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titleNews and updates
  • 2023-10-03: Package 5 (package 2023-10-03), new endpoints added to API v2
  • 2023-07-06: Package 4 (package 2023-07-06), new versioned APIs
  • 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)

...

Info
titleRelease Notes 2023-0710-0603

New CDISC Biomedical Concepts (BCs

) include a two layered approach:
  • Conceptual/abstract layer that provides standards-agnostic, unambiguous semantic definition largely based on  NCIt  concepts.
  • Implementation layer based on valid CDISC dataset specializations that provide value level metadata definitions that facilitate metadata-driven automation.

~300 draft CDISC BCs and SDTM Dataset Specializations are now retrievable via the CDISC Library API, including laboratory tests, vital signs, microbiology specimen tests, electrocardiogram measurements and findings, concomitant medications, procedures, adverse events, medical history, disposition events, biospecimen events  and demographics . Public Review is planned for later this year.

CDISC BCs and SDTM Dataset Specializations for RECIST 1.1 disease response criteria are also included in the package release as draft, pending Public Review.

CDISC BCs and SDTM Dataset Specializations are focused on addressing some of the true needs of implementers. For example, SDTM Dataset Specializations can be considered pre-configured building blocks that can be used to generate value level metadata, which is an important part of Define-XML. The Digital Data Flow project uses CDISC BCs to facilitate an efficient, metadata-driven study design process.

) and SDTM Dataset Specializations have been curated and released to production (package 5):

  • 36 BCs including laboratory tests, microbiology tests, and study product administration
  • 40 SDTM Dataset Specializations for the following domains: LB, MB, EC, MH, CM

In addition, a number of enhancements were made to existing content and API endpoints. CDISC Library now contains a total of 208 BCs and 171 SDTM Dataset Specializations retrievable via the CDISC Library API. Refer to Basic Construct section for endpoints marked new.

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Introduction

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

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Introduction

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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The base URL for the API is:

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Base URL for API Endpoints

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https://library.cdisc.org/api/cosmos/v2

Or, this one for legacy support:

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https://library.cdisc.org/api/cosmos/v1

Note that there has not been a target sunset date established yet.

...

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Basic Construct

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titleupdated

The The following table shows the basic construct of API request requests to obtain biomedical concepts:

API request templateAPI v2 Only?Return Latest Version Only?Description

/mdr/bc/packages



Get Biomedical Concept Package List

/mdr/bc/packages/{package}/biomedicalconcepts



Get Biomedical Concept List in a Package (example)

/mdr/bc/packages/{package}/biomedicalconcepts/{biomedicalconcept}



Get Biomedical Concept

The following table shows the basic construct of API request to obtain SDTM specializations:

Description
API request templatein a Package (example)

/mdr/

specializations/sdtm/packages

bc/biomedicalconcepts

Status
subtletrue
colourGreen
titleNew Endpoint

(tick)

(tick)

Get Biomedical Concept List (example)

Get SDTM Dataset Specialization Package List

/mdr/

specializations

bc/

sdtm

biomedicalconcepts/

packages/

{

package

biomedicalconcept}

/datasetspecializations
Get SDTM Dataset Specialization List

/mdr/specializations/sdtm/packages/{package}/datasetspecializations/{datasetspecialization}

Get SDTM Dataset Specialization

This is a table of supported parameters:

ParameterDescription
packagePackage Identifier. An ISO 8601 date.
biomedicalconceptBiomedical Concept Identifier. A string.
datasetspecializationSDTM Dataset Specialization Identifier. A string.
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Core Differences in BC API v2

These are the changes in the response payload from /mdr/bc/packages/{package}/biomedicalconcepts/{biomedicalconcept}:

  • Attribute name changes
    • $.category to $.categories
    • $.synonym to $.synonyms
    • $.resultScale to $.resultScales
  • Data type changes
    • $.resultScales returns from a scalar to a list
  • New attributes
    • $.ncitCode
    • $.dataElementConcepts.ncitCode
Info

Some examples are slightly modified to provide a better visual and flow. The examples are reflective of v2 endpoints.

