How to properly represent data set specialization with a BC #206

pendingintent · 2026-04-28T15:43:33Z

pendingintent
Apr 28, 2026
Maintainer

The SOA Workbench allows the association of a single DataSet Specialization (DSS) with a Biomedical Concept (BC) assigned to a ScheduledActivityInstance.

There is support for creating the JSON representation of these BCs in the USDM file, but there is no way to include information regarding the DSS.

Although the implementation information is intended for inclusion in the USDM JSON file, this info would help downstream applications in processing the USDM JSON file. In future, including CRF Specialization info will help in the automation of CRF creation.

I have included sevceral proposals below.

Answered by lexjansen

Apr 30, 2026

Looks good!

A few small comments.
Maybe you misunderstood my intention, but I think we should not include base URL and version in the DSS valueString:

"extensionAttributes": [
    {
      "id": "ExtensionAttribute_1",
	  "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm",
	   "valueString": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/GLUCBLD"
    }

It should be:

"extensionAttributes": [
    {
      "id": "ExtensionAttribute_1",
	  "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm",
	   "valueString": "/mdr/specializations/sdtm/datasetspecializations/GLUCBLD"
    }

We can also add BiomedicalConcepts.DataEl…

View full answer

pendingintent · 2026-04-28T15:50:41Z

pendingintent
Apr 28, 2026
Maintainer Author

Once hte DSS has been associated with a BC in the SOA Workbench, we use extensionAttributes class to capture info that will aid with downstream applications.

I have used Systolic Blood Pressure as the DSS.

HREF: "/mdr/specializations/sdtm/datasetspecializations/SYSBP"

extensionAttributes: [

	{
		"id": "ExtensionAttribute_1",
		"url": "http://www.cdisc.org/datasetspecialization/href",
		"valueString": "/mdr/specializations/sdtm/datasetspecializations/SYSBP"
	},
	{
		"id": "ExtrensionAttribute_2",
		"url": "http://www.cdisc.org/datasetspecialization/datasetSpecializationId",
		"valueString": "SYSBP"
	},
	{
		"id": "ExtrensionAttribute_3",
		"url": "http://www.cdisc.org/datasetspecialization/domain",
		"valueString": "VS"
	},
	{
		"id": "ExtrensionAttribute_4",
		"url": "http://www.cdisc.org/datasetspecialization/source",
		"valueString": "VSTESTCD"
	}

]

This is the simplest approach, and the extensionAttributes.valueString where id = "ExtensionAttribute_1", includes the HREF required to send a request to the CDISC Library API. Teh developer can then parse the response from the API for all fields required.

If this is the only data required in the extensionAttributes is the HREF, teh programming becomes even easier.

extensionAttributes: [

	{
		"id": "ExtensionAttribute_1",
		"url": "http://www.cdisc.org/datasetspecialization/href",
		"valueString": "/mdr/specializations/sdtm/datasetspecializations/SYSBP"
	}
]

This is all that is required for a programmer to use the href value to request all data for the DSS from the CDISC Library API.

7 replies

pendingintent Apr 30, 2026
Maintainer Author

Reponses will not be included in the USDM. DEC will be mapped as BiomedicalConceptProperty but there is not enough information in the BC API response to populate all BiomedicalConceptProperty attributes. This is a limitation.

A single DSS is selected to be associated with a BC in the case where multiple DSS can be assigned. My thought was that a developer parsing the USDM will have enough detail to hit the API, parse the response and use the info to continue with their pipeline.

BSnoeijerCD Apr 30, 2026

ok. That is indeed a solution. Not sure whether this extension is needed then as the BC id can already be linked to the corresponding specialization(s) and the set of enabled properties can be use to select the best one of the corresponding specializations.

pendingintent Apr 30, 2026
Maintainer Author

True. I believe adding the extension is there to support downstream programming, i.e., CRF, Define-XML, SDTM. This is really a custom implementation to support the automation activities.

lexjansen Apr 30, 2026

Since multiple DSS can be associated with a BC, I think it makes sense to have that selection as part of the study design. The implementation is then further downstream.

pendingintent Apr 30, 2026
Maintainer Author

The Workbench currently supports associating a DSS with a BC, so the information is already in the database. I only need to add the extensionAttribute to the BC USDM JSON generator.

pendingintent · 2026-04-28T15:51:41Z

pendingintent
Apr 28, 2026
Maintainer Author

An alternative is to include all data in the response in the USDM JSON file.

{
  "id": "BC-SYSBP-001",
  "instanceType": "BiomedicalConcept",
  "name": "Systolic Blood Pressure",
  "label": "Systolic Blood Pressure",
  "reference": "https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C25298",
  "code": {
    "id": "AC-SYSBP-001",
    "instanceType": "AliasCode",
    "standardCode": {
      "id": "C-SYSBP-NCI-001",
      "instanceType": "Code",
      "code": "C25298",
      "codeSystem": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
      "codeSystemVersion": "24.04e",
      "decode": "Systolic Blood Pressure"
    }
  },

  "extensionAttributes": [

    {
      "id": "EXT-DS-ID",
      "instanceType": "ExtensionAttribute",
      "url": "https://sponsor.example.com/usdm/ext/datasetSpecialization/id",
      "valueString": "SYSBP"
    },
    {
      "id": "EXT-DS-DOMAIN",
      "instanceType": "ExtensionAttribute",
      "url": "https://sponsor.example.com/usdm/ext/datasetSpecialization/domain",
      "valueString": "VS"
    },
    {
      "id": "EXT-DS-SHORTNAME",
      "instanceType": "ExtensionAttribute",
      "url": "https://sponsor.example.com/usdm/ext/datasetSpecialization/shortName",
      "valueString": "Systolic Blood Pressure"
    },
    {
      "id": "EXT-DS-SOURCE",
      "instanceType": "ExtensionAttribute",
      "url": "https://sponsor.example.com/usdm/ext/datasetSpecialization/source",
      "valueString": "VS.VSTESTCD"
    },
    {
      "id": "EXT-DS-SDTMIG-START",
      "instanceType": "ExtensionAttribute",
      "url": "https://sponsor.example.com/usdm/ext/datasetSpecialization/sdtmigStartVersion",
      "valueString": "3-2"
    },
    {
      "id": "EXT-DS-SDTMIG-END",
      "instanceType": "ExtensionAttribute",
      "url": "https://sponsor.example.com/usdm/ext/datasetSpecialization/sdtmigEndVersion",
      "valueString": ""
    },
    {
      "id": "EXT-DS-HREF",
      "instanceType": "ExtensionAttribute",
      "url": "https://sponsor.example.com/usdm/ext/datasetSpecialization/href",
      "valueString": "/mdr/specializations/sdtm/datasetspecializations/SYSBP"
    },
    {
      "id": "EXT-DS-PKG-HREF",
      "instanceType": "ExtensionAttribute",
      "url": "https://sponsor.example.com/usdm/ext/datasetSpecialization/packageHref",
      "valueString": "/mdr/specializations/sdtm/packages/2025-04-01/datasetspecializations"
    },

