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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.
| Attribute | Usage | Description | Attribute order |
|---|---|---|---|
| fileOID | Required | A unique identifier for this file. | 0 |
| creationDateTime | Required | Time of creation of the file containing the document. | 1 |
| asOfDateTime | Required | The date/time at which the source database was queried in order to create this document. | 2 |
| originator | Optional | The organization that generated the ODM file. | 3 |
| sourceSystem | Optional | The computer system or database management system that is the source of the information in this file. | 4 |
| sourceSystemVersion | Optional | The version of the "SourceSystem" above. | 5 |
| datasetJSONVersion | Required | Version of Dataset-JSON standard | 6 |
| clinicalData | Required | See ODM definition for study OID (STUDYOID). | 7 |
| referenceData | Required | See ODM definition for metadata version OID (METADATAVERSIONOID). | 8 |
| Code Block | ||
|---|---|---|
| ||
{
"fileOID": "www.sponsor.xyz.org.project123.final",
"creationDateTime": "2023-03-22T11:53:27",
"asOfDateTime": "2023-02-15T10:23:15",
"originator": "Sponsor XYZ",
"sourceSystem": "Software ABC",
"sourceSystemVersion": "1.0.0",
"datasetJSONVersion": "",
"clinicalData": { ... },
"referenceData": { ... }
} |
ClinicalData and ReferenceData Attributes
Both clinicalData and referenceData have the same structure. Each of these attributes contains study and metadata OIDs as well as an object describing an item group (dataset). The following attributes are defined on this level
| Attribute | Requirement | Description | Attribute order |
|---|---|---|---|
| studyOID | Required | See ODM definition for study OID (STUDYOID). | 0 |
| metaDataVersionOID | Required | See ODM definition for metadata version OID (METADATAVERSIONOID). | 1 |
| itemGroupData | Required | Object containing dataset information | 2 |
Values of the studyOID and metaDataVersionOID must match corresponding values in the Define-XML file.
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