Status
subtletrue
colourGreen
titleNew Endpoint

(tick)

(tick)

Get Biomedical Concept (example)

/mdr/bc/categories

Status
subtletrue
colourGreen
titleNew Endpoint

(tick)


Get Biomedical Concept Categories List (example)

/mdr/bc/biomedicalconcepts?category={category}

Status
subtletrue
colourGreen
titleNew Endpoint

(tick)

(tick)

Get List of Biomedical Concepts for a Given Category (example)

The following table shows the basic construct of API requests to obtain SDTM dataset specializations:

API request templateAPI v2 Only?Return Latest Version Only?Description

/mdr/specializations/sdtm/packages



Get SDTM Dataset Specialization Package List

/mdr/specializations/sdtm/packages/{package}/datasetspecializations



Get SDTM Dataset Specialization List in a Package (example)

/mdr/specializations/sdtm/packages/{package}/datasetspecializations/{datasetspecialization}



Get SDTM Dataset Specialization in a Package (example)

/mdr/specializations/sdtm/datasetspecializations

Status
subtletrue
colourGreen
titleNew Endpoint

(tick)

(tick)

Get SDTM Dataset Specialization List (example)

/mdr/specializations/sdtm/datasetspecializations/{datasetspecialization}

Status
subtletrue
colourGreen
titleNew Endpoint

(tick) (tick) Get SDTM Dataset Specialization (example)

/mdr/specializations/sdtm/domains

Status
subtletrue
colourGreen
titleNew Endpoint

(tick)
Get SDTM Dataset Specialization Domain List (example)

/mdr/specializations/sdtm/datasetspecializations?domain={domain}

Status
subtletrue
colourGreen
titleNew Endpoint

(tick)

(tick)

Get a List of SDTM Dataset Specializations for a Given Domain (example)

The following table shows the basic construct of API requests to obtain dataset specializations:

API request templateAPI v2 Only?Return Latest Version Only?Description

/mdr/specializations/datasetspecializations?biomedicalconcept={biomedicalconcept}

Status
subtletrue
colourGreen
titleNew Endpoint

(tick) (tick) Get a List of Dataset Specializations that Specialize a Biomedical Concept (example)

This is a table of supported parameters:

ParameterDescription
packagePackage Identifier. An ISO 8601 date.
biomedicalconceptBiomedical Concept Identifier. A string.
datasetspecializationSDTM Dataset Specialization Identifier. A string.
categoryBiomedical Concept Category. A string.
domainIdentifier for Dataset Specialization Domain. Examples: AE, DM, VS. A string.
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Core Differences in BC API v2

These are the changes in the response payload from /mdr/bc/packages/{package}/biomedicalconcepts/{biomedicalconcept}:

  • Attribute name changes
    • $.category to $.categories
    • $.synonym to $.synonyms
    • $.resultScale to $.resultScales
  • Data type changes
    • $.resultScales returns from a scalar to a list
  • New attributes
    • $.ncitCode
    • $.dataElementConcepts.ncitCode
Info

Some examples are slightly modified to provide a better visual and flow. The examples are reflective of v2 endpoints.

The JSON standard defines an object as "an unordered collection of zero or more name/value pairs." As such, the specific order in which object keys appear may vary in the response payload."

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Example 1

Get the biomedical concept list from the package released on October 26, 2022.

/mdr/bc/packages/2022-10-26/biomedicalconcepts

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{
    "_links": {
        "biomedicalConcepts": [
            {
                "href": "/mdr/bc/packages/2022-10-26/biomedicalconcepts/C25298",
                "title": "Systolic Blood Pressure",
                "type": "Biomedical Concept"
            },
            ...
         ],
         "self": {
            "href": "/mdr/bc/packages/2022-10-26/biomedicalconcepts",
            "title": "Biomedical Concepts",
            "type": "Biomedical Concept List"
        }
    },

Lines 3-10: A list of HATEOS links to biomedical concepts matching the package parameter, excerpted to show Systolic Blood Pressure.
Each biomedical concept has 3 elements: href, title, and type.

For an in-depth explanation of HATEOS refer to In-depth: HATEOAS Implementation in CDISC Library API for more information about hypermedia links.