    {
      "id": "EXT-VAR-VSTESTCD",
      "instanceType": "ExtensionAttribute",
      "url": "https://sponsor.example.com/usdm/ext/datasetSpecialization/variable",
      "valueExtensionClass": {
        "id": "EC-VAR-VSTESTCD",
        "instanceType": "ExtensionClass",
        "url": "https://sponsor.example.com/usdm/ext/datasetSpecialization/variable",
        "extensionAttributes": [
          { "id": "EXT-VAR-VSTESTCD-NAME",        "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/name",                    "valueString": "VSTESTCD" },
          { "id": "EXT-VAR-VSTESTCD-NONSTD",      "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/isNonStandard",            "valueBoolean": false },
          { "id": "EXT-VAR-VSTESTCD-ROLE",         "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/role",                    "valueString": "Topic" },
          { "id": "EXT-VAR-VSTESTCD-MANDATORY",   "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/mandatoryVariable",        "valueBoolean": true },
          { "id": "EXT-VAR-VSTESTCD-MANDVAL",     "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/mandatoryValue",           "valueBoolean": false },
          { "id": "EXT-VAR-VSTESTCD-COMPARATOR",  "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/comparator",               "valueString": "EQ" },
          { "id": "EXT-VAR-VSTESTCD-CL-ID",       "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/codelist/conceptId",       "valueString": "C66741" },
          { "id": "EXT-VAR-VSTESTCD-CL-SUBVAL",   "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/codelist/submissionValue", "valueString": "VSTESTCD" },
          { "id": "EXT-VAR-VSTESTCD-CL-HREF",     "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/codelist/href",            "valueString": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C66741" },
          { "id": "EXT-VAR-VSTESTCD-AT-ID",       "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/assignedTerm/conceptId",   "valueString": "C25298" },
          { "id": "EXT-VAR-VSTESTCD-AT-VAL",      "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/assignedTerm/value",       "valueString": "SYSBP" },
          { "id": "EXT-VAR-VSTESTCD-REL-SUBJ",    "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/subject",     "valueString": "VSTESTCD" },
          { "id": "EXT-VAR-VSTESTCD-REL-LINK",    "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/linkingPhrase","valueString": "is the code for the value in" },
          { "id": "EXT-VAR-VSTESTCD-REL-PRED",    "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/predicateTerm","valueString": "IS_DECODED_BY" },
          { "id": "EXT-VAR-VSTESTCD-REL-OBJ",     "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/object",      "valueString": "VSTEST" }
        ]
      }
    },

    {
      "id": "EXT-VAR-VSTEST",
      "instanceType": "ExtensionAttribute",
      "url": "https://sponsor.example.com/usdm/ext/datasetSpecialization/variable",
      "valueExtensionClass": {
        "id": "EC-VAR-VSTEST",
        "instanceType": "ExtensionClass",
        "url": "https://sponsor.example.com/usdm/ext/datasetSpecialization/variable",
        "extensionAttributes": [
          { "id": "EXT-VAR-VSTEST-NAME",       "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/name",                    "valueString": "VSTEST" },
          { "id": "EXT-VAR-VSTEST-NONSTD",     "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/isNonStandard",            "valueBoolean": false },
          { "id": "EXT-VAR-VSTEST-ROLE",        "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/role",                    "valueString": "Qualifier" },
          { "id": "EXT-VAR-VSTEST-MANDATORY",  "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/mandatoryVariable",        "valueBoolean": true },
          { "id": "EXT-VAR-VSTEST-MANDVAL",    "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/mandatoryValue",           "valueBoolean": false },
          { "id": "EXT-VAR-VSTEST-CL-ID",      "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/codelist/conceptId",       "valueString": "C67153" },
          { "id": "EXT-VAR-VSTEST-CL-SUBVAL",  "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/codelist/submissionValue", "valueString": "VSTEST" },
          { "id": "EXT-VAR-VSTEST-CL-HREF",    "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/codelist/href",            "valueString": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C67153" },
          { "id": "EXT-VAR-VSTEST-AT-ID",      "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/assignedTerm/conceptId",   "valueString": "C25298" },
          { "id": "EXT-VAR-VSTEST-AT-VAL",     "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/assignedTerm/value",       "valueString": "Systolic Blood Pressure" },
          { "id": "EXT-VAR-VSTEST-REL-SUBJ",   "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/subject",     "valueString": "VSTEST" },
          { "id": "EXT-VAR-VSTEST-REL-LINK",   "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/linkingPhrase","valueString": "decodes the value in" },
          { "id": "EXT-VAR-VSTEST-REL-PRED",   "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/predicateTerm","valueString": "DECODES" },
          { "id": "EXT-VAR-VSTEST-REL-OBJ",    "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/object",      "valueString": "VSTESTCD" }
        ]
      }
    },

    {
      "id": "EXT-VAR-VSORRES",
      "instanceType": "ExtensionAttribute",
      "url": "https://sponsor.example.com/usdm/ext/datasetSpecialization/variable",
      "valueExtensionClass": {
        "id": "EC-VAR-VSORRES",
        "instanceType": "ExtensionClass",
        "url": "https://sponsor.example.com/usdm/ext/datasetSpecialization/variable",
        "extensionAttributes": [
          { "id": "EXT-VAR-VSORRES-NAME",       "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/name",                    "valueString": "VSORRES" },
          { "id": "EXT-VAR-VSORRES-DECID",      "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/dataElementConceptId",    "valueString": "C70856" },
          { "id": "EXT-VAR-VSORRES-NONSTD",     "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/isNonStandard",            "valueBoolean": false },
          { "id": "EXT-VAR-VSORRES-ROLE",        "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/role",                    "valueString": "Qualifier" },
          { "id": "EXT-VAR-VSORRES-DTYPE",      "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/dataType",                "valueString": "integer" },
          { "id": "EXT-VAR-VSORRES-LEN",        "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/length",                  "valueInteger": 3 },
          { "id": "EXT-VAR-VSORRES-MANDATORY",  "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/mandatoryVariable",        "valueBoolean": true },
          { "id": "EXT-VAR-VSORRES-MANDVAL",    "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/mandatoryValue",           "valueBoolean": false },
          { "id": "EXT-VAR-VSORRES-ORIGTYPE",   "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/originType",               "valueString": "Collected" },
          { "id": "EXT-VAR-VSORRES-ORIGSRC",    "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/originSource",             "valueString": "Investigator" },
          { "id": "EXT-VAR-VSORRES-VLM",        "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/vlmTarget",               "valueBoolean": true },
          { "id": "EXT-VAR-VSORRES-REL-SUBJ",   "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/subject",     "valueString": "VSORRES" },
          { "id": "EXT-VAR-VSORRES-REL-LINK",   "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/linkingPhrase","valueString": "is the result of the test in" },
          { "id": "EXT-VAR-VSORRES-REL-PRED",   "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/predicateTerm","valueString": "IS_RESULT_OF" },
          { "id": "EXT-VAR-VSORRES-REL-OBJ",    "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/object",      "valueString": "VSTESTCD" }
        ]
      }
    },

