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Info
titleNews and updates
    2020
  • 2024-
  • 07
  • 04-
  • 07
  • 02:
  • New contents, new endpoint, metadata adjustments for ADaM
  • 2020-02-14: New contents, new endpoints, editorial updates
  • 2019-11-18: New contents, bug fixes, minor browser patch
  • 2019-09-13: Data standards browser as a new functionality
  • 2019-07-18: Search API, CSV & Excel exports, new and updated contents, and documentation updates
  • 2019-04-10: New contents, XML media type (beta functionality), and document revision with new and updated information
  • 2019-02-15: Initial version
Section

General

  • BC, specialization content, metadata export enhancement & new CT with a new MRCT terminology package
  • 2024-01-09: New CT and BC & specialization content
  • Expand
    titleHistory Prior to 2024...
    • 2023-12-12: New BC & specialization content
    • 2023-11-08: New content: CDASH Model v1.3 and CDASHIG v2.3
    • 2023-10-12: New content: ADaM popPK v1.0 
    • 2023-10-03: New CT and BC & specialization content, new endpoints added to BC API v2
    • 2023-07-06: New CT and BC & specialization content, new API version for accessing BCs & specializations, export bug fixes, and removal of SEND draft content
    • 2023-04-04: New content: 2023 Q1 CT packages, additional CDISC Biomedical Concepts (BC) and related SDTM dataset specializations
    • 2023-01-10: New content: 2022 Q4 CT packages, minor bug fixes

    • 2022-12-07: Added support for CDISC Biomedical Concepts (BC) and related SDTM dataset specializations
    • 2022-10-04: New content: 2022 Q3 CT packages, with a new DDF terminology package; access to informative content as beta feature
    • 2022-06-28: New content: 2022 Q2 CT packages, SENDIG-DART v1.2 as draft content, 6 new QRS Supplements with response metadata
    • 2022-03-29: New content: 2022 Q1 CT packages, enhancements for ADaMIG
    • 2022-01-04: New content: 2021 Q4 CT packages

    • 2021-11-28: New contents
    • 2021-09-29: Added notes about a hot fix
    • 2021-09-28: New contents
    • 2021-06-28: New contents, new endpoints, new features
    • 2021-05-04: Added diff functionality
    • 2021-03-30: New contents, editorial updates
    • 2020-11-11: Next Generation CDISC Library
    • 2020-07-07: New contents, new endpoint, metadata adjustments for ADaM
    • 2020-02-14: New contents, new endpoints, editorial updates
    • 2019-11-18: New contents, bug fixes, minor browser patch
    • 2019-09-13: Data standards browser as a new functionality
    • 2019-07-18: Search API, CSV & Excel exports, new and updated contents, and documentation updates
    • 2019-04-10: New contents, XML media type (beta functionality), and document revision with new and updated information
    • 2019-02-15: Initial version
Section

General

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titleImportant
Introduced as part of the 2023-07-06 release, the base path URL for BC API endpoints have changed with versioning. The endpoints remain unchanged. See technical details in Biomedical Concepts & Specializations.

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All access inquires, technical support tickets, comments, and general CDISC Library questions, please use the CDISC Library Product Inquiry form.

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The base URL for the API is:

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https://library.cdisc.org/api
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The URL for Data Standards Browser is:

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https://library.cdisc.org/browser
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CDISC Biomedical Concept (BC) API endpoints are now versioned, a change that was introduced in the release on 2023-07-06. For more information, go to Biomedical Concepts & Specializations.

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https://library.cdisc.org/api/cosmos/v2
https://library.cdisc.org/api/cosmos/v1

Note that v2 endpoints are recommended. v1 is for legacy support. A 404 HTTP error will occur when attempting to access BC endpoints without specifying the version.

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The CDISC Library API generally follows HTTP/1.1's guidelines for status code. Details are here: HTTP Status Codes.

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The REST API uses API key authentication.

Note, support for Basic Auth is deprecated as of the 2020-11-11 release. For an interactive walk-through, refer to the video posted on https://www.cdisc.org/cdisc-library/getting-started, starting at 00:44:38.

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Info

Content for CDISC Controlled Terminology P43 is available as a patch release dated 2020-11-06. It consists of contents published on 2020-09-25 plus transactional updates from the version dated 2020-11-06.

An update to the odm-xml schema file is introduced with CDISC Controlled Terminology P49. Version 1.2.0 of the XML schema file on CDISC GitHub DataExchange-CT repo, at https://github.com/cdisc-org/DataExchange-CT/tree/master/schema/ct-1.2.0.