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    "effectiveDate": "2022-10-26",
    "label": "Biomedical Concept Package Effective 2022-10-26",
    "name": "Biomedical Concepts 2022-10-26",
    "version": "2022-10-26"
}
Lines 17-20: Metadata about the biomedical concept list.
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Example 2

Get the one Systolic Blood Pressure biomedical concept from the package released on October 26, 2022.

/mdr/bc/packages/2022-10-26/biomedicalconcepts/C25298

Code Block
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{
    "_links": {
        "parentBiomedicalConcept": {
            "href": "/mdr/bc/packages/2022-10-26/biomedicalconcepts/C54706",
            "title": "Blood Pressure",
            "type": "Biomedical Concept"
        },
        "parentPackage": {
            "href": "/mdr/bc/packages/2022-10-26/biomedicalconcepts",
            "title": "Biomedical Concept Package Effective 2022-10-26",
            "type": "Biomedical Concept Package"
        },
        "self": {
            "href": "/mdr/bc/packages/2022-10-26/biomedicalconcepts/C25298",
            "title": "Systolic Blood Pressure",
            "type": "Biomedical Concept"
        }
    },

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, Blood Pressure is the parent to Systolic Blood Pressure. parentBiomedicalConcept will not be present for topmost biomedical concepts.

Lines 3-7: The latest version of the parent biomedical concept (Blood Pressure).

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     "categories": [
        "Vital Signs"
    ],
Lines 19-21: A list of categories to which this biomedical concept belongs.
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    "coding": [
        {
            "code": "8480-6",
            "system": "http://loinc.org/",
            "systemName": "LOINC"
        }
    ],
Lines 22-28: A list of external code systems to which this biomedical concept relates.
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    "dataElementConcepts": [
        {
            "conceptId": "C173522",
            "dataType": "integer",
            "href": "https://ncithesaurus.nci.nih.gov/...&code=C173522",
            "ncitCode": "C173522",
            "shortName": "Vital Signs Result"
        },
        {
            "conceptId": "C49669",
            "dataType": "string",
            "exampleSet": [
                "cmHg",
                "mmHG",
                "Pascal"
            ],
            "href": "https://ncithesaurus.nci.nih.gov/...&code=C49669",
            "ncitCode": "C49669",
            "shortName": "Unit of Pressure"
        },
        ...
    ],

Lines 29-50: A list of data element concepts that comprise this biomedical concept. The href value points to an NCI EVS Thesaurus resource where definition of this data element can be found via the concept code (or, commonly known as c-code).

Lines 31-35: Vital Signs Result (Line 35) is the first data element concept on the list.

Lines 38-47: Unit of Measure (Line 47) is the next data element concept on the list. An example set of values is provided in this example.

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    "conceptId": "C25298",
    "definition": "The maximum pressure exerted into the systemic arterial...",
    "href": "https://ncithesaurus.nci.nih.gov/...&code=C25298",
    "resultScales": [
        "Quantitative
    ],
    "ncitCode": "C25298",
    "shortName": "Systolic Blood Pressure",
    "synonyms": [
        "SYSBP"
    ]
}
Lines 51-61: Metadata about the biomedical concept.
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Example 3

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Get a list of all biomedical concepts across packages.

/mdr/bc/biomedicalconcepts

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{
    "_links": {
        "biomedicalConcepts": [
            {
                "href": "/mdr/bc/biomedicalconcepts/C25298",
                "title": "Systolic Blood Pressure",
                "type": "Biomedical Concept"
            },
            ...
        ],
        "self": {
            "href": "/mdr/bc/biomedicalconcepts",
            "title": "Biomedical Concepts (latest version)",
            "type": "Biomedical Concept List"
        }
    }, 
    "name": "Biomedical Concepts (latest version)",
    "label": "Biomedical Concepts List"
}

Lines 3-10: A list of HATEOS links to biomedical concepts, excerpted to show Systolic Blood Pressure.
Each biomedical concept has 3 elements: href, title, and type.

For an in-depth explanation of HATEOS refer to In-depth: HATEOAS Implementation in CDISC Library API for more information about hypermedia links.

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Example 4

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titleNew

Get the latest version of the Systolic Blood Pressure biomedical concept.