    {
      "id": "EXT-VAR-VSORRESU",
      "instanceType": "ExtensionAttribute",
      "url": "https://sponsor.example.com/usdm/ext/datasetSpecialization/variable",
      "valueExtensionClass": {
        "id": "EC-VAR-VSORRESU",
        "instanceType": "ExtensionClass",
        "url": "https://sponsor.example.com/usdm/ext/datasetSpecialization/variable",
        "extensionAttributes": [
          { "id": "EXT-VAR-VSORRESU-NAME",      "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/name",                    "valueString": "VSORRESU" },
          { "id": "EXT-VAR-VSORRESU-DECID",     "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/dataElementConceptId",    "valueString": "C49669" },
          { "id": "EXT-VAR-VSORRESU-NONSTD",    "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/isNonStandard",            "valueBoolean": false },
          { "id": "EXT-VAR-VSORRESU-ROLE",       "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/role",                    "valueString": "Qualifier" },
          { "id": "EXT-VAR-VSORRESU-MANDATORY", "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/mandatoryVariable",        "valueBoolean": true },
          { "id": "EXT-VAR-VSORRESU-MANDVAL",   "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/mandatoryValue",           "valueBoolean": false },
          { "id": "EXT-VAR-VSORRESU-VLM",       "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/vlmTarget",               "valueBoolean": true },
          { "id": "EXT-VAR-VSORRESU-CL-ID",     "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/codelist/conceptId",       "valueString": "C66770" },
          { "id": "EXT-VAR-VSORRESU-CL-SUBVAL", "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/codelist/submissionValue", "valueString": "VSRESU" },
          { "id": "EXT-VAR-VSORRESU-CL-HREF",   "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/codelist/href",            "valueString": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C66770" },
          { "id": "EXT-VAR-VSORRESU-AT-ID",     "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/assignedTerm/conceptId",   "valueString": "C49670" },
          { "id": "EXT-VAR-VSORRESU-AT-VAL",    "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/assignedTerm/value",       "valueString": "mmHg" },
          { "id": "EXT-VAR-VSORRESU-REL-SUBJ",  "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/subject",     "valueString": "VSORRESU" },
          { "id": "EXT-VAR-VSORRESU-REL-LINK",  "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/linkingPhrase","valueString": "is the unit for the value in" },
          { "id": "EXT-VAR-VSORRESU-REL-PRED",  "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/predicateTerm","valueString": "IS_UNIT_FOR" },
          { "id": "EXT-VAR-VSORRESU-REL-OBJ",   "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/object",      "valueString": "VSORRES" }
        ]
      }
    },

    {
      "id": "EXT-VAR-VSSTRESC",
      "instanceType": "ExtensionAttribute",
      "url": "https://sponsor.example.com/usdm/ext/datasetSpecialization/variable",
      "valueExtensionClass": {
        "id": "EC-VAR-VSSTRESC",
        "instanceType": "ExtensionClass",
        "url": "https://sponsor.example.com/usdm/ext/datasetSpecialization/variable",
        "extensionAttributes": [
          { "id": "EXT-VAR-VSSTRESC-NAME",      "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/name",                    "valueString": "VSSTRESC" },
          { "id": "EXT-VAR-VSSTRESC-DECID",     "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/dataElementConceptId",    "valueString": "C70856" },
          { "id": "EXT-VAR-VSSTRESC-NONSTD",    "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/isNonStandard",            "valueBoolean": false },
          { "id": "EXT-VAR-VSSTRESC-ROLE",       "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/role",                    "valueString": "Qualifier" },
          { "id": "EXT-VAR-VSSTRESC-DTYPE",     "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/dataType",                "valueString": "integer" },
          { "id": "EXT-VAR-VSSTRESC-LEN",       "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/length",                  "valueInteger": 3 },
          { "id": "EXT-VAR-VSSTRESC-MANDATORY", "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/mandatoryVariable",        "valueBoolean": false },
          { "id": "EXT-VAR-VSSTRESC-MANDVAL",   "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/mandatoryValue",           "valueBoolean": false },
          { "id": "EXT-VAR-VSSTRESC-VLM",       "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/vlmTarget",               "valueBoolean": true },
          { "id": "EXT-VAR-VSSTRESC-REL-SUBJ",  "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/subject",     "valueString": "VSSTRESC" },
          { "id": "EXT-VAR-VSSTRESC-REL-LINK",  "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/linkingPhrase","valueString": "is the result of the test in" },
          { "id": "EXT-VAR-VSSTRESC-REL-PRED",  "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/predicateTerm","valueString": "IS_RESULT_OF" },
          { "id": "EXT-VAR-VSSTRESC-REL-OBJ",   "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/object",      "valueString": "VSTESTCD" }
        ]
      }
    },

