList that constrains values for this item.

Show Source

• codeListOID: string

{
    "type":"object",
    "properties":{
        "codeListOID":{
            "type":"string",
            "xml":{
                "name":"CodeListOID",
                "attribute":true
            }
        }
    },
    "description":"Reference to a CodeList that constrains values for this item."
}

Nested Schema : ExternalQuestion

Type: object

Optional external question metadata reference.

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• code: string
• dictionary: string
• version: string

{
    "type":"object",
    "properties":{
        "dictionary":{
            "type":"string",
            "xml":{
                "name":"Dictionary",
                "attribute":true
            }
        },
        "version":{
            "type":"string",
            "xml":{
                "name":"Version",
                "attribute":true
            }
        },
        "code":{
            "type":"string",
            "xml":{
                "name":"Code",
                "attribute":true
            }
        }
    },
    "description":"Optional external question metadata reference."
}

Nested Schema : MeasurementUnitRef

Type: array

List of measurement units referenced by this item.

Show Source

• Array of: object MeasurementUnitRef

{
    "type":"array",
    "description":"List of measurement units referenced by this item.",
    "xml":{
        "name":"MeasurementUnitRef"
    },
    "items":{
        "$ref":"#/components/schemas/MeasurementUnitRef"
    }
}

Nested Schema : Question

Type: object

Primary question text associated with the ItemDef.

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• translatedText(required): array TranslatedText

{
    "required":[
        "translatedText"
    ],
    "type":"object",
    "properties":{
        "translatedText":{
            "type":"array",
            "xml":{
                "name":"TranslatedText"
            },
            "items":{
                "$ref":"#/components/schemas/TranslatedText"
            }
        }
    },
    "description":"Primary question text associated with the ItemDef."
}

Nested Schema : RangeCheck

Type: array

Validation constraints for values of this item.

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• Array of: object RangeCheck
  Validation constraints for values of this item.

{
    "type":"array",
    "description":"Validation constraints for values of this item.",
    "xml":{
        "name":"RangeCheck"
    },
    "items":{
        "$ref":"#/components/schemas/RangeCheck"
    }
}

Nested Schema : Role

Type: array

Roles associated with this item.

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• Array of: object Role
  Roles associated with this item.

{
    "type":"array",
    "description":"Roles associated with this item.",
    "xml":{
        "name":"Role"
    },
    "items":{
        "$ref":"#/components/schemas/Role"
    }
}

Nested Schema : MeasurementUnitRef

Type: object

Show Source

• measurementUnitOID: string

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

Nested Schema : TranslatedText

Type: array

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• Array of: object TranslatedText
  Localized text value with associated language code.

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

Nested Schema : RangeCheck

Type: object

Validation constraints for values of this item.

Show Source

• checkValue: array CheckValue
• comparator: string
  Allowed Values: [ "LT", "LE", "GT", "GE", "EQ", "NE", "IN", "NOTIN" ]
• errorMessage: object ErrorMessage
• formalExpression: array FormalExpression
• measurementUnitRef: object MeasurementUnitRef
• softHard: string
  Allowed Values: [ "SOFT", "HARD" ]

{
    "type":"object",
    "properties":{
        "checkValue":{
            "type":"array",
            "xml":{
                "name":"CheckValue"
            },
            "items":{
                "$ref":"#/components/schemas/CheckValue"
            }
        },
        "formalExpression":{
            "type":"array",
            "xml":{
                "name":"FormalExpression"
            },
            "items":{
                "$ref":"#/components/schemas/FormalExpression"
            }
        },
        "measurementUnitRef":{
            "$ref":"#/components/schemas/MeasurementUnitRef"
        },
        "errorMessage":{
            "$ref":"#/components/schemas/ErrorMessage"
        },
        "comparator":{
            "type":"string",
            "xml":{
                "name":"Comparator",
                "attribute":true
            },
            "enum":[
                "LT",
                "LE",
                "GT",
                "GE",
                "EQ",
                "NE",
                "IN",
                "NOTIN"
            ]
        },
        "softHard":{
            "type":"string",
            "xml":{
                "name":"SoftHard",
                "attribute":true
            },
            "enum":[
                "SOFT",
                "HARD"
            ]
        }
    },
    "description":"Validation constraints for values of this item."
}

Nested Schema : CheckValue

Type: array

Show Source

• Array of: object CheckValue

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

Nested Schema : ErrorMessage

Type: object

Show Source

• translatedText(required): array TranslatedText

{
    "required":[
        "translatedText"
    ],
    "type":"object",
    "properties":{
        "translatedText":{
            "type":"array",
            "xml":{
                "name":"TranslatedText"
            },
            "items":{
                "$ref":"#/components/schemas/TranslatedText"
            }
        }
    }
}

Nested Schema : FormalExpression

Type: array

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• Array of: object FormalExpression
  Expression representing method logic in a specific execution context or language.