/mdr/bc/biomedicalconcepts/C25298

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{
    "_links": {
        "parentBiomedicalConcept": {
            "href": "/mdr/bc/biomedicalconcepts/C54706",
            "title": "Blood Pressure",
            "type": "Biomedical Concept"
        },
        "parentPackage": {
            "href": "/mdr/bc/packages/2023-07-06/biomedicalconcepts",
            "title": "Biomedical Concept Package Effective 2023-07-06",
            "type": "Biomedical Concept Package"
        },
        "self": {
            "href": "/mdr/bc/biomedicalconcepts/C25298",
            "title": "Systolic Blood Pressure",
            "type": "Biomedical Concept"
        }
    },
Lines 2-18: A list of  HATEOAS  links to related resources, such as self, parent package that has the latest version of this biomedical concept, and parent biomedical concept. A note on parent biomedical concept: In this example, Blood Pressure is the parent to Systolic Blood Pressure.  parentBiomedicalConcept  will not be present for topmost biomedical concepts.
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"categories": [
    "Vital Signs"
],
Lines 19-21: A list of categories to which this biomedical concept belongs.
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"coding": [
    {
        "code": "8480-6",
        "system": "http://loinc.org/",
        "systemName": "LOINC"
    }
],
Lines 22-28: A list of external code systems to which this biomedical concept relates.
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"dataElementConcepts": [
       {
           "conceptId": "C173522",
           "dataType": "decimal",
           "href": "https://ncithesaurus.nci.nih.gov/...&code=C173522",
           "ncitCode": "C173522",
           "shortName": "Vital Signs Result"
       },
       {
           "conceptId": "C49669",
           "dataType": "string",
           "exampleSet": [
               "cmHg",
               "mmHG",
               "Pascal"
           ],
           "href": "https://ncithesaurus.nci.nih.gov/...&code=C49669",
           "ncitCode": "C49669",
           "shortName": "Unit of Pressure"
       },
       ...
   ],

Lines 29-50: A list of data element concepts that comprise this biomedical concept. The href value points to an NCI EVS Thesaurus resource where definition of this data element can be found via the concept code (or, commonly known as c-code).

Lines 31-35: Vital Signs Result (Line 35) is the first data element concept on the list. 

Lines 38-47: Unit of Measure (Line 47) is the next data element concept on the list. An example set of values is provided in this example.

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    "conceptId": "C25298",
    "definition": "The maximum pressure exerted into the systemic arterial...",
    "href": "https://ncithesaurus.nci.nih.gov/...&code=C25298",
    "resultScales": [
        "Quantitative
    ],
    "ncitCode": "C25298",
    "shortName": "Systolic Blood Pressure",
    "synonyms": [
        "SYSBP"
    ]
}
Lines 51-61: Metadata about the biomedical concept.
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Example 5

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titleNew

Get a list of all the biomedical concept categories.

/mdr/bc/categories

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{
    "_links": {          
         "self": {
             "href": "/mdr/bc/categories",
             "title": "Biomedical Concept Categories",
             "type": "Biomedical Concept Category List"
         }
         "categories": [
            {
                "name": "Vital Signs",
                "_links": {
                    "self": {
                        "href": "/mdr/bc/biomedicalconcepts?category=Vital%20Signs",
                        "title": "Biomedical Concepts Category (Vital Signs)",
                        "type": "Biomedical Concepts Category"
                    }
                }
            },
            ...
        ],
     },
    "name": "Biomedical Concept Categories",
    "label": "Biomedical Concept Categories List"
}

Lines 8-20: A list of HATEOS links to biomedical concept categories, excerpted to show Vital Signs.
Each biomedical concept category has 3 elements: href, title, and type.

For an in-depth explanation of HATEOS refer to In-depth: HATEOAS Implementation in CDISC Library API for more information about hypermedia links.

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Example 6

Status
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titleNew

Get a list of the latest version of all biomedical concepts in the Vital Signs category.