    {
      "id": "EXT-VAR-VSSTRESN",
      "instanceType": "ExtensionAttribute",
      "url": "https://sponsor.example.com/usdm/ext/datasetSpecialization/variable",
      "valueExtensionClass": {
        "id": "EC-VAR-VSSTRESN",
        "instanceType": "ExtensionClass",
        "url": "https://sponsor.example.com/usdm/ext/datasetSpecialization/variable",
        "extensionAttributes": [
          { "id": "EXT-VAR-VSSTRESN-NAME",      "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/name",                    "valueString": "VSSTRESN" },
          { "id": "EXT-VAR-VSSTRESN-DECID",     "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/dataElementConceptId",    "valueString": "C70856" },
          { "id": "EXT-VAR-VSSTRESN-NONSTD",    "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/isNonStandard",            "valueBoolean": false },
          { "id": "EXT-VAR-VSSTRESN-ROLE",       "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/role",                    "valueString": "Qualifier" },
          { "id": "EXT-VAR-VSSTRESN-DTYPE",     "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/dataType",                "valueString": "integer" },
          { "id": "EXT-VAR-VSSTRESN-LEN",       "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/length",                  "valueInteger": 3 },
          { "id": "EXT-VAR-VSSTRESN-MANDATORY", "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/mandatoryVariable",        "valueBoolean": false },
          { "id": "EXT-VAR-VSSTRESN-MANDVAL",   "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/mandatoryValue",           "valueBoolean": false },
          { "id": "EXT-VAR-VSSTRESN-VLM",       "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/vlmTarget",               "valueBoolean": true },
          { "id": "EXT-VAR-VSSTRESN-REL-SUBJ",  "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/subject",     "valueString": "VSSTRESN" },
          { "id": "EXT-VAR-VSSTRESN-REL-LINK",  "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/linkingPhrase","valueString": "is the result of the test in" },
          { "id": "EXT-VAR-VSSTRESN-REL-PRED",  "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/predicateTerm","valueString": "IS_RESULT_OF" },
          { "id": "EXT-VAR-VSSTRESN-REL-OBJ",   "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/object",      "valueString": "VSTESTCD" }
        ]
      }
    },

    {
      "id": "EXT-VAR-VSSTRESU",
      "instanceType": "ExtensionAttribute",
      "url": "https://sponsor.example.com/usdm/ext/datasetSpecialization/variable",
      "valueExtensionClass": {
        "id": "EC-VAR-VSSTRESU",
        "instanceType": "ExtensionClass",
        "url": "https://sponsor.example.com/usdm/ext/datasetSpecialization/variable",
        "extensionAttributes": [
          { "id": "EXT-VAR-VSSTRESU-NAME",      "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/name",                    "valueString": "VSSTRESU" },
          { "id": "EXT-VAR-VSSTRESU-DECID",     "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/dataElementConceptId",    "valueString": "C49669" },
          { "id": "EXT-VAR-VSSTRESU-NONSTD",    "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/isNonStandard",            "valueBoolean": false },
          { "id": "EXT-VAR-VSSTRESU-ROLE",       "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/role",                    "valueString": "Qualifier" },
          { "id": "EXT-VAR-VSSTRESU-MANDATORY", "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/mandatoryVariable",        "valueBoolean": false },
          { "id": "EXT-VAR-VSSTRESU-MANDVAL",   "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/mandatoryValue",           "valueBoolean": false },
          { "id": "EXT-VAR-VSSTRESU-VLM",       "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/vlmTarget",               "valueBoolean": true },
          { "id": "EXT-VAR-VSSTRESU-CL-ID",     "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/codelist/conceptId",       "valueString": "C66770" },
          { "id": "EXT-VAR-VSSTRESU-CL-SUBVAL", "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/codelist/submissionValue", "valueString": "VSRESU" },
          { "id": "EXT-VAR-VSSTRESU-CL-HREF",   "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/codelist/href",            "valueString": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C66770" },
          { "id": "EXT-VAR-VSSTRESU-AT-ID",     "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/assignedTerm/conceptId",   "valueString": "C49670" },
          { "id": "EXT-VAR-VSSTRESU-AT-VAL",    "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/assignedTerm/value",       "valueString": "mmHg" },
          { "id": "EXT-VAR-VSSTRESU-REL-SUBJ",  "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/subject",     "valueString": "VSSTRESU" },
          { "id": "EXT-VAR-VSSTRESU-REL-LINK",  "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/linkingPhrase","valueString": "is the unit for the value in" },
          { "id": "EXT-VAR-VSSTRESU-REL-PRED",  "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/predicateTerm","valueString": "IS_UNIT_FOR" },
          { "id": "EXT-VAR-VSSTRESU-REL-OBJ",   "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/object",      "valueString": "VSSTRESN" }
        ]
      }
    },

    {
      "id": "EXT-VAR-VSPOS",
      "instanceType": "ExtensionAttribute",
      "url": "https://sponsor.example.com/usdm/ext/datasetSpecialization/variable",
      "valueExtensionClass": {
        "id": "EC-VAR-VSPOS",
        "instanceType": "ExtensionClass",
        "url": "https://sponsor.example.com/usdm/ext/datasetSpecialization/variable",
        "extensionAttributes": [
          { "id": "EXT-VAR-VSPOS-NAME",        "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/name",                    "valueString": "VSPOS" },
          { "id": "EXT-VAR-VSPOS-DECID",       "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/dataElementConceptId",    "valueString": "C62164" },
          { "id": "EXT-VAR-VSPOS-NONSTD",      "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/isNonStandard",            "valueBoolean": false },
          { "id": "EXT-VAR-VSPOS-ROLE",         "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/role",                    "valueString": "Qualifier" },
          { "id": "EXT-VAR-VSPOS-MANDATORY",   "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/mandatoryVariable",        "valueBoolean": false },
          { "id": "EXT-VAR-VSPOS-MANDVAL",     "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/mandatoryValue",           "valueBoolean": false },
          { "id": "EXT-VAR-VSPOS-COMPARATOR",  "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/comparator",               "valueString": "IN" },
          { "id": "EXT-VAR-VSPOS-CL-ID",       "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/codelist/conceptId",       "valueString": "C71148" },
          { "id": "EXT-VAR-VSPOS-CL-SUBVAL",   "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/codelist/submissionValue", "valueString": "POSITION" },
          { "id": "EXT-VAR-VSPOS-CL-HREF",     "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/codelist/href",            "valueString": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C71148" },
          { "id": "EXT-VAR-VSPOS-VL-1",        "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/valueList/item",           "valueString": "PRONE" },
          { "id": "EXT-VAR-VSPOS-VL-2",        "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/valueList/item",           "valueString": "SEMI-RECUMBENT" },
          { "id": "EXT-VAR-VSPOS-VL-3",        "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/valueList/item",           "valueString": "SITTING" },
          { "id": "EXT-VAR-VSPOS-VL-4",        "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/valueList/item",           "valueString": "STANDING" },
          { "id": "EXT-VAR-VSPOS-VL-5",        "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/valueList/item",           "valueString": "SUPINE" },
          { "id": "EXT-VAR-VSPOS-REL-SUBJ",    "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/subject",     "valueString": "VSPOS" },
          { "id": "EXT-VAR-VSPOS-REL-LINK",    "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/linkingPhrase","valueString": "is the subject position during performance of the test in" },
          { "id": "EXT-VAR-VSPOS-REL-PRED",    "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/predicateTerm","valueString": "IS_SUBJECT_STATE_FOR" },
          { "id": "EXT-VAR-VSPOS-REL-OBJ",     "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/object",      "valueString": "VSTESTCD" }
        ]
      }
    },

