Jira server Issue Tracker (JIRA) columnIds issuekey,summary,issuetype,created,updated,duedate,assignee,reporter,priority,status,resolution columns key,summary,type,created,updated,due,assignee,reporter,priority,status,resolution serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key ODM-75
Dataset-JSON was adapted from the Dataset-XML Version 1.0 specification, but uses JSON format. Like Dataset-XML, each Dataset-JSON file is connected with a Define-XML file containing detailed information about the metadata. One aim of Dataset-JSON is to address as many of the relevant requirements in the PHUSE 2017 Transport for the Next Generation paper as possible, including the efficient use of storage space.
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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.
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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 | Optional | See ODM definition for study OID (ODM/Study/@OID). | 1 |
| metaDataVersionOID | Optional | 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 |
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"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]
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{
"creationDateTime": "2023-03-22T11:53:27",
"datasetJSONVersion": "1.0.0",
"fileOID": "www.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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