/mdr/bc/biomedicalconcepts?category=Vital%20Signs

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{
    "_links": {
        "biomedicalConcepts": [
            {
                "href": "/mdr/bc/biomedicalconcepts/C25298",
                "title": "Systolic Blood Pressure",
                "type": "Biomedical Concept"
            },
            ...
        ],
        "self": {
            "href": "/mdr/bc/biomedicalconcepts",
            "title": "Biomedical Concepts (latest version)",
            "type": "Biomedical Concept List"
        }
    },

Lines 3-10: A list of HATEOS links to biomedical concepts in the Vital Signs category, excerpted to show Systolic Blood Pressure.
Each biomedical concept has 3 elements: href, title, and type.

For an in-depth explanation of HATEOS refer to In-depth: HATEOAS Implementation in CDISC Library API for more information about hypermedia links.

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    "name": "Biomedical Concepts (latest version)",
    "category": "Vital Signs",
    "label": "Biomedical Concepts List"
} 
Lines 17-20: Metadata about the biomedical concept category list.
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Example 7

Status
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titleNew

Get the SDTM dataset specialization list from the package released on October 26, 2022.

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

Code Block
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{
    "_links": {
        "self": {
            "href": "/mdr/specializations/sdtm/...datasetspecializations",
            "title": "SDTM Dataset Specializations",
            "type": "SDTM Dataset Specialization list"
        },
        "datasetSpecializations": [
            {
                "href": "/mdr/specializations/sdtm/...datasetspecializations/SYSBP",
                "title": "Systolic Blood Pressure",
                "type": "SDTM Dataset Specialization"
            },
            ...
        ]
    },
Lines 8-15: A list of SDTM dataset specializations matching the package parameter, excerpted to show Systolic Blood Pressure. Note the specialization type is set to "SDTM Dataset Specialization".
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    "effectiveDate": "2022-10-26",
    "label": "SDTM Dataset Specialization Package Effective 2022-10-26",
    "name": "SDTM Dataset Specializations 2022-10-26",
    "version": "2022-10-26"
}
Lines 17-20: Metadata about the SDTM dataset specialization list.
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Example 8

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

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{
    "_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.
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    "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.

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        {
            "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.

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    "datasetSpecializationId": "SYSBP",
    "domain": "VS",
    "sdtmigStartVersion": "3-2",
    "shortName": "Systolic Blood Pressure",
    "source": "VS.VSTESTCD"
}
Lines 63-67: Metadata about the SDTM dataset specialization.
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Example 9

Status
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titleNew

Get a list of all SDTM dataset specializations across packages.

/mdr/specializations/sdtm/datasetspecializations

Code Block
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{
    "_links": {
        "datasetSpecializations": [
            {
                "href": "/mdr/specializations/sdtm/datasetspecializations/SYSBP",
                "title": "Systolic Blood Pressure",
                "type": "SDTM Dataset Specialization"
            },
            ...
        ],
        "self": {
            "href": "/mdr/specializations/sdtm/datasetspecializations",
            "title": "SDTM Dataset Specializations (latest version)",
            "type": "SDTM Dataset Specializations List"
        }
    },
    "name": "SDTM Dataset Specializations (latest version)",
    "label": "SDTM Dataset Specializations List"
}

Lines 3-10: A list of SDTM dataset specializations, excerpted to show Systolic Blood Pressure.
Each SDTM dataset specialization has 3 elements: href, title, and type. For Refer to In-depth: HATEOAS Implementation in CDISC Library API for more information about hypermedia links.
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Example 10

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titleNew

Get the latest version of the Systolic Blood Pressure SDTM Dataset Specialization.

/mdr/specializations/sdtm/datasetspecializations/SYSBP

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languageyml
linenumberstrue
{
    "_links": {
        "parentBiomedicalConcept": {
            "href": "/mdr/bc/biomedicalconcepts/C25298",
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Example 1

Get biomedical concept list from the package released on October 26, 2022.

/mdr/bc/packages/2022-10-26/biomedicalconcepts

Code Block
languageyml
linenumberstrue
{
    "_links": {
         "self": {
            "href": "/mdr/bc/packages/2022-10-26/biomedicalconcepts",
            "title": "BiomedicalSystolic Blood ConceptsPressure",
            "type": "Biomedical Concept List"
        },
        "biomedicalConcepts": [
           "parentPackage": {
                "href": "/mdr/specializations/bcsdtm/packages/20222023-1007-2606/biomedicalconcepts/C25298datasetspecializations",
                "title": "Systolic Blood PressureSDTM Dataset Specialization Package Effective 2023-07-06",
                "type": "Biomedical ConceptSDTM Dataset Specialization Package"
         },
   },
     "self": {
      ...
        ],
     },

Lines 8-15: A list of biomedical concepts matching the package parameter, excerpted to show Systolic Blood Pressure. Each biomedical concept has 3 elements: href, title, and type. For Refer to In-depth: HATEOAS Implementation in CDISC Library API for more information about hypermedia links.