    {
      "id": "EXT-VAR-VSLOC",
      "instanceType": "ExtensionAttribute",
      "url": "https://sponsor.example.com/usdm/ext/datasetSpecialization/variable",
      "valueExtensionClass": {
        "id": "EC-VAR-VSLOC",
        "instanceType": "ExtensionClass",
        "url": "https://sponsor.example.com/usdm/ext/datasetSpecialization/variable",
        "extensionAttributes": [
          { "id": "EXT-VAR-VSLOC-NAME",        "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/name",                    "valueString": "VSLOC" },
          { "id": "EXT-VAR-VSLOC-DECID",       "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/dataElementConceptId",    "valueString": "C13717" },
          { "id": "EXT-VAR-VSLOC-NONSTD",      "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/isNonStandard",            "valueBoolean": false },
          { "id": "EXT-VAR-VSLOC-ROLE",         "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/role",                    "valueString": "Qualifier" },
          { "id": "EXT-VAR-VSLOC-MANDATORY",   "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/mandatoryVariable",        "valueBoolean": false },
          { "id": "EXT-VAR-VSLOC-MANDVAL",     "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/mandatoryValue",           "valueBoolean": false },
          { "id": "EXT-VAR-VSLOC-COMPARATOR",  "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/comparator",               "valueString": "IN" },
          { "id": "EXT-VAR-VSLOC-CL-ID",       "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/codelist/conceptId",       "valueString": "C74456" },
          { "id": "EXT-VAR-VSLOC-CL-SUBVAL",   "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/codelist/submissionValue", "valueString": "LOC" },
          { "id": "EXT-VAR-VSLOC-CL-HREF",     "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/codelist/href",            "valueString": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C74456" },
          { "id": "EXT-VAR-VSLOC-VL-1",        "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/valueList/item",           "valueString": "BRACHIAL ARTERY" },
          { "id": "EXT-VAR-VSLOC-VL-2",        "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/valueList/item",           "valueString": "CAROTID ARTERY" },
          { "id": "EXT-VAR-VSLOC-VL-3",        "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/valueList/item",           "valueString": "DORSALIS PEDIS ARTERY" },
          { "id": "EXT-VAR-VSLOC-VL-4",        "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/valueList/item",           "valueString": "FEMORAL ARTERY" },
          { "id": "EXT-VAR-VSLOC-VL-5",        "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/valueList/item",           "valueString": "FINGER" },
          { "id": "EXT-VAR-VSLOC-VL-6",        "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/valueList/item",           "valueString": "PERIPHERAL ARTERY" },
          { "id": "EXT-VAR-VSLOC-VL-7",        "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/valueList/item",           "valueString": "RADIAL ARTERY" },
          { "id": "EXT-VAR-VSLOC-REL-SUBJ",    "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/subject",     "valueString": "VSLOC" },
          { "id": "EXT-VAR-VSLOC-REL-LINK",    "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/linkingPhrase","valueString": "specifies the anatomical location of the performance of the test in" },
          { "id": "EXT-VAR-VSLOC-REL-PRED",    "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/predicateTerm","valueString": "SPECIFIES" },
          { "id": "EXT-VAR-VSLOC-REL-OBJ",     "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/object",      "valueString": "VSTESTCD" }
        ]
      }
    },

    {
      "id": "EXT-VAR-VSLAT",
      "instanceType": "ExtensionAttribute",
      "url": "https://sponsor.example.com/usdm/ext/datasetSpecialization/variable",
      "valueExtensionClass": {
        "id": "EC-VAR-VSLAT",
        "instanceType": "ExtensionClass",
        "url": "https://sponsor.example.com/usdm/ext/datasetSpecialization/variable",
        "extensionAttributes": [
          { "id": "EXT-VAR-VSLAT-NAME",        "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/name",                    "valueString": "VSLAT" },
          { "id": "EXT-VAR-VSLAT-DECID",       "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/dataElementConceptId",    "valueString": "C25185" },
          { "id": "EXT-VAR-VSLAT-NONSTD",      "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/isNonStandard",            "valueBoolean": false },
          { "id": "EXT-VAR-VSLAT-ROLE",         "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/role",                    "valueString": "Qualifier" },
          { "id": "EXT-VAR-VSLAT-MANDATORY",   "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/mandatoryVariable",        "valueBoolean": false },
          { "id": "EXT-VAR-VSLAT-MANDVAL",     "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/mandatoryValue",           "valueBoolean": false },
          { "id": "EXT-VAR-VSLAT-COMPARATOR",  "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/comparator",               "valueString": "IN" },
          { "id": "EXT-VAR-VSLAT-CL-ID",       "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/codelist/conceptId",       "valueString": "C99073" },
          { "id": "EXT-VAR-VSLAT-CL-SUBVAL",   "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/codelist/submissionValue", "valueString": "LAT" },
          { "id": "EXT-VAR-VSLAT-CL-HREF",     "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/codelist/href",            "valueString": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C99073" },
          { "id": "EXT-VAR-VSLAT-SUBSET-CL",   "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/subsetCodelist",           "valueString": "VSLAT_BP" },
          { "id": "EXT-VAR-VSLAT-VL-1",        "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/valueList/item",           "valueString": "LEFT" },
          { "id": "EXT-VAR-VSLAT-VL-2",        "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/valueList/item",           "valueString": "RIGHT" },
          { "id": "EXT-VAR-VSLAT-REL-SUBJ",    "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/subject",     "valueString": "VSLAT" },
          { "id": "EXT-VAR-VSLAT-REL-LINK",    "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/linkingPhrase","valueString": "further specifies the anatomical location in" },
          { "id": "EXT-VAR-VSLAT-REL-PRED",    "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/predicateTerm","valueString": "SPECIFIES" },
          { "id": "EXT-VAR-VSLAT-REL-OBJ",     "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/object",      "valueString": "VSLOC" }
        ]
      }
    },

