...
Dataset-JSON must contain only one dataset per file.
Top Level Attributes
At the top level of Dataset-JSON object, there are technical attributes and two main optional attributes: clinicalData and referenceData, corresponding to Dataset-XML elements. At least 1 of the main attributes must be provided. Subject data is stored in clinicalData and non-subject data is stored in referenceData.
...
Both clinicalData and referenceData have the same structure. Each of these attributes contains study and metadata OIDs, optional reference to the metadata file and an object describing an item group (dataset). The following attributes are defined on this level.
| Attribute | Requirement | Description | Attribute order |
|---|---|---|---|
| studyOID | Optional | See ODM definition for study OID (ODM/Study/@OID). | 1 |
| metaDataVersionOID | Optional | See ODM definition for metadata version OID (ODM/Study/MetaDataVersion/@OID). | 2 |
| metaDataRef | Optional | URL for a metadata file describing the data. | 3 |
| itemGroupData | Required | Object containing dataset information | 4 |
...
| Code Block | ||
|---|---|---|
| ||
"itemData": {[ [1, "MyStudy", "001", "DM", 56], [2, "MyStudy", "002", "DM", 26], } ... ] |
Missing values are represented by null in the case of numeric variables, and an empty string in case of character variables: [1, "MyStudy", "", "DM", null]
...
| Code Block | ||
|---|---|---|
| ||
{
"creationDateTime": "2023-03-22T11:53:27",
"datasetJSONVersion": "1.0.0",
"fileOID": "www.sponsor.org.project123.final",
"asOfDateTime": "2023-02-15T10:23:15",
"originator": "Sponsor XYZ",
"sourceSystem": "Software ABC",
"sourceSystemVersion": "1.2.3",
"clinicalData": {
"studyOID": "xxx",
"metaDataVersionOID": "xxx",
"metaDataRef": "https://metadata.location.org/api.link",
"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": 7, "keySequence": 1},
{"OID": "IT.USUBJID", "name": "USUBJID", "label": "Unique Subject Identifier", "type": "string", "length": 3, "keySequence": 2},
{"OID": "IT.DOMAIN", "name": "DOMAIN", "label": "Domain Identifier", "type": "string", "length": 2},
{"OID": "IT.AGE", "name": "AGE", "label": "Subject Age", "type": "integer", "length": 2}
],
"itemData": [
[1, "MyStudy", "001", "DM", 56],
[2, "MyStudy", "002", "DM", 26],
...
]
}
}
}
} |
The TypeScript model representation and the JSON schema for Dataset-JSON version 1.0 can be found at https://github.com/cdisc-org/DataExchange-DatasetJson.
| Pagenav2 |
|---|