Code Block
languageyml
firstline17
linenumberstrue
"href": "/mdr/specializations/sdtm/datasetspecializations/SYSBP",
            "effectiveDatetitle": "2022-10-26Systolic Blood Pressure",
    "label": "Biomedical Concept Package Effective 2022-10-26",
    "nametype": "BiomedicalSDTM Concepts 2022-10-26",
Dataset Specialization"
       "version": "2022-10-26"
}
Lines 17-20: Metadata about the biomedical concept list.
Section
bordertrue
 }
    },

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
languageyml
firstline19
linenumberstrue
    "variables": [
        ...
        {
            "name": "VSORRESU",
            "dateElementConceptId": "C49669",
            "isNonStandard": false,
    
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Example 2

Status
colourYellow
titleUpdated
 Get the one Systolic Blood Pressure biomedical concept from the package released on October 26, 2022.

/mdr/bc/packages/2022-10-26/biomedicalconcepts/C25298

Code Block
languageyml
linenumberstrue
{
    "_links": {
        "parentBiomedicalConceptcodelist": {
                "hrefconceptId": "/mdr/bc/packages/2022-10-26/biomedicalconcepts/C54706C66770",
                "titlesubmissionValue": "Blood PressureVSRESU",
                "typehref": "Biomedical Concepthttps://ncithesaurus.nci.nih.gov/...&code=C66770"
        },
        "parentPackage": {},
            "hrefassignedTerm": "/mdr/bc/packages/2022-10-26/biomedicalconcepts",
{
                "titleconceptId": "C49670"Biomedical,
 Concept Package Effective 2022-10-26",
            "typevalue": "mmHg"Biomedical
   Concept Package"
        },
            "selfrole": {"Qualifier",
            "hrefrelationship": "/mdr/bc/packages/2022-10-26/biomedicalconcepts/C25298",
{
                "titlesubject": "Systolic Blood PressureVSORRESU",
                "linkingPhrase"type": "Biomedical Concept"
 : "is the unit for the value in",
       }
    },
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, Blood Pressure is the parent to Systolic Blood Pressure. parentBiomedicalConcept will not be present for topmost biomedical concepts.
Code Block
languageyml
firstline19
linenumberstrue
     "categoriespredicateTerm": [
  "IS_UNIT_FOR",
       "Vital Signs"
    ],
Lines 19-21: A list of categories to which this biomedical concept belongs.
Code Block
languageyml
firstline22
linenumberstrue
    "codingobject": [
"VSORRES"
           { },
            "codemandatoryVariable": "8480-6"true,
            "systemmandatoryValue": "http://loinc.org/"false,
            "systemNamevlmTarget": "LOINC"true
        }
    ],,

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

Lines 21-44: VSORRESU (Line 21) is a 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

Lines 22-28: A list of external code systems to which this biomedical concept relates

.

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languageymlthemeConfluenceyml
firstline2945
linenumberstrue
    "dataElementConcepts": [
        {
            "conceptIdname": "C173522VSSTRESN",
            "dataTypedateElementConceptId": "integerC173522",
            "hrefisNonStandard": "https://ncithesaurus.nci.nih.gov/...&code=C173522",
            "ncitCode": "C173522"false,
            "shortNamerole": "Vital Signs Result"
        },
        {Qualifier",
            "conceptIddataType": "C49669integer",
            "dataTypelength": "string"3,
            "exampleSetrelationship": [{
                "subject": "cmHgVSSTRESN",
                "linkingPhrase": "mmHGis the result of the test in",
                "predicateTerm": "PascalIS_RESULT_OF",
                 ],"object": "VSTESTCD"
            "href": "https://ncithesaurus.nci.nih.gov/...&code=C49669",
            "ncitCode": "C49669",
            "shortName": "Unit of Pressure"},
            "mandatoryVariable": false,
            "mandatoryValue": false,
        },
    "vlmTarget": true
   ...
    ], },
        ...
],
Lines 45-61: 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

Lines 29-50: A list of data element concepts that comprise this biomedical concept. The href value points to an NCI EVS Thesaurus resource where definition of this data element can be found via the concept code (or, commonly known as c-code).