    {
      "id": "EXT-VAR-VSDTC",
      "instanceType": "ExtensionAttribute",
      "url": "https://sponsor.example.com/usdm/ext/datasetSpecialization/variable",
      "valueExtensionClass": {
        "id": "EC-VAR-VSDTC",
        "instanceType": "ExtensionClass",
        "url": "https://sponsor.example.com/usdm/ext/datasetSpecialization/variable",
        "extensionAttributes": [
          { "id": "EXT-VAR-VSDTC-NAME",       "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/name",                    "valueString": "VSDTC" },
          { "id": "EXT-VAR-VSDTC-DECID",      "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/dataElementConceptId",    "valueString": "C82515" },
          { "id": "EXT-VAR-VSDTC-NONSTD",     "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/isNonStandard",            "valueBoolean": false },
          { "id": "EXT-VAR-VSDTC-ROLE",        "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/role",                    "valueString": "Timing" },
          { "id": "EXT-VAR-VSDTC-MANDATORY",  "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/mandatoryVariable",        "valueBoolean": true },
          { "id": "EXT-VAR-VSDTC-MANDVAL",    "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/mandatoryValue",           "valueBoolean": false },
          { "id": "EXT-VAR-VSDTC-REL-SUBJ",   "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/subject",     "valueString": "VSDTC" },
          { "id": "EXT-VAR-VSDTC-REL-LINK",   "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/linkingPhrase","valueString": "is the date of occurrence for" },
          { "id": "EXT-VAR-VSDTC-REL-PRED",   "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/predicateTerm","valueString": "IS_TIMING_FOR" },
          { "id": "EXT-VAR-VSDTC-REL-OBJ",    "instanceType": "ExtensionAttribute", "url": "https://sponsor.example.com/usdm/ext/variable/relationship/object",      "valueString": "VSTESTCD" }
        ]
      }
    }

  ],

  "properties": []
}

5 replies

pendingintent Apr 28, 2026
Maintainer Author

This will have a dramatic effect on the USDM JSON file size. In programmatic terms, only including the DSS HREF in the USDM JSON will give a developer parsing the USDM all of the information she needs to request the DSS data from the CDISC Library and keeps all of the implementation detail out of the USDM JSON.

BSnoeijerCD Apr 30, 2026

Not sure if I completely understand and whether this is of added value. I would link/refer to DSS not include it completely in USDM.

pendingintent Apr 30, 2026
Maintainer Author

I only included this as the extreme example. I will not be adding the above to the USDM.

For simplicity, I plan to stick to:

extensionAttributes: [

	{
		"id": "ExtensionAttribute_1",
		"url": "http://www.cdisc.org/datasetspecialization/href",
		"valueString": "/mdr/specializations/sdtm/datasetspecializations/SYSBP"
	}
]

lexjansen Apr 30, 2026

Probably good to make clear that it is is a USDM extension, specifically the SDTM dataset specialization:
The value string is more an endpoint than an href, since we don't include base url or API version.
So, maybe:
"url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm"
or
"url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm/endpoint"

pendingintent Apr 30, 2026
Maintainer Author

Agreed

lexjansen · 2026-04-29T15:25:11Z

lexjansen
Apr 29, 2026

When designing a study the study designer selects the Biomedical Concepts (BC) that are associated with an activity. For downstream applications that implement the study it is useful to know which specialization(s) are selected with a particular BC. This can be SDTM dataset specializations, CRF specializations, etc. It is not the intention of the USDM to capture full implementation details of these specializations. The unique identifier of the specialization would be enough. Having this unique identifier would allow the downstream application to extract full details of the specialization.
It makes no sense to me at all to add all specialization metadata in the response in the USDM JSON file. This just adds an unnecessary layer and complexity.

I think the following should be enough:

extensionAttributes: [

	{
		"id": "ExtensionAttribute_1",
		"url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm",
		"valueString": "/mdr/specializations/sdtm/datasetspecializations/SYSBP"
	}
]

and later:

extensionAttributes: [

	{
		"id": "ExtensionAttribute_2",
		"url": "http://www.cdisc.org/usdm/extensions/specializations/crf",
		"valueString": "/mdr/specializations/crf/specializations/SYSBP_DENORMALIZED"
	}
]

I believe this is all the information we need for representing the specializations in the USDM JSON file.

Btw, as far as the reference property for the BC, I think I it should be:
"reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C25298"
instead of:
"reference": "https://ncithesaurus.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C25298"

5 replies

pendingintent Apr 29, 2026
Maintainer Author

reference will be https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C25298 when generated from the workbench. The JSON content above is a mock-up. I can share the JSON for the BCs once I have implemented this enhancement.

BSnoeijerCD Apr 30, 2026

As indicated above @lexjansen: You then miss the link with the selected properties and value sets in the design if you only refer to the specializations. USDM can be seen as the definition tooling that guides the automatic selection of the BCs/Specializations. So for example, if some denormalized properties are selected in the USDM then automatically it can link to the denormalized type instead of the standard one. Or it can guide the addition of attributes to the standard example specializations based on the selected properties or additionally defined properties.

I am trying to map the completely picture for a number of domains, but the SDTM specializations and eCRF specializations are much more likely to be seen as examples/subsets instead of the full picture. There are a lot of issues and exceptions if you try it in real practice. Also we are far from complete now.

lexjansen Apr 30, 2026

It is fully recognized that SDTM and eCRF specializations are not normative, but will have to be configured for implementation.
I do think that the DECs should be part of the USDM JSON file as BC properties. The responses that the DECs have in the CDISC BC model, are just example values. The SDTM spec has a response when applicable (value list).

BSnoeijerCD Apr 30, 2026

BC2USDM_Map.docx
I think I already shared this somewhere. But see the mapping from BC to USDM in this file.

pendingintent May 1, 2026
Maintainer Author

Thank you, @BSnoeijerCD. I have reviewed your document and will raise some enhancements to include the functionality as you describe. The following features will be introduced at a later date.

o For each selected data element concept/property indicate whether it is enabled and/or required
o Select subset of example set and store as related response codes and indicate for each one whether enabled

For categories, I have yet to leverage categories in the Workbench, but the behavior you decsribe is in my Backlog.

I will be sharing out a new BC JSON snippet once I have implemented the logic.

pendingintent · 2026-04-30T14:31:54Z

pendingintent
Apr 30, 2026
Maintainer Author

There is an alternative to including any operational info in the USDM. The Workbench can be used by the end-user to map a DSS (or a CRF specialization in the future) to a BC and the info is stored in the database. I can extend the Workbench to produce a mapping spec/doc rather than including the DSS reference in the USDM as an extensionAttribute.