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

Nested Schema : CheckValue

Type: object

Show Source

• value: string

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

Nested Schema : TranslatedText

Type: array

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• Array of: object TranslatedText
  Localized text value with associated language code.

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

Nested Schema : Role

Type: object

Roles associated with this item.

Show Source

• value: string

{
    "type":"object",
    "properties":{
        "value":{
            "type":"string"
        }
    },
    "description":"Roles associated with this item."
}

Nested Schema : ItemGroupDef

Type: object

Item group definition aggregating item references, attributes, and metadata.

Show Source

• alias: array Alias
  Aliases providing cross-references, e.g., to SDTM.
• comment: string
  Optional comment.

  Example: Demographics group
• description: object Description
  Localized description containing one or more translated text entries.
• domain: string
  Domain value used in SDTM mapping.

  Example: DM
• isReferenceData: string
  Allowed Values: [ "YES", "NO", "Yes", "No" ]

  Represents a Yes or No value.

  Example: Yes
• itemRef: array ItemRef
  References to items included in this group.
• name: string
  Display name of the item group.

  Example: Demographics
• oid: string
  Object identifier for the ItemGroupDef.

  Example: IG.DEMO
• origin: string
  Origin of the data represented by this group (e.g., Collected, Derived).

  Example: Collected
• purpose: string
  Purpose of this item group.

  Example: CRF
• repeating: string
  Allowed Values: [ "YES", "NO", "Yes", "No" ]

  Represents a Yes or No value.

  Example: Yes
• role: string
  Role of this group within the form.

  Example: Form
• sasdatasetName: string

{
    "type":"object",
    "properties":{
        "description":{
            "$ref":"#/components/schemas/Description"
        },
        "itemRef":{
            "type":"array",
            "description":"References to items included in this group.",
            "xml":{
                "name":"ItemRef"
            },
            "items":{
                "$ref":"#/components/schemas/ItemRef"
            }
        },
        "alias":{
            "type":"array",
            "description":"Aliases providing cross-references, e.g., to SDTM.",
            "xml":{
                "name":"Alias"
            },
            "items":{
                "$ref":"#/components/schemas/Alias"
            }
        },
        "oid":{
            "type":"string",
            "description":"Object identifier for the ItemGroupDef.",
            "example":"IG.DEMO",
            "xml":{
                "name":"OID",
                "attribute":true
            }
        },
        "name":{
            "type":"string",
            "description":"Display name of the item group.",
            "example":"Demographics",
            "xml":{
                "name":"Name",
                "attribute":true
            }
        },
        "repeating":{
            "type":"string",
            "description":"Represents a Yes or No value.",
            "example":"Yes",
            "xml":{
                "name":"Repeating",
                "attribute":true
            },
            "enum":[
                "YES",
                "NO",
                "Yes",
                "No"
            ]
        },
        "isReferenceData":{
            "type":"string",
            "description":"Represents a Yes or No value.",
            "example":"Yes",
            "xml":{
                "name":"IsReferenceData",
                "attribute":true
            },
            "enum":[
                "YES",
                "NO",
                "Yes",
                "No"
            ]
        },
        "domain":{
            "type":"string",
            "description":"Domain value used in SDTM mapping.",
            "example":"DM",
            "xml":{
                "name":"Domain",
                "attribute":true
            }
        },
        "origin":{
            "type":"string",
            "description":"Origin of the data represented by this group (e.g., Collected, Derived).",
            "example":"Collected",
            "xml":{
                "name":"Origin",
                "attribute":true
            }
        },
        "role":{
            "type":"string",
            "description":"Role of this group within the form.",
            "example":"Form",
            "xml":{
                "name":"Role",
                "attribute":true
            }
        },
        "purpose":{
            "type":"string",
            "description":"Purpose of this item group.",
            "example":"CRF",
            "xml":{
                "name":"Purpose",
                "attribute":true
            }
        },
        "comment":{
            "type":"string",
            "description":"Optional comment.",
            "example":"Demographics group",
            "xml":{
                "name":"Comment",
                "attribute":true
            }
        },
        "sasdatasetName":{
            "type":"string"
        }
    },
    "description":"Item group definition aggregating item references, attributes, and metadata.",
    "example":"<ItemGroupDef OID=\"IG.DEMO\" Name=\"Demographics\" Repeating=\"No\" IsReferenceData=\"No\" SASDatasetName=\"DM\" Domain=\"DM\" Origin=\"Collected\" Role=\"Form\" Purpose=\"CRF\" Comment=\"Demographics group\"><Description>Demographics item group</Description><ItemRef ItemOID=\"IT.AGE\" Mandatory=\"Yes\" OrderNumber=\"1\"/><ItemRef ItemOID=\"IT.SEX\" Mandatory=\"Yes\" OrderNumber=\"2\"/><Alias Context=\"SDTM\" Name=\"DMIG\"/></ItemGroupDef>",
    "xml":{
        "name":"ItemGroupDef",
        "namespace":"http://www.cdisc.org/ns/odm/v1.3"
    }
}