Lines 31-35: Vital Signs Result (Line 35) is the first data element concept on the list.

Lines 38-47: Unit of Measure (Line 47) is the next data element concept on the list. An example set of values is provided in this example.
Code Block
languageyml
firstline5164
linenumberstrue
    "conceptId": "C25298",
    "definition": "The maximum pressure exerted into the systemic arterial...",
    "href": "https://ncithesaurus.nci.nih.gov/...&code=C25298",
    "resultScalesdatasetSpecializationId": ["SYSBP",
        "Quantitative
"domain": "VS",
     ]"sdtmigStartVersion": "3-2",
    "ncitCodesdtmigEndVersion": "C25298",
    "shortName": "Systolic Blood Pressure",
    "synonymssource": [
        "SYSBP"
    ]VS.VSTESTCD"
}
Lines 5164-6170: Metadata about the biomedical conceptSDTM dataset specialization.
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Anchor
example11
example11
Example

3

11

Status
colourGreen
titleNew

Get a list of all the SDTM dataset specialization list from the package released on October 26, 2022domains.

/mdr/specializations/sdtm/packages/2022-10-26/datasetspecializationsdomains

Code Block
languageyml
linenumberstrue
{
    "_links": {
        "self": {
            "href": "/mdr/specializations/sdtm/...datasetspecializationsdomains",
            "title": "SDTM Dataset Specializations Domains",
            "type": "SDTM Dataset Specializations SpecializationDomains listList"
        },
        "datasetSpecializations": [

    "domains": [
        {
             "name": "VS"
             "_links": {
                "self": {
                    "href": "/mdr/specializations/sdtm/...datasetspecializations/SYSBP/datasetspecializations?domain=VS",
                    "title": "Systolic Blood PressureSDTM Dataset Specialization Domain (VS)",
                    "type": "SDTM Dataset Specialization Domain"
            },
    }
        ...
    },
    ]
    },
Lines 8-15: A list of SDTM dataset specializations matching the package parameter, excerpted to show Systolic Blood Pressure. Note the specialization type is set to "SDTM Dataset Specialization".
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languageyml
firstline17
linenumberstrue

       "effectiveDate": "2022-10-26", ...
    "label": "SDTM Dataset Specialization Package]
 Effective 2022-10-26"   },
    "name": "SDTM Dataset Specializations 2022-10-26Domains",
    "label": "version": "2022-10-26"
}SDTM Dataset Specializations Domains List"
}

Lines 8-20: A list of HATEOS links to SDTM dataset specialization domains, excerpted to show VS.
Each biomedical concept category has 3 elements: href, title, and type.

For an in-depth explanation of HATEOS refer to In-depth: HATEOAS Implementation in CDISC Library API for more information about hypermedia links

Lines 17-20: Metadata about the SDTM dataset specialization list

.

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Anchor
example12
example12
Example

4

12

Status
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titleNew

Get the one Systolic Blood Pressure SDTM dataset specialization from the package released on October 26, 2022a list of the latest version of all SDTM dataset specializations in the VS domain.

/mdr/specializations/sdtm/packages/2022-10-26/datasetspecializations/SYSBP/sdtm/datasetspecializations?domain=VS

Code Block
languageyml
linenumberstrue
{
    "_links": {
        "parentBiomedicalConcept": {
            "href": "/mdr/bc/packages/2022-10-26/biomedicalconcepts/C25298",
            "title": "Systolic Blood Pressure",
            "type": "Biomedical Concept"
 datasetSpecializations": [
       },
     {
   "parentPackage": {
            "href": "/mdr/specializations/sdtm/...datasetspecializations/SYSBP",
                "title": "SDTM Dataset Specialization Package Effective 2022-10-26",
Systolic Blood Pressure",
                "type": "SDTM Dataset Specialization Package"
            },
            ...
        ],
        "self": {
            "href": "/mdr/specializations/sdtm/...datasetspecializations/SYSBP",
            "title": "Systolic Blood PressureSDTM Dataset Specializations (latest version)",
            "type": "SDTM Dataset Specializations SpecializationList"
        }
    },

Lines

2

3-

18

10: A list of

HATEOAS

HATEOS 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

SDTM dataset specializations in the VS domain, excerpted to show Systolic Blood Pressure.
Each biomedical concept has 3 elements: href, title, and type.

