...
| 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 ODM 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 | OptionalSee | ODM definition for study OID (STUDYOID)Contains datasets for clinical data across multiple subjects. | 8 |
| referenceData | OptionalSee | ODM definition for metadata version OID (METADATAVERSIONOID)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",
"originator": "Sponsor XYZ",
"sourceSystem": "Software ABC",
"sourceSystemVersion": "1.0.0",
"datasetJSONVersion": "",
"clinicalData": { ... },
"referenceData": { ... }
} |
...
| Attribute | Requirement | Description | Attribute order |
|---|---|---|---|
| studyOID | Required | See ODM definition for study OID (STUDYOIDODM/Study/@OID). | 1 |
| metaDataVersionOID | Required | See ODM definition for metadata version OID (METADATAVERSIONOIDODM/Study/MetaDataVersion/@OID). | 2 |
| metaDataRef | Optional | URL for a metadata file the describing the data. | 3 |
| itemGroupData | Required | Object containing dataset information | 4 |
...
itemGroupData is an object with a single attribute corresponding to an individual dataset. The attribute name is OID of a described dataset, which must be the same as the OID of the corresponding itemGroup itemGroupDef in the Define-XML file.
| Code Block | ||
|---|---|---|
| ||
"itemGroupData": {
"IG.DM": { ... }
}
|
...
| Attribute | Requirement | Description | Attribute order |
|---|---|---|---|
| OID | Required | OID of a variable (must correspond to the variable OID in the Define-XML file) | 1 |
| name | Required | Variable name | 2 |
label | Required | Variable description | 3 |
| type | Required | Type of the variable (i.e., . Allowed values: "string", "integer", "decimal", "float", "double", "boolean"; see . See ODM types for details). | 4 |
| length | Optional | Variable length | 5 |
| displayFormat | Optional | Display format supports data visualization of numeric float and date values. | 6 |
| keySequence | Optional | Indicates that this item is a key variable in the dataset structure. It also provides an ordering for the keys. | 7 |
...
| Code Block | ||
|---|---|---|
| ||
{
"fileOID": "www.sponsor.org.project123.final",
"creationDateTime": "2023-03-22T11:53:27",
"asOfDateTime": "2023-02-15T10:23:15",
"originatordatasetJSONVersion": "Sponsor XYZ1.0.0",
"sourceSystemoriginator": "SoftwareSponsor ABCXYZ",
"sourceSystemVersionsourceSystem": "1.2.3Software ABC",
"datasetJSONVersionsourceSystemVersion": "1.02.03",
"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],
...
]
}
}
},
} |
...