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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".


Code Block
languagejs
titleExample of ODM v2.0 JSON prologfile
{
    "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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