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Dataset-JSON was adapted from the Dataset-XML Version 1.0 specification, but uses JSON format. Like Dataset-XML, each Dataset-JSON file is connected with a Define-XML file , containing detailed information about the metadata. One aim of Dataset-JSON is to address as many of the relevant requirements in the PHUSE 2017 Transport for the Next Generation paper as possible, including the efficient use of storage space.

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At the top level of Dataset-JSON object, there are two 2 optional attributes: clinicalData , and referenceData, corresponding to Dataset-XML elements. At least one 1 of the attribute attributes must be provided. Subject data is stored in clinicalData and non-subject data is stored in referenceData.

{
    "clinicalData": { ... },
    "referenceData": { ... }
}

Both clinicalData and referenceData have the same structure. Each of these attributes contains study and metadata OIDs as well as an object describing one 1 or more item groups (datasets). Values of the studyOID and metaDataVersionOID must match corresponding values in the Define-XML file.

{
    "clinicalData": {
        "studyOID": "xxx",
        "metaDataVersionOID": "xxx",
        "itemGroupData": { ... }
}

ItemGroupData attribute

itemGroupData is an object with attributes corresponding to individual datasets. The attribute name is OID of a described dataset, which must be the same as OID of the corresponding itemGroup in the Define-XML file.

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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'", '"decimal'", '"float'", 'double', 'boolean'. See ODM types for details.
• length - variable length

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