Example:

<ItemGroupDef OID="IG.DEMO" Name="Demographics" Repeating="No" IsReferenceData="No" SASDatasetName="DM" Domain="DM" Origin="Collected" Role="Form" Purpose="CRF" Comment="Demographics group"><Description>Demographics item group</Description><ItemRef ItemOID="IT.AGE" Mandatory="Yes" OrderNumber="1"/><ItemRef ItemOID="IT.SEX" Mandatory="Yes" OrderNumber="2"/><Alias Context="SDTM" Name="DMIG"/></ItemGroupDef>

Nested Schema : Alias

Type: array

Aliases providing cross-references, e.g., to SDTM.

Show Source

• Array of: object Alias
  Alternative naming context and value for an ODM element.

{
    "type":"array",
    "description":"Aliases providing cross-references, e.g., to SDTM.",
    "xml":{
        "name":"Alias"
    },
    "items":{
        "$ref":"#/components/schemas/Alias"
    }
}

Nested Schema : ItemRef

Type: array

References to items included in this group.

Show Source

• Array of: object ITEMREF

{
    "type":"array",
    "description":"References to items included in this group.",
    "xml":{
        "name":"ItemRef"
    },
    "items":{
        "$ref":"#/components/schemas/ItemRef"
    }
}

Nested Schema : ITEMREF

Type: object

Show Source

• controlRef(required): object CONTROLREF
• guid: string
• refName: string
• revision: number (float)

{
    "required":[
        "controlRef"
    ],
    "type":"object",
    "properties":{
        "controlRef":{
            "$ref":"#/components/schemas/ControlRef"
        },
        "guid":{
            "type":"string",
            "xml":{
                "name":"GUID",
                "attribute":true
            }
        },
        "revision":{
            "type":"number",
            "format":"float",
            "xml":{
                "name":"REVISION",
                "attribute":true
            }
        },
        "refName":{
            "type":"string",
            "xml":{
                "name":"REFNAME",
                "attribute":true
            }
        }
    },
    "xml":{
        "name":"ITEMREF",
        "namespace":"http://www.oracle.com/InFormAdapter/2011/10/Coding"
    }
}

Nested Schema : CONTROLREF

Type: object

Show Source

• controlRef: object CONTROLREF
• guid: string
• refName: string
• revision: number (float)

{
    "type":"object",
    "properties":{
        "controlRef":{
            "$ref":"#/components/schemas/ControlRef"
        },
        "guid":{
            "type":"string",
            "xml":{
                "name":"GUID",
                "attribute":true
            }
        },
        "revision":{
            "type":"number",
            "format":"float",
            "xml":{
                "name":"REVISION",
                "attribute":true
            }
        },
        "refName":{
            "type":"string",
            "xml":{
                "name":"REFNAME",
                "attribute":true
            }
        }
    },
    "xml":{
        "name":"CONTROLREF",
        "namespace":"http://www.oracle.com/InFormAdapter/2011/10/Coding"
    }
}

Nested Schema : MethodDef

Type: object

Definition of a computation or derivation used within the ODM metadata, including description, formal expressions, aliases, and attributes.

Show Source

• alias: array Alias
  Aliases providing alternative names in different contexts.
• description(required): object Description
  Localized description containing one or more translated text entries.
• formalExpression: array FormalExpression
  One or more formal expressions describing the method logic and its execution context.
• name: string
  Human-readable method name.