0 replies

pendingintent · 2026-04-30T16:02:01Z

pendingintent
Apr 30, 2026
Maintainer Author

Here is the proposed appearance of the Glucose Measurement biomedical concept in the USDM JSON file.

I have added the proposed extensionAttributes for the ASSIGNED SDTM dataset specialization. Please note that the user must choose from the list of available dataset specializations available to the BC Glucose Measurement.

i.e.:

https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/datasetspecializations?biomedicalconcept=C105585

{
    "_links": {
        "datasetSpecializations": {
            "sdtm": [
                {
                    "href": "/mdr/specializations/sdtm/datasetspecializations/GLUCBLD",
                    "title": "Glucose Concentration in Blood",
                    "type": "SDTM Dataset Specialization"
                },
                {
                    "href": "/mdr/specializations/sdtm/datasetspecializations/GLUCPL",
                    "title": "Glucose Concentration in Plasma",
                    "type": "SDTM Dataset Specialization"
                },
                {
                    "href": "/mdr/specializations/sdtm/datasetspecializations/GLUCSER",
                    "title": "Glucose Concentration in Serum",
                    "type": "SDTM Dataset Specialization"
                },
                {
                    "href": "/mdr/specializations/sdtm/datasetspecializations/GLUCURIN",
                    "title": "Glucose Concentration in Urine",
                    "type": "SDTM Dataset Specialization"
                },
                {
                    "href": "/mdr/specializations/sdtm/datasetspecializations/GLUCUA",
                    "title": "Glucose Presence in Urine by Test Strip",
                    "type": "SDTM Dataset Specialization"
                },
                {
                    "href": "/mdr/specializations/sdtm/datasetspecializations/GLUCURINPRES",
                    "title": "Glucose Presence in Urine",
                    "type": "SDTM Dataset Specialization"
                },
                {
                    "href": "/mdr/specializations/sdtm/datasetspecializations/GLUCPE",
                    "title": "Plasma Equivalent Glucose",
                    "type": "SDTM Dataset Specialization"
                },
                {
                    "href": "/mdr/specializations/sdtm/datasetspecializations/GLUCSERPL",
                    "title": "Glucose Concentration in Serum or Plasma",
                    "type": "SDTM Dataset Specialization"
                }
            ]
        },
        "self": {
            "href": "/mdr/specializations/datasetspecializations?biomedicalconcept=C105585",
            "title": "Dataset Specializations that specialize a Biomedical Concept",
            "type": "Dataset Specializations List"
        },
        "parentBiomedicalConcept": {
            "href": "/mdr/bc/biomedicalconcepts/C105585",
            "title": "Glucose Measurement",
            "type": "Biomedical Concept"
        }
    },
    "name": "Dataset Specializations (latest version)",
    "label": "Dataset Specializations List"
}

As it would appear in the USDM JSON file:

{
  "id": "BiomedicalConcept_89",
  "extensionAttributes": [
    {
      "id": "ExtensionAttribute_1",
      "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm",
      "valueString": "/mdr/specializations/sdtm/datasetspecializations/GLUCBLD"
    }
  ],
  "name": "Glucose Measurement",
  "label": "Glucose Measurement",
  "synonyms": [
    "Glucose"
  ],
  "reference": "https://evsexplore.semantics.cancer.gov/evsexplore/concept/ncit/C105585",
  "properties": [
    {
      "id": "BiomedicalConceptProperty_1",
      "extensionAttributes": [],
      "name": "Observation Result",
      "label": "Observation Result",
      "isRequired": true,
      "isEnabled": true,
      "datatype": "string",
      "responseCodes": [],
      "code": {
        "id": "AliasCode_2",
        "standardCode": {
          "id": "Code_1",
          "extensionAttributes": [],
          "code": "C70856",
          "codeSystem": "https://evsexplore.semantics.cancer.gov",
          "codeSystemVersion": "1",
          "decode": "Observation Result",
          "instanceType": "Code"
        },
        "instanceType": "AliasCode"
      },
      "notes": [],
      "instanceType": "BiomedicalConceptProperty"
    },
    {
      "id": "BiomedicalConceptProperty_2",
      "extensionAttributes": [],
      "name": "Biospecimen Type",
      "label": "Biospecimen Type",
      "isRequired": true,
      "isEnabled": true,
      "datatype": "string",
      "responseCodes": [],
      "code": {
        "id": "AliasCode_3",
        "standardCode": {
          "id": "Code_2",
          "extensionAttributes": [],
          "code": "C70713",
          "codeSystem": "https://evsexplore.semantics.cancer.gov",
          "codeSystemVersion": "1",
          "decode": "Biospecimen Type",
          "instanceType": "Code"
        },
        "instanceType": "AliasCode"
      },
      "notes": [],
      "instanceType": "BiomedicalConceptProperty"
    },
    {
      "id": "BiomedicalConceptProperty_3",
      "extensionAttributes": [],
      "name": "Medical Device Identifier",
      "label": "Medical Device Identifier",
      "isRequired": true,
      "isEnabled": true,
      "datatype": "string",
      "responseCodes": [],
      "code": {
        "id": "AliasCode_4",
        "standardCode": {
          "id": "Code_3",
          "extensionAttributes": [],
          "code": "C215501",
          "codeSystem": "https://evsexplore.semantics.cancer.gov",
          "codeSystemVersion": "1",
          "decode": "Medical Device Identifier",
          "instanceType": "Code"
        },
        "instanceType": "AliasCode"
      },
      "notes": [],
      "instanceType": "BiomedicalConceptProperty"
    },
    {
      "id": "BiomedicalConceptProperty_4",
      "extensionAttributes": [],
      "name": "Collection Date Time",
      "label": "Collection Date Time",
      "isRequired": true,
      "isEnabled": true,
      "datatype": "datetime",
      "responseCodes": [],
      "code": {
        "id": "AliasCode_5",
        "standsardCode": {
          "id": "Code_4",
          "extensionAttributes": [],
          "code": "C82515",
          "codeSystem": "https://evsexplore.semantics.cancer.gov",
          "codeSystemVersion": "1",
          "decode": "Collection Date Time",
          "instanceType": "Code"
        },
        "instanceType": "AliasCode"
      },
      "notes": [],
      "instanceType": "BiomedicalConceptProperty"
    },
    {
      "id": "BiomedicalConceptProperty_5",
      "extensionAttributes": [],
      "name": "Unit of Concentration",
      "label": "Unit of Concentration",
      "isRequired": true,
      "isEnabled": true,
      "datatype": "string",
      "responseCodes": [],
      "code": {
        "id": "AliasCode_6",
        "standaraCode": {
          "id": "Code_5",
          "extensionAttributes": [],
          "code": "C48207",
          "codeSystem": "https://evsexplore.semantics.cancer.gov",
          "codeSystemVersion": "1",
          "decode": "Unit of Concentration",
          "instanceType": "Code"
        },
        "instanceType": "AliasCode"
      },
      "notes": [],
      "instanceType": "BiomedicalConceptProperty"
    },
    {
      "id": "BiomedicalConceptProperty_6",
      "extensionAttributes": [],
      "name": "Fasting Status Indicator",
      "label": "Fasting Status Indicator",
      "isRequired": true,
      "isEnabled": true,
      "datatype": "boolean",
      "responseCodes": [],
      "code": {
        "id": "AliasCode_7",
        "standardCode": {
          "id": "Code_6",
          "extensionAttributes": [],
          "code": "C93566",
          "codeSystem": "https://evsexplore.semantics.cancer.gov",
          "codeSystemVersion": "1",
          "decode": "Fasting Status Indicator",
          "instanceType": "Code"
        },
        "instanceType": "AliasCode"
      },
      "notes": [],
      "instanceType": "BiomedicalConceptProperty"
    },
    {
      "id": "BiomedicalConceptProperty_7",
      "extensionAttributes": [],
      "name": "Test Method",
      "label": "Test Method",
      "isRequired": true,
      "isEnabled": true,
      "datatype": "string",
      "responseCodes": [],
      "code": {
        "id": "AliasCode_8",
        "standardCode": {
          "id": "Code_7",
          "extensionAttributes": [],
          "code": "C82535",
          "codeSystem": "https://evsexplore.semantics.cancer.gov",
          "codeSystemVersion": "1",
          "decode": "Test Method",
          "instanceType": "Code"
        },
        "instanceType": "AliasCode"
      },
      "notes": [],
      "instanceType": "BiomedicalConceptProperty"
    }
  ],
  "code": {
    "id": "AliasCode_1222",
    "extensionAttributes": [],
    "standardCode": {
      "id": "Code_1412",
      "extensionAttributes": [],
      "code": "C105585",
      "codeSystem": "http://www.cdisc.org",
      "codeSystemVersion": "2025-09-23",
      "decode": "Glucose Measurement",
      "instanceType": "Code"
    },
    "standardCodeAliases": [],
    "instanceType": "AliasCode"
  },
  "notes": [],
  "instanceType": "BiomedicalConcept"
}

