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  • OID - OID of a variable (must correspond to the variable OID in the Define-XML file)
  • name - variable name
  • label - variable description
  • type - type of the variable. One of 'string', 'integer', 'float', 'double', 'decimal', 'boolean'. See ODM types for details.
  • length - variable length
  • fractionDigits - Number of digits to the right of the decimal point when type of the variable is float

...

Code Block
languagejs
{
    "clinicalData": {
        "studyOID": "xxx",
        "metaDataVersionOID": "xxx",
        "itemGroupData": {
            "IG.DM": {
                "records": 600,
                "name": "DM",
                "label": "Demographics",
                "items": [
                    {"OID": "ITEMGROUPDATASEQ", "name": "ITEMGROUPDATASEQ", "label": "Record identifier", "type": "integer"},
                    {"OID": "IT.STUDYID", "name": "STUDYID", "label": "Study identifier", "type": "string", "length": 712}, 
                    {"OID": "IT.USUBJID", "name": "USUBJID", "label": "Unique Subject Identifier", "type": "string", "length": 3}, 
                    {"OID": "IT.DOMAIN", "name": "DOMAIN", "label": "Domain Identifier", "type": "string", "length": 2},
                    {"OID": "IT.AGE", "name": "AGE", "label": "Subject Age", "type": "float", "length": 5, "fractionDigits": 2}
                ],
                "itemData": [
                    [1, "MyStudy", "001", "DM", 56],
                    [2, "MyStudy", "002", "DM", 26],
                    ...
                ]
            }
        }
    },
    "referenceData": {
        ... Same structure as clinical data
    }
}

...

  • OID - OID of a variable (must correspond to the variable OID in the Define-XML file)
  • name - variable name
  • label - variable description
  • type - type of the variable. One of 'string', 'integer', 'float', 'double', 'boolean'. See ODM types for details.
  • length - variable length
  • fractionDigits - Number of digits to the right of the decimal point when type of the variable is float

Code Block
languagejs
"items": [    
    {
        "OID": 100"ITEMGROUPDATASEQ",
        "name": "DMITEMGROUPDATASEQ",
        "label": "DemographicsRecord identifier",
        "type": "floatinteger",
		"length": 10,
		"fractiondigits": 3
    },
    {
        "OID": "IT.DM.STUDYID",
        "name": "STUDYID",
        "label": "Study Identifier",
        "type": "string",
        "length": 12
    },
    ...
]

itemData is an array of records with variables values. Each record itself is also represented as an array of variables values.

Code Block
languagejs
"itemData": {
   [1, "MyStudy", "001", "DM", 56],
   [2, "MyStudy", "002", "DM", 26],
}

...

Code Block
languagejs
{
    "clinicalData": {
        "studyOID": "xxx",
        "metaDataVersionOID": "xxx",
        "itemGroupData": {
            "IG.DM": {
                "records": 600,
                "name": "DM",
                "label": "Demographics",
",
                "items": [                      
                    {"itemsOID": [
                   "ITEMGROUPDATASEQ", "name": "ITEMGROUPDATASEQ", "label": "Record identifier", "type": "integer"},
                    {"OID": "IT.STUDYID", "name": "STUDYID", "label": "Study identifier", "type": "string", "length": 7}, 
                    {"OID": "IT.USUBJID", "name": "USUBJID", "label": "Unique Subject Identifier", "type": "string", "length": 3}, 
                    {"OID": "IT.DOMAIN", "name": "DOMAIN", "label": "Domain Identifier", "type": "string", "length": 2},
                    {"OID": "IT.AGE", "name": "AGE", "label": "Subject Age", "type": "float", "length": 5, "fractiondigits": 2}
                ],
                "itemData": [
                    [1, "MyStudy", "001", "DM", 56],
                    [2, "MyStudy", "002", "DM", 26],
                    ...
                ]
            }
        }
    },
    "referenceData": {
        ... Same structure as clinical data
    }
}

...