  Example: DoseComputation
• oid: string
  Unique identifier for the method within the ODM metadata.

  Example: MD.METH001
• type: string
  Allowed Values: [ "COMPUTATION", "IMPUTATION", "TRANSPOSE", "OTHER", "Computation", "Imputation", "Transpose", "Other" ]

  Classification of the method.

{
    "required":[
        "description"
    ],
    "type":"object",
    "properties":{
        "description":{
            "$ref":"#/components/schemas/Description"
        },
        "formalExpression":{
            "type":"array",
            "description":"One or more formal expressions describing the method logic and its execution context.",
            "xml":{
                "name":"FormalExpression"
            },
            "items":{
                "$ref":"#/components/schemas/FormalExpression"
            }
        },
        "alias":{
            "type":"array",
            "description":"Aliases providing alternative names in different contexts.",
            "xml":{
                "name":"Alias"
            },
            "items":{
                "$ref":"#/components/schemas/Alias"
            }
        },
        "oid":{
            "type":"string",
            "description":"Unique identifier for the method within the ODM metadata.",
            "example":"MD.METH001",
            "xml":{
                "name":"OID",
                "attribute":true
            }
        },
        "name":{
            "type":"string",
            "description":"Human-readable method name.",
            "example":"DoseComputation",
            "xml":{
                "name":"Name",
                "attribute":true
            }
        },
        "type":{
            "type":"string",
            "description":"Classification of the method.",
            "xml":{
                "name":"Type",
                "attribute":true
            },
            "enum":[
                "COMPUTATION",
                "IMPUTATION",
                "TRANSPOSE",
                "OTHER",
                "Computation",
                "Imputation",
                "Transpose",
                "Other"
            ]
        }
    },
    "description":"Definition of a computation or derivation used within the ODM metadata, including description, formal expressions, aliases, and attributes.",
    "example":"<MethodDef OID=\"MD.METH001\" Name=\"DoseComputation\" Type=\"Computation\">\n  <Description>\n    <TranslatedText xml:lang=\"en\">Compute derived dose based on weight and concentration</TranslatedText>\n  </Description>\n  <FormalExpression Context=\"SAS\">if (WEIGHT GT 0) then DOSE=WEIGHT*CONC; else DOSE=.;</FormalExpression>\n <Alias Context=\"CDISC\" Name=\"DRVDose\"/>\n</MethodDef>"
}

Example:

<MethodDef OID="MD.METH001" Name="DoseComputation" Type="Computation">
  <Description>
    <TranslatedText xml:lang="en">Compute derived dose based on weight and concentration</TranslatedText>
  </Description>
  <FormalExpression Context="SAS">if (WEIGHT GT 0) then DOSE=WEIGHT*CONC; else DOSE=.;</FormalExpression>
 <Alias Context="CDISC" Name="DRVDose"/>
</MethodDef>

Nested Schema : Alias

Type: array

Aliases providing alternative names in different contexts.

Show Source

• Array of: object Alias
  Alternative naming context and value for an ODM element.

{
    "type":"array",
    "description":"Aliases providing alternative names in different contexts.",
    "xml":{
        "name":"Alias"
    },
    "items":{
        "$ref":"#/components/schemas/Alias"
    }
}

Nested Schema : FormalExpression

Type: array

One or more formal expressions describing the method logic and its execution context.

Show Source

• Array of: object FormalExpression
  Expression representing method logic in a specific execution context or language.

{
    "type":"array",
    "description":"One or more formal expressions describing the method logic and its execution context.",
    "xml":{
        "name":"FormalExpression"
    },
    "items":{
        "$ref":"#/components/schemas/FormalExpression"
    }
}

Nested Schema : Presentation

Type: object

Presentation element containing display text and metadata.

Show Source

• lang: string (language)
  Language code per IETF BCP 47 (xml:lang).

  Example: en
• oid: string
  Object identifier for the Presentation element.

  Example: PRES001
• value: string
  Presentation text content.