1 reply

pendingintent Apr 30, 2026
Maintainer Author

There is currently no information in the API response for a BC to help populate the BiomedicalConceptProperty attributes isRequired, isEnabled, codeSystemVersion.

lexjansen · 2026-04-30T19:22:40Z

lexjansen
Apr 30, 2026

Looks good!

A few small comments.
Maybe you misunderstood my intention, but I think we should not include base URL and version in the DSS valueString:

"extensionAttributes": [
    {
      "id": "ExtensionAttribute_1",
	  "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm",
	   "valueString": "https://api.library.cdisc.org/api/cosmos/v2/mdr/specializations/sdtm/datasetspecializations/GLUCBLD"
    }

It should be:

"extensionAttributes": [
    {
      "id": "ExtensionAttribute_1",
	  "url": "http://www.cdisc.org/usdm/extensions/specializations/sdtm",
	   "valueString": "/mdr/specializations/sdtm/datasetspecializations/GLUCBLD"
    }

We can also add BiomedicalConcepts.DataElementConcepts.Datatype as BiomedicalConcept.BiomedicalConceptProperty.datatype

We could add BiomedicalConcepts.DataElementConcepts.ExampleSet values as BiomedicalConcept.BiomedicalConceptProperty.responseCodes.label (without code).

2 replies

pendingintent Apr 30, 2026
Maintainer Author

Thank you @lexjansen. I have made the requested updates to the JSON above.

For the ReponseCode, Code is required so I would need to update the application to make multiple calls to the NCIt API to retrieve matching string values for any values included in the BC exampleSet attribute. I am going to omit the ReponseCodes for now. This can be dealt with in later versions.

lexjansen Apr 30, 2026

Oh, sorry, I thought the C-code was not required. I should have checked the model. Then we should not add the responses indeed.

pendingintent · 2026-05-01T12:01:09Z

pendingintent
May 1, 2026
Maintainer Author

Here is the BC snippet including BiomedicalConceptProperty values coming from the latest changes in the Workbench. I have yet to add the extensionAttributes.

pilot_biomedical_concepts.json

0 replies

pendingintent · 2026-05-01T12:55:53Z

pendingintent
May 1, 2026
Maintainer Author

I have added extensionAtributes population in the USDM JSON. EACH of the SDTM data set specializations assigned to a Biomedical Concept will have a unique ExtensionAttribute output in the USDM JSON. Attached is an example. The Medical History BC is an example of a BC with multiple DSS values assigned.

pilot_biomedical_concepts.json

1 reply

lexjansen May 1, 2026

When you say “each of the SDTM data set specializations assigned …”, I assume you mean the ones selected by the study designer, which may not be all of the specializations that come back from the API (give me all the specializations that specialize a specific BC).

pendingintent · 2026-05-11T07:12:22Z

pendingintent
May 11, 2026
Maintainer Author

The SOA Workbench allows the association of a single DataSet Specialization (DSS) with a Biomedical Concept (BC) assigned to a ScheduledActivityInstance.

There is support for creating the JSON representation of these BCs in the USDM file, but there is no way to include information regarding the DSS.

Although the implementation information is intended for inclusion in the USDM JSON file, this info would help downstream applications in processing the USDM JSON file. In future, including CRF Specialization info will help in the automation of CRF creation.

I have included sevceral proposals below.

Mulitiple DSS can be associated with a BC. The original text is incorrect.

0 replies

pendingintent · 2026-05-22T08:31:27Z

pendingintent
May 22, 2026
Maintainer Author

I am not including DSS in the USDM JSON, since it is not required. The Workbench allows for the mapping of a DSS to a BiomedicalConcept and the data in the database can be extracted to support SDTM dataset creation.

I will not include the SDTM operational data in the USDM JSON but can include a feature at a later date the support SDTM dataset creation in the Workbench UI.

0 replies

pendingintent · 2026-05-22T08:32:42Z

pendingintent
May 22, 2026
Maintainer Author

I intend to include CRF specializations in the USDM JSON as extensionAttributes initially to support the work of other projects and will explore using extensionAttributeClass to further enhance in the future.

0 replies

How to properly represent data set specialization with a BC #206

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