Status
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titleupdated
The following standards have been loaded:

  • CDISC Controlled Terminology P19 (2014-09-26) to P57 (2024-03-29)*, a total of 38 publications with 176 parts
  • CDASH v1.1.1/CDASHUG v1.0, CDASH Model v1.0 to v1.3, CDASHIG v2.0 to v2.3
  • SDTM v1.2 to v2.0, SDTMIG v3.1.2 to v3.4, SDTMIG-AP v1.0, SDTMIG-MD v1.0, SDTMIG-MD v1.1
  • SENDIG v3.0, SENDIG v3.1.1, SENDIG-DART v1.1, SENDIG-AR v1.0
  • ADaM v2.1, ADaMIG v1.0 to v1.3, ADaM ADAE v1.0, ADaM TTE for BDS v1.0, ADaM OCCDS v1.0 to v1.1, ADaMIG MD v1.0, ADaMIG NCA v1.0, ADaM popPK v1.0
  • QRS Supplements to SDTMIG: AIMS, APACHE II, ATLAS, HAM-A, KFSS, KPS SCALE, SIX MINUTE WALK, CGI, PGI
  • Biomedical Concepts & SDTM Specializations Package 7*, a total of 302 BCs and 290 SDTM Dataset Specializations, including adverse events, death diagnosis/details, demographics, findings about cardiovascular events, genomics findings, imaging, inclusion/exclusion criteria, laboratory tests, medical history, medical procedures, product administration, subject characteristics, subject disposition events and substance use

* denotes new contents added to the 2024-04-02 releases

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All access inquires, technical support tickets, comments, and general CDISC Library questions, please use the CDISC Library Product Inquiry form.

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The base URL for the API is:

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https://library.cdisc.org/api
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The URL for Data Standards Browser is:

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https://library.cdisc.org/browser
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The CDISC Library API generally follows HTTP/1.1's guidelines for status code. Details are here: HTTP Status Codes (2020-02-14).

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The API uses Basic Auth (HTTP Basic Authentication).

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titleUpdated
The following standards have been loaded:

  • CDISC Controlled Terminology P19 (2014-09-26) to P42 (2020-06-26)*, a total of 24 quarters with 93 parts
  • CDASH v1.1.1/CDASHUG v1.0, CDASH Model v1.0 to v1.1, CDASHIG v2.0 to v2.1
  • SDTM v1.2 to v1.8, SDTMIG v3.1.2 to v3.3, SDTMIG-AP v1.0, SDTMIG-PGx v1.0, SDTMIG-MD v1.0, SDTMIG-MD v1.1
  • SENDIG v3.0, SENDIG v3.1, SENDIG-DART v1.1, SENDIG-AR v1.0
  • ADaM v2.1, ADaMIG v1.0 to ADaMIG v1.1 to v1.2, ADaM ADAE v1.0, ADaM TTE for BDS v1.0, ADaM OCCDS v1.0

* denotes new contents added as of the 2020-07-07 release

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titleUpdated
Included in the 2020-07-07 release are:

New contents

  • CDISC Controlled Terminology P41 (2020-03-27)
  • CDISC Controlled Terminology P42 (2020-06-26)
  • Note: See Clarifications about P41a (2020-05-08)

Enhancements

  • Added one endpoint (details below):
    • /mdr/maintenance
  • Added maintenance banner to the Data Standards Browser
  • For API Documentation:
    • Added examples
    • Added all supported media types for each endpoint
    • Enabled API mocking via Swagger virtual server
    • Enriched details for search related endpoints, i.e., schemas and query parameters
    • Added links to online resources
  • Added Media Type Support Matrix to the set of Release Notes

Corrections & Patches

Erroneous hypermedia links about valuelist have been removed from all ADaM responses Expand
titleExample using /mdr/adam/adamig-1-2/datastructures/BDS/variables/ABLFL

Before, valuelist hypermedia link in lines #11 to #14:

Code Block
linenumberstrue
{
    "ordinal": "316",
    "name": "ABLFL",
    ...
    "_links": {
        "self": {
            "href": "/mdr/adam/adamig-1-2/datastructures/BDS/variables/ABLFL",
            "title": "Baseline Record Flag",
            "type": "Analysis Variable"
        },
        "valuelist": {
            "href": "/mdr/adam/adamig-1-2/valuelist/CharacterYesResponse",
            "title": "Yes Response",
            "type": "Enumerated Value Domain"
        },
        "parentProduct": {
            "href": "/mdr/adam/adamig-1-2",
            "title": "Analysis Data Model Implementation Guide Version 1.2",
            "type": "Implementation Guide"
        },
        ...
        }
    }
}