  Example: Tablet, 50 mg

{
    "type":"object",
    "properties":{
        "value":{
            "type":"string",
            "description":"Presentation text content.",
            "example":"Tablet, 50 mg"
        },
        "oid":{
            "type":"string",
            "description":"Object identifier for the Presentation element.",
            "example":"PRES001",
            "xml":{
                "name":"OID",
                "attribute":true
            }
        },
        "lang":{
            "type":"string",
            "description":"Language code per IETF BCP 47 (xml:lang).",
            "format":"language",
            "example":"en",
            "xml":{
                "namespace":"http://www.w3.org/XML/1998/namespace",
                "attribute":true
            }
        }
    },
    "description":"Presentation element containing display text and metadata.",
    "example":"<Presentation OID=\"PRES001\" xml:lang=\"en\">Tablet, 50 mg</Presentation>"
}

Example:

<Presentation OID="PRES001" xml:lang="en">Tablet, 50 mg</Presentation>

Nested Schema : Alias

Type: array

Optional aliases for the protocol.

Show Source

• Array of: object Alias
  Alternative naming context and value for an ODM element.

{
    "type":"array",
    "description":"Optional aliases for the protocol.",
    "xml":{
        "name":"Alias"
    },
    "items":{
        "$ref":"#/components/schemas/Alias"
    }
}

Nested Schema : StudyEventRef

Type: array

References to study events that constitute the schedule of assessments.

Show Source

• Array of: object StudyEventRef
  Reference to a study event within the protocol schedule, including ordering and mandatory collection attributes.

{
    "type":"array",
    "description":"References to study events that constitute the schedule of assessments.",
    "xml":{
        "name":"StudyEventRef"
    },
    "items":{
        "$ref":"#/components/schemas/StudyEventRef"
    }
}

Nested Schema : StudyEventRef

Type: object

Reference to a study event within the protocol schedule, including ordering and mandatory collection attributes.

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• collectionExceptionConditionOID: string
  Optional condition OID that defines exceptions for data collection.

  Example: COND_001
• mandatory: string
  Allowed Values: [ "YES", "NO", "Yes", "No" ]

  Represents a Yes or No value.

  Example: Yes
• orderNumber: integer (int32)
  Order number of the study event within the schedule.

  Example: 1
• studyEventOID: string
  OID of the referenced StudyEventDef.

  Example: SE_VISIT1

{
    "type":"object",
    "properties":{
        "studyEventOID":{
            "type":"string",
            "description":"OID of the referenced StudyEventDef.",
            "example":"SE_VISIT1",
            "xml":{
                "name":"StudyEventOID",
                "attribute":true
            }
        },
        "orderNumber":{
            "type":"integer",
            "description":"Order number of the study event within the schedule.",
            "format":"int32",
            "example":1,
            "xml":{
                "name":"OrderNumber",
                "attribute":true
            }
        },
        "mandatory":{
            "type":"string",
            "description":"Represents a Yes or No value.",
            "example":"Yes",
            "xml":{
                "name":"Mandatory",
                "attribute":true
            },
            "enum":[
                "YES",
                "NO",
                "Yes",
                "No"
            ]
        },
        "collectionExceptionConditionOID":{
            "type":"string",
            "description":"Optional condition OID that defines exceptions for data collection.",
            "example":"COND_001",
            "xml":{
                "name":"CollectionExceptionConditionOID",
                "attribute":true
            }
        }
    },
    "description":"Reference to a study event within the protocol schedule, including ordering and mandatory collection attributes.",
    "example":{
        "studyEventOID":"SE_VISIT1",
        "orderNumber":1,
        "mandatory":"Yes",
        "collectionExceptionConditionOID":"COND_001"
    }
}

Example:

{
    "studyEventOID":"SE_VISIT1",
    "orderNumber":1,
    "mandatory":"Yes",
    "collectionExceptionConditionOID":"COND_001"
}

Nested Schema : StudyEventDef

Type: object

Study event definition containing form references, scheduling attributes, and metadata.

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• alias: array Alias
  Aliases providing cross-references (e.g., SDTM).
• category: string
  Optional category for the event.

  Example: Screening
• description: object Description
  Localized description containing one or more translated text entries.
• formRef: array FormRef
  References to forms associated with this study event.
• name: string
  Display name of the study event.

  Example: Visit 1
• oid: string
  Object identifier for the StudyEventDef.

  Example: SE.VISIT1
• repeating: string
  Allowed Values: [ "YES", "NO", "Yes", "No" ]

  Represents a Yes or No value.

  Example: Yes
• type: string
  Allowed Values: [ "SCHEDULED", "UNSCHEDULED", "COMMON" ]

  Type of study event (e.g., Scheduled, Unscheduled).

