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Info

Example of prolog and top-level ODM v2.0 XML element:


Code Block
languagexml
titleExample of prolog and top-level ODM v2.0 XML element
<?xml version="1.0" encoding="UTF-8"?>
<ODM xmlns="http://www.cdisc.org/ns/odm/v2.0"
    xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"
 
    xsi:schemaLocation="http://www.cdisc.org/ns/odm/v2.0 ODM2-0-0.xsd"
 
    ODMVersion="2.0"
    FileOID="000-00-0000"
    FileType="Transactional"
    Description="Sample ItemData Extension"
 
    AsOfDateTime="2022-06-04T07:57:00"
    CreationDateTime="2022-06-06T10:30:00">

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  1. The ODM file must be a well-formed JSON file. See the ECMA-404 standard for details.
  2. The ODM file must satisfy the rules about element nesting and the formats of values defined in the ODM standard.
  3. The root object corresponds to the ODM element.
  4. The ODMVersion attribute of the root object must be set to "2.0".


Info

Example of ODM v2.0 JSON prolog:


Code Block
titleExample of ODM v2.0 JSON prolog
{
    "clinicalData": {
        "studyOID": "cdisc.com/CDISCPILOT01",
        "metaDataVersionOID": "MDV.MSGv2.0.SDTMIG.3.3.SDTM.1.7",
        "itemGroupData": {
            "IG.DM": {
                "records": 18,
                "name": "DM",
                "label": "Demographics",
                "items": [ ...
                ],
                "itemData": [ ...
                ]
            }
        }
    }
}

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