After, valuelist no longer part of _links:

Code Block
linenumberstrue
{
    "ordinal": "316",
    "name": "ABLFL",
    ...
    "_links": {
        "self": {
            "href": "/mdr/adam/adamig-1-2/datastructures/BDS/variables/ABLFL",
            "title": "Baseline Record Flag",
            "type": "Analysis Variable"
        },
        "parentProduct": {
            "href": "/mdr/adam/adamig-1-2",
            "title": "Analysis Data Model Implementation Guide Version 1.2",
            "type": "Implementation Guide"
        },
        ...
        }
    }
}
ADaM TTE v1.0Corrected all malformed hypermedia links related to varsets Expand
titleExample from /mdr/adam/adam-tte-1-0/datastructures/ADTTE/varsets

Before, lines #11 and #16 have varsets href as /mdr/adam/adam-tte-1-0/datastructures/BDS/...:

Code Block
linenumberstrue
{
    "ordinal": "1",
    "name": "BDS for TTE",
    ...
    "_links": {
        "self": {
            ...
        },
        "analysisVariableSets": [
            {
                "href": "/mdr/adam/adam-tte-1-0/datastructures/BDS/varsets/SubjectIdentifierVariable",
                "title": "Subject Identifier Variable",
                "type": "Variable Set"
            },
            {
                "href": "/mdr/adam/adam-tte-1-0/datastructures/BDS/varsets/TreatmentVariables",
                "title": "Treatment Variables",
                "type": "Variable Set"
            },
            ...
            }
        ]
    }
}

After, varsets href values are corrected to read /mdr/adam/adam-tte-1-0/datastructures/ADTTE/...:

Code Block
linenumberstrue
{
    "ordinal": "1",
    "name": "BDS for TTE",
    ...
    "_links": {
        "self": {
            ...
        },
        "analysisVariableSets": [
            {
                "href": "/mdr/adam/adam-tte-1-0/datastructures/ADTTE/varsets/SubjectIdentifierVariable",
                "title": "Subject Identifier Variable",
                "type": "Variable Set"
            },
            {
                "href": "/mdr/adam/adam-tte-1-0/datastructures/ADTTE/varsets/TreatmentVariables",
                "title": "Treatment Variables",
                "type": "Variable Set"
            },
            ...
            }
        ]
    }
}
ADaM ADAE v1.0Corrected typo in TRTEMFL's description. Expand
titleDetails from /mdr/adam/adam-adae-1-0/datastructures/ADAE/variables/TRTEMFL

Before, typo in two instances of the inequality symbol >=:

Code Block
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{
    ...
    "description": "Example derivation: If ADSL.TRTSDT>=ASTDT>=ADSL.TRTEDT + x days then TRTEMFL='Y' The number x is defined by the sponsor and often incorporates the known half-life of the drug. Variable TRTEMFL is to be used for any analysis of treatment-emergent AEs. This variable is conditional on whether the concept of treatment emergent is a key feature of the AE analyses.",
    ...
}

After, the inequality symbol is corrected to <=:

Code Block
linenumberstrue
{
    ...
    "description": "Example derivation: If ADSL.TRTSDT<=ASTDT<=ADSL.TRTEDT + x days then TRTEMFL='Y' The number x is defined by the sponsor and often incorporates the known half-life of the drug. Variable TRTEMFL is to be used for any analysis of treatment-emergent AEs. This variable is conditional on whether the concept of treatment emergent is a key feature of the AE analyses.",
    ...
}
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/health

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For health check, use this endpoint to verify LDAP and database availability:

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titleNew
For system maintenance status, use this endpoint to obtain a flag indicating whether CDISC Library is under maintenance and a related system message:

Code Block
linenumberstrue
/mdr/maintenance

For example,

Code Block
linenumberstrue
{
  "maintenanceMode": true,
  "maintenanceMessage": "CDISC Library is currently under a scheduled maintenance."
}
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titleUpdated
Included in the 2024-04-02 releases are:

Enhancements

Feature

  • In addition to the Controlled Terminology Codelist Code, CDISC CT Codelist Submission Values are available in the exports and API for all SEND Implementation Guides, all ADaM Implementation Guides, and CDASHIG v2.3.

Contents

  • 2024 Q1 CT package (P57, dated 2024-03-29): ADaM CT, DDF CT, Define-XML CT, MRCT CT, Protocol CT, SDTM CT, SEND CT.
  • CDISC BC & SDTM Specialization Package 7.

Data Standards Browser

  • N/A for this release.

Corrections & Patches

  • N/A for this release.

Deprecations

  • N/A for this release.


Expand
titleReview information from previous release notes...