  Example: Scheduled

{
    "type":"object",
    "properties":{
        "description":{
            "$ref":"#/components/schemas/Description"
        },
        "formRef":{
            "type":"array",
            "description":"References to forms associated with this study event.",
            "xml":{
                "name":"FormRef"
            },
            "items":{
                "$ref":"#/components/schemas/FormRef"
            }
        },
        "alias":{
            "type":"array",
            "description":"Aliases providing cross-references (e.g., SDTM).",
            "xml":{
                "name":"Alias"
            },
            "items":{
                "$ref":"#/components/schemas/Alias"
            }
        },
        "oid":{
            "type":"string",
            "description":"Object identifier for the StudyEventDef.",
            "example":"SE.VISIT1",
            "xml":{
                "name":"OID",
                "attribute":true
            }
        },
        "name":{
            "type":"string",
            "description":"Display name of the study event.",
            "example":"Visit 1",
            "xml":{
                "name":"Name",
                "attribute":true
            }
        },
        "repeating":{
            "type":"string",
            "description":"Represents a Yes or No value.",
            "example":"Yes",
            "xml":{
                "name":"Repeating",
                "attribute":true
            },
            "enum":[
                "YES",
                "NO",
                "Yes",
                "No"
            ]
        },
        "type":{
            "type":"string",
            "description":"Type of study event (e.g., Scheduled, Unscheduled).",
            "example":"Scheduled",
            "xml":{
                "name":"Type",
                "attribute":true
            },
            "enum":[
                "SCHEDULED",
                "UNSCHEDULED",
                "COMMON"
            ]
        },
        "category":{
            "type":"string",
            "description":"Optional category for the event.",
            "example":"Screening",
            "xml":{
                "name":"Category",
                "attribute":true
            }
        }
    },
    "description":"Study event definition containing form references, scheduling attributes, and metadata.",
    "example":"<StudyEventDef OID=\"SE.VISIT1\" Name=\"Visit 1\" Repeating=\"No\" Type=\"Scheduled\" Category=\"Screening\"><Description>Initial screening visit</Description><FormRef FormOID=\"FRM.DEMO\" Mandatory=\"Yes\" OrderNumber=\"1\"/><Alias Context=\"SDTM\" Name=\"SV\"/></StudyEventDef>",
    "xml":{
        "name":"StudyEventDef",
        "namespace":"http://www.cdisc.org/ns/odm/v1.3"
    }
}

Example:

<StudyEventDef OID="SE.VISIT1" Name="Visit 1" Repeating="No" Type="Scheduled" Category="Screening"><Description>Initial screening visit</Description><FormRef FormOID="FRM.DEMO" Mandatory="Yes" OrderNumber="1"/><Alias Context="SDTM" Name="SV"/></StudyEventDef>

Nested Schema : Alias

Type: array

Aliases providing cross-references (e.g., SDTM).

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• Array of: object Alias
  Alternative naming context and value for an ODM element.

{
    "type":"array",
    "description":"Aliases providing cross-references (e.g., SDTM).",
    "xml":{
        "name":"Alias"
    },
    "items":{
        "$ref":"#/components/schemas/Alias"
    }
}

Nested Schema : FormRef

Type: array

References to forms associated with this study event.

Show Source

• Array of: object FORMREF

{
    "type":"array",
    "description":"References to forms associated with this study event.",
    "xml":{
        "name":"FormRef"
    },
    "items":{
        "$ref":"#/components/schemas/FormRef"
    }
}

Nested Schema : FORMREF

Type: object

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• guid: string
• name: string
• order: integer (int64)
• refName: string
• revision: number (float)
• sectionRef(required): object SECTIONREF

{
    "required":[
        "sectionRef"
    ],
    "type":"object",
    "properties":{
        "sectionRef":{
            "$ref":"#/components/schemas/SectionRef"
        },
        "guid":{
            "type":"string",
            "xml":{
                "name":"GUID",
                "attribute":true
            }
        },
        "revision":{
            "type":"number",
            "format":"float",
            "xml":{
                "name":"REVISION",
                "attribute":true
            }
        },
        "refName":{
            "type":"string",
            "xml":{
                "name":"REFNAME",
                "attribute":true
            }
        },
        "name":{
            "type":"string",
            "xml":{
                "name":"NAME",
                "attribute":true
            }
        },
        "order":{
            "type":"integer",
            "format":"int64",
            "xml":{
                "name":"ORDER",
                "attribute":true
            }
        }
    },
    "xml":{
        "name":"FORMREF",
        "namespace":"http://www.oracle.com/InFormAdapter/2011/10/Coding"
    }
}

