...
| Attribute | Usage | Description | Attribute order |
|---|---|---|---|
| creationDateTime | Required | Time of creation of the file containing the document. | 1 |
| datasetJSONVersion | Required | Version of Dataset-JSON standard | 2 |
| fileOID | Optional | A unique identifier for this file. | 3 |
| asOfDateTime | Optional | The date/time at which the source database was queried in order to create this document. | 4 |
| originator | Optional | The organization that generated the Dataset-JSON file. | 5 |
| sourceSystem | Optional | The computer system or database management system that is the source of the information in this file. | 6 |
| sourceSystemVersion | Optional | The version of the "sourceSystem" above. | 7 |
| clinicalData | Optional | Contains datasets for clinical data across multiple subjects. | 8 |
| referenceData | Optional | Contains datasets for non-subject data domains. | 9 |
| Code Block | ||
|---|---|---|
| ||
{
"fileOIDcreationDateTime": "www.sponsor.xyz.org.project123.final",2023-03-22T11:53:27",
"creationDateTimedatasetJSONVersion": "2023-03-22T11:53:271.0.0",
"fileOID": "www.sponsor.xyz.org.project123.final",
"asOfDateTime": "2023-02-15T10:23:15",
"datasetJSONVersion": "1.0.0",
"originator": "Sponsor XYZ",
"sourceSystem": "Software ABC",
"sourceSystemVersion": "1.0.0",
"clinicalData": { ... },
"referenceData": { ... }
} |
...
The following is a full example of a Dataset-JSON file:
| Code Block | ||
|---|---|---|
| ||
{
"fileOID": "www.sponsor.org.project123.final",
"creationDateTime": "2023-03-22T11:53:27",
"asOfDateTimedatasetJSONVersion": "2023-02-15T10:23:151.0.0",
"datasetJSONVersionfileOID": "1.0.0www.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],
...
]
}
}
}
} |
...