Enhancements

Feature

  • N/A

Contents

  • ADaM popPK v1.0, promoted from Draft Content to Final
  • CDASH Model v1.3 and CDASHIG v2.3, promoted from Draft Content to Final
  • CDISC BC & SDTM Specialization Packages 5 & 6

Data Standards Browser

  • N/A for this release.

Corrections & Patches

  • N/A for this release.

Deprecations

  • N/A for this release.
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For system maintenance status, use this endpoint to obtain a flag indicating whether CDISC Library is under maintenance and a related system message:

Column

For a machine-readable method to obtain a full listing of products loaded into the metadata repository use:

Code Block
linenumberstrue
/mdr/products

Or, by product group:

Code Block
firstline2
linenumberstrue
/mdr/products/{product-group}

where product-group is one of these values:

  • Terminology
  • DataCollection
  • DataTabulation
  • DataAnalysis
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Included in the 2020-02-14 release are two new endpoints, designed to provide high-level information about CDISC Library. These endpoints support both JSON and XML media types.

First, /mdr/about returns the URL for on-line API Documentation and Release Notes. It also includes a hypermedia link to a list of the product groups with their most recent update dates, as described below.

Code Block
linenumberstrue
/mdr/about
/mdr/lastupdated returns dates of last updated, organized by CDISC product group.

Code Block
linenumberstrue
/mdr/lastupdatedmaintenance

For example:,

/mdr/about example output
Code Block
title
linenumberstrue
{
  "_links": {
    "self": {
      "href": "/mdr/about",
      "title": "Information About CDISC Library"{
  "maintenanceMode": true,
      "typemaintenanceMessage": "About CDISC Library"
 is currently under },
a scheduled   "lastupdated": {
      "href": "/mdr/lastupdated",
      "title": "Last Update Date of CDISC Library Products",
      "type": "About CDISC Library"
    }
  },
  "release-notes": "https://wiki.cdisc.org/display/LIBSUPRT/Release+Notes",
  "api-documentation": "https://www.cdisc.org/cdisc-library/api-documentation"
}maintenance."
}
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For a machine-readable method to obtain a full listing of products loaded into the metadata repository use:

Code Block
linenumberstrue
/mdr/products

Or, by product group:

Code Block
firstline2
linenumberstrue
/mdr/products/{product-group}

where product-group is one of these values:

  • Terminology
  • DataCollection
  • DataTabulation
  • DataAnalysis
  • DraftContent*

* denotes new parameter added as of the 2021-03-30 release

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Included in the 2020-02-14 release are two new endpoints, designed to provide high-level information about CDISC Library. These endpoints support both JSON and XML media types.

First, /mdr/about returns the URL for on-line API Documentation and Release Notes. It also includes a hypermedia link to a list of the product groups with their most recent update dates, as described below.

Code Block
linenumberstrue
/mdr/about

/mdr/lastupdated returns dates of last updated, organized by CDISC product group.

Code Block
linenumberstrue
/mdr/lastupdated

For example:

Code Block
title/mdr/lastupdated about example output
linenumberstrue
{
  "_links": {
    "self": {
      "href": "/mdr/lastupdatedabout",
      "title": "LastInformation UpdateAbout Date of CDISC Library Products",
      "type": "About CDISC Library"
    },
    "lastupdated": {
  }     "href": "/mdr/lastupdated",
      "overalltitle": "2020-02-14Last Update Date of CDISC Library Products",
      "data-analysistype": "2020-02-14",
  "data-collection": "2020-02-14"About CDISC Library"
    }
  },
  "datarelease-tabulationnotes": "2019-11-18https://wiki.cdisc.org/display/LIBSUPRT/Release+Notes",
  "api-documentation"terminology": "2020-02-14https://www.cdisc.org/cdisc-library/api-documentation"
}
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title/mdr/lastupdated example output
linenumberstrue
{
  "_links": {
    "self": {
      "href": "/mdr/lastupdated",
      "title": "Last Update Date of CDISC Library Products",
      "type": "About CDISC Library"
    }
  },
  "overall": "2020-02-14",
  "data-analysis": "2020-02-14",
  "data-collection": "2020-02-14",
  "data-tabulation": "2019-11-18",
  "terminology": "2020-02-14"
Column

CDISC finished updating all internal (meta-model, URIs, etc.) and textual references of SHARE to CDISC Library. The base URL and API interface remain unaffected. User will find this update mostly in the value of _link/self/title and _links/self/label. For example:

Code Block
linenumberstrue
{
  "_links": {
    "self": {
      "href": "/mdr/products",
      "title": "CDISC Library Product List",
      "type": "CDISC Library Product List"
    },
  ...
}
Section

Media Type

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Added to the 20192021-0706-18 28 release is the support for two additional media types: CSV and Excel. Users may request top-level foundational standards exports in either CSV or Excel Workbook formatODM-XML, as a beta functionality. The media type for CSV ODM-XML is text/csv, while application/vnd.ms-excel for Excelapplication/odm+xml. For CDASHIG, users will receive an ODM v1.3.2 document as the response payload. For ADaMIG, SDTMIG, and SENDIG, user will receive a Define-XML v2.1 document.