For an in-depth explanation of HATEOS refer to In-depth: HATEOAS Implementation in CDISC Library API for more information about hypermedia links.



Code Block
languageymlfirstline19
linenumberstrue
    "variables": [
        {
            "name": "VSORRESU",
SDTM Dataset Specializations          "dataElementConceptId": "C49669(latest version)",
            "isNonStandardlabel": false,
        "SDTM Dataset Specializations List",
    "mandatoryValuedomain": "VS"
}  
Lines 17-20: Metadata about the SDTM dataset specialization.
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example13
example13
Example 13

Status
colourGreen
titleNew

Get a list of the latest version of all dataset specializations that specialize the Glucose Measurement biomedical concept.

/mdr/specializations/datasetspecializations?biomedicalconcept=C105585

Code Block
languageyml
linenumberstrue
{
 false,
            "mandatoryVariable_links": true,
    {
        "roledatasetSpecializations": "Qualifier",{
            "relationshipsdtm": {[
                "linkingPhrase": "is the unit for the value in",
{
                    "objecthref": "VSORRES/mdr/specializations/sdtm/datasetspecializations/GLUCBLD",
                    "predicateTermtitle": "IS_UNIT_FORGlucose Concentration in Blood",
                    "subjecttype": "VSORRESU"
      "SDTM Dataset Specialization"
       },
          },
  "codelist": {
             {
   "conceptId": "C66770",
                "href": "https://ncithesaurus.nci.nih.gov/...&code=C66770",
/mdr/specializations/sdtm/datasetspecializations/GLUCPL",
                    "submissionValuetitle": "VSRESU"
Glucose Concentration in  Plasma",
        },
            "assignedTermtype": {
"SDTM      Dataset Specialization"
          "conceptId": "C49670",
     },
           "value": "mmHG"
    {
        },
            "vlmTargethref": true
"/mdr/specializations/sdtm/datasetspecializations/GLUCSER",
         },

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
        {
           "title": "Glucose Concentration in Serum",
                    "type": "SDTM Dataset Specialization"
               "name": "VSSTRESN" },
            "dataElementConceptId": "C173522",
     {
       "isNonStandard": false,
            "dataTypehref": "integer/mdr/specializations/sdtm/datasetspecializations/GLUCURIN",
            "length": 3,
        "title": "Glucose Concentration in "mandatoryValueUrine": false,
            "mandatoryVariable": false,
            "roletype": "QualifierSDTM Dataset Specialization",
            "relationship": {
   }
            ]
 "linkingPhrase": "is the result of the test in"},
        "parentBiomedicalConcept": {
            "objecthref": "VSTESTCD/mdr/bc/biomedicalconcepts/C105585",
                "predicateTermtitle": "IS_RESULT_OFGlucose Measurement",
                "subjecttype": "VSSTRESNBiomedical Concept"
            },
        "self": {
    "vlmTarget": true
        },
    "href": "/mdr/specializations/datasetspecializations?biomedicalconcept=C105585",
    ...
    ],

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
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firstline63
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    "datasetSpecializationIdtitle": "SYSBPDataset Specializations that specialize a Biomedical Concept",
            "domaintype": "VSDataset Specializations List",
        }
   "sdtmigStartVersion": "3-2" },
    "shortNamename": "Systolic Blood PressureDataset Specializations (latest version)",
    "sourcelabel": "VS.VSTESTCDDataset Specializations List"
}
Lines 634-67: Metadata about the SDTM dataset specialization25: A list of SDTM dataset specializations that specialize the Glucose Measurement biomedical concept (C105585).