Nested Schema : SECTIONREF

Type: object

Show Source

• guid: string
• itemRef: object ITEMREF
• itemSetRef: object ITEMSETREF
• refName: string
• revision: number (float)

{
    "type":"object",
    "properties":{
        "itemRef":{
            "$ref":"#/components/schemas/ItemRef"
        },
        "itemSetRef":{
            "$ref":"#/components/schemas/ItemSetRef"
        },
        "guid":{
            "type":"string",
            "xml":{
                "name":"GUID",
                "attribute":true
            }
        },
        "revision":{
            "type":"number",
            "format":"float",
            "xml":{
                "name":"REVISION",
                "attribute":true
            }
        },
        "refName":{
            "type":"string",
            "xml":{
                "name":"REFNAME",
                "attribute":true
            }
        }
    },
    "xml":{
        "name":"SECTIONREF",
        "namespace":"http://www.oracle.com/InFormAdapter/2011/10/Coding"
    }
}

Nested Schema : ITEMSETREF

Type: object

Show Source

• guid: string
• itemRef(required): object ITEMREF
• order: integer (int64)
• refName: string
• revision: number (float)

{
    "required":[
        "itemRef"
    ],
    "type":"object",
    "properties":{
        "itemRef":{
            "$ref":"#/components/schemas/ItemRef"
        },
        "guid":{
            "type":"string",
            "xml":{
                "name":"GUID",
                "attribute":true
            }
        },
        "revision":{
            "type":"number",
            "format":"float",
            "xml":{
                "name":"REVISION",
                "attribute":true
            }
        },
        "refName":{
            "type":"string",
            "xml":{
                "name":"REFNAME",
                "attribute":true
            }
        },
        "order":{
            "type":"integer",
            "format":"int64",
            "xml":{
                "name":"ORDER",
                "attribute":true
            }
        }
    },
    "xml":{
        "name":"ITEMSETREF",
        "namespace":"http://www.oracle.com/InFormAdapter/2011/10/Coding"
    }
}

400 Response

'Missing / invalid data'

Body ()

Root Schema : DataHubResponse

Type: object

Standard Data Hub response envelope.

Successful responses return status as "success" and populate result. Failed responses return status as "failed" and populate errorData.

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• errorData: object errorData

  Machine-readable error payload when status is "failed".

  This field is null when status is "success".

• result: object result

  Payload returned by the API when status is "success".

  This field is null when status is "failed".

• status: string

  Overall request processing status.

  Allowed values are "success" and "failed".

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

  Example: 1

{
    "type":"object",
    "properties":{
        "status":{
            "type":"string",
            "description":"<p>Overall request processing status.</p><p>Allowed values are \"success\" and \"failed\".</p>",
            "example":"success"
        },
        "result":{
            "type":"object",
            "description":"<p>Payload returned by the API when <code>status</code> is \"success\".</p><p>This field is null when <code>status</code> is \"failed\".</p>",
            "example":{
                "message":"Operation succeeded"
            }
        },
        "errorData":{
            "type":"object",
            "description":"<p>Machine-readable error payload when <code>status</code> is \"failed\".</p><p>This field is null when <code>status</code> is \"success\".</p>",
            "example":{
                "errorCode":"VALIDATION_ERROR",
                "errorMessage":"Invalid column name specified in the select columns: SITE_ID1",
                "details":{
                    "field":"selectColumns"
                }
            }
        },
        "version":{
            "type":"integer",
            "description":"Envelope version number.",
            "format":"int32",
            "example":1
        }
    },
    "description":"<p>Standard Data Hub response envelope.</p><p>Successful responses return <code>status</code> as \"success\" and populate <code>result</code>. Failed responses return <code>status</code> as \"failed\" and populate <code>errorData</code>.</p>"
}

Nested Schema : errorData

Type: object

Machine-readable error payload when status is "failed".

This field is null when status is "success".

Example:

{
    "errorCode":"VALIDATION_ERROR",
    "errorMessage":"Invalid column name specified in the select columns: SITE_ID1",
    "details":{
        "field":"selectColumns"
    }
}

Nested Schema : result

Type: object

Payload returned by the API when status is "success".

This field is null when status is "failed".

Example:

{
    "message":"Operation succeeded"
}

Examples

Select an example ErrorResponseExample

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