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titleNews and updates
  • 2023-04-04: Package 3 (package 2023-03-31)
  • 2023-02-13: Package 2 (package 2023-02-13)
  • 2022-12-07: Initial version (package 2022-10-26)

Table of Contents

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Introduction

Status
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titleUpdated
CDISC biomedical concepts and dataset specializations are currently supported standards. These include an abstract conceptual layer, aligned with NCI terminology, which is linked to a simplified implementation layer of pre-configured SDTM dataset specializations.Information for additional specializations, such as CDASH data collections, will be added when they become available. 

The biomedical concepts and dataset specializations are informative content. They will start to fill gaps such as semantics, variable relationships and value level metadata. Key objectives are to reduce variability in standards implementations, increase metadata-driven automation and reduce barriers to operational implementation. 

CDISC biomedical concepts and dataset specializations will be released in incremental packages. The first package was released on October 26, 2022.  Subsequent packages have been released and are now available via CDISC Library APIs (see News and Updates).

Please use CDISC Jira for comments and feedback.

...

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Example 4

Get the one Systolic Blood Pressure SDTM dataset specialization from the package released on October 26, 2022.

/mdr/specializations/sdtm/packages/2022-10-26/datasetspecializations/SYSBP

Code Block
languageyml
linenumberstrue
{
    "_links": {
        "parentBiomedicalConcept": {
            "href": "/mdr/bc/packages/2022-10-26/biomedicalconcepts/C25298",
            "title": "Systolic Blood Pressure",
            "type": "Biomedical Concept"
        },
        "parentPackage": {
            "href": "/mdr/specializations/sdtm/...datasetspecializations",
            "title": "SDTM Dataset Specialization Package Effective 2022-10-26",
            "type": "SDTM Dataset Specialization Package"
        },
        "self": {
            "href": "/mdr/specializations/sdtm/...datasetspecializations/SYSBP",
            "title": "Systolic Blood Pressure",
            "type": "SDTM Dataset Specialization"
        }
    },
Lines 2-18: A list of HATEOAS links to related resources, such as self, parent package, and parent biomedical concept. A note on parent biomedical concept: In this example, Systolic Blood Pressure is the parent biomedical concept to this SDTM dataset specialization.  parentBiomedicalConcept  will not be present if no parent is available at the time of publication.
Code Block
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firstline19
linenumberstrue
    "variables": [
        {
            "name": "VSORRESU",
            "dataElementConceptId": "C49669",
            "isNonStandard": false,
            "mandatoryValue": false,
            "mandatoryVariable": true,
            "role": "Qualifier",
            "relationship": {
                "linkingPhrase": "is the unit for the value in",
                "object": "VSORRES",
                "predicateTerm": "IS_UNIT_FOR",
                "subject": "VSORRESU"
            },
            "codelist": {
                "conceptId": "C66770",
                "href": "https://ncithesaurus.nci.nih.gov/...&code=C66770",
                "submissionValue": "VSRESU"
            },
            "assignedTerm": {
                "conceptId": "C49670",
                "value": "mmHG"
            },
            "vlmTarget": true
        },

Line 19: Beginning of a variable (or, data element) list that comprise this Systolic Blood Pressure SDTM dataset specialization.

Lines 20-43: VSORRESU (Line 21) is the first variable on the list. codelist (Lines 33-37) shows controlled terminology metadata for this variable. relationship (Lines 27-32) shows how this variable is related to another variable in the format of (subject, predicate, object): VSORRESU IS_UNIT_FOR VSORRES.

Code Block
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firstline44
linenumberstrue
        {
            "name": "VSSTRESN",
            "dataElementConceptId": "C173522",
            "isNonStandard": false,
            "dataType": "integer",
            "length": 3,
            "mandatoryValue": false,
            "mandatoryVariable": false,
            "role": "Qualifier",
            "relationship": {
                "linkingPhrase": "is the result of the test in",
                "object": "VSTESTCD",
                "predicateTerm": "IS_RESULT_OF",
                "subject": "VSSTRESN"
            },
            "vlmTarget": true
        },
        ...
    ],

Lines 44-60: VSSTRESN (Line 45) is the next variable on the list. It has an integer as datatype with a preconfigured length of 3. relationship (Lines 53-58) shows how this variable is related to another variable in the format of (subject, predicate, object): VSSTRESN IS_RESULT_OF VSTESTCD.

Code Block
languageyml
firstline63
linenumberstrue
    "datasetSpecializationId": "SYSBP",
    "domain": "VS",
    "sdtmigStartVersion": "3-2",
    "shortName": "Systolic Blood Pressure",
    "source": "VS.VSTESTCD"
}
Lines 63-67: Metadata about the SDTM dataset specialization.