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-76
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.
...
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.Jira
| Attribute | Usage | Description | Attribute order |
|---|---|---|---|
| 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. | 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 |
...
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
.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-78
| 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 |
...
The dataset description contains basic information about the dataset itself and its items.Jira
| Attribute | Requirement | Description | Attribute order |
|---|---|---|---|
| records | Required | The total number of records in a dataset | 1 |
| name | Required | Dataset name | 2 |
label | Required | Dataset description | 3 |
| items | Required | Basic information about variables | 4 |
| itemData | Required | Dataset data | 5 |
...
items is an array of basic information about dataset variables. The order of the elements in the array must be the same as the order of variables in the described dataset. The first element always describes the Record Identifier (ITEMGROUPDATASEQ). Jira
| 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. Allowed values: "string", "integer", "decimal", "float", "double", "boolean". 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 |
...
itemData is an array of records with variables values. Each record itself is also represented as an array of variables values. The first value is a unique sequence number for each record in the dataset.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
| 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]
...
| Code Block | ||
|---|---|---|
| ||
{
"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.
| Pagenav2 |
|---|