...
JSON format does not allow to specify or control order of attributes. Despite of that, as most JSON engines allow to control the order of attributes it is strongly recommended to follow the attribute order specified in details. The reason for that is that due to a possible large size of Dataset-JSON files, following the specified order will enable a software using steaming approaches to read the file to work in an efficient and fast way.
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.
| 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. | 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. | 3datasetJSONVersion | 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 "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": "2023-03-22T11:53:27"1.0.0",
"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": { ... }
} |
...
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 | RequiredOptional | See ODM definition for study OID (ODM/Study/@OID). | 1 |
| metaDataVersionOID | RequiredOptional | 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 |
...
itemGroupData is an object with a single attribute corresponding to an individual dataset. There must be only one dataset per Dataset-JSON file. The attribute name is OID of a described dataset, which must be the same as the OID of the corresponding itemGroupDef in the Define-XML file.
...
| 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]
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],
...
]
}
}
},
} |
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.
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