...
| Attribute | Usage | Description | Attribute order |
|---|---|---|---|
| fileOID | Required | A unique identifier for this file. | 1 |
| creationDateTime | Required | Time of creation of the file containing the document. | 2 |
| asOfDateTime | Required | The date/time at which the source database was queried in order to create this document. | 3 |
| datasetJSONVersion | Required | Version of Dataset-JSON standard | 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 "SourceSystemsourceSystem" 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 | ||
|---|---|---|
| ||
{
"fileOID": "www.sponsor.xyz.org.project123.final",
"creationDateTime": "2023-03-22T11:53:27",
"asOfDateTime": "2023-02-15T10:23:15",
"datasetJSONVersion": "1.0.0",
"originator": "Sponsor XYZ",
"sourceSystem": "Software ABC",
"sourceSystemVersion": "1.0.0",
"clinicalData": { ... },
"referenceData": { ... }
} |
...
| Attribute | Requirement | Description | Attribute order |
|---|---|---|---|
| studyOID | Required | See ODM definition for study OID (ODM/Study/@OID). | 1 |
| metaDataVersionOID | Required | See ODM definition for metadata version OID (ODM/Study/MetaDataVersion/@OID). | 2 |
| metaDataRef | Optional | URL for a metadata file the describing the data. | 3 |
| itemGroupData | Required | Object containing dataset information | 4 |
...