Note

ODM-XML, CSV and Excel Workbook media types are only available at the top-level of a foundational standard. When requesting them at levels in any lower hierarchy, the API will return an HTTP 406 Not Acceptable status code.

CDISC Controlled Terminology in ODM-XML format is not yet supported. This is currently accessible through NCI EVS FTP site, here: https://evs.nci.nih.gov/ftp1/CDISC.

For example, a cURL snippet to obtain ADaM OCCDS v1.0 (lines #1-3), SDTMIG v3.3 (lines #5-7), and Controlled Terminology P38 .3 (lines #9#5-117) in CSV formatODM format. The outputs are in Define-XML v2.1:

Code Block
languagetext
linenumberstrue
curl -X GET \
  https://library.cdisc.org/api/mdr/adam/adam-occds-1-0 \
  -H 'Accept: textapplication/csvodm+xml'

curl -X GET \
  https://library.cdisc.org/api/mdr/sdtmig/3-3 \
  -H 'Accept: textapplication/csv'


odm+xml'

Another cURL snippet to obtain CDASHIG v2.1 in ODM format. The output is in ODM v1.3.2:

Code Block
languagetext
linenumberstrue
curl -X GET \
  https://library.cdisc.org/api/mdr/ct/packagescdashig/sdtmct-2019-06-282-1 \
  -H 'Accept: textapplication/csvodm+xml'
Similarly,

Below is a cURL snippet to obtain ADaM OCCDS v1.0 (lines #1-3), SDTMIG v3.3 (lines #5-7), and Controlled Terminology P38 (lines #9-11) in

Excel Workbook

CSV format:

Code Block
languagetext
linenumberstrue
curl -X GET \
  https://library.cdisc.org/api/mdr/adam/adam-occds-1-0 \
  -H 'Accept: application/vnd.ms-exceltext/csv'

curl -X GET \
  https://library.cdisc.org/api/mdr/sdtmig/3-3 \
  -H 'Accept: application/vnd.ms-exceltext/csv'


curl -X GET \
  https://library.cdisc.org/api/mdr/ct/packages/sdtmct-2019-06-28 \
  -H 'Accept: application/vnd.ms-excel'
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-H 'Accept: text/csv'

Similarly

Column
Added to the 2019-04-10 release is the XML media type, as a beta functionality. Users may now specify either JSON and XML to be the formatted API response. For example

, a cURL snippet to obtain

a list of content loaded in the metadata repository as JSON

ADaM OCCDS v1.0 (lines #1-3) , SDTMIG v3.3

) vs. XML

(lines #5-7), and Controlled Terminology P38 (lines

#5

#9-

7

11) in Excel Workbook format:

Code Block
languagetext
linenumberstrue
curl -X GET \
  https://library.cdisc.org/api/mdr/adam/adam-occds-1-0 \
  -H 'Accept: application/vnd.ms-excel'

curl -X GET \
  https://library.cdisc.org/api/mdr/mdrsdtmig/products3-3 \
  -H 'Accept: application/jsonvnd.ms-excel'

curl -X GET \
  https://library.cdisc.org/api/mdr/productsct/packages/sdtmct-2019-06-28 \
  -H 'Accept: application/xml'vnd.ms-excel'
Section

Draft Contents

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Starting 2021-03-30, users can access draft contents through CDISC Library. Draft contents are point-in-time snapshots, before they become official publication. Although may not be suitable for production use, draft contents are helpful toward evaluation and public reviewsFor input and suggestions about the XML media type beta functionality, please use the CDISC Library Product Inquiry form.

Section

Controlled Terminology

...

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The CDASH products include different types of mappings:

  • CDASH model class variables to SDTM class variables
  • CDASH model class variables to SDTM dataset variables
  • CDASH model domain variables to SDTM dataset variables
  • CDASH model domain variables to SDTMIG dataset variables
  • CDASHIG domain fields to SDTMIG dataset variables
  • CDASHIG domain fields to SDTM class variables
  • CDASHIG scenario fields to SDTMIG dataset variables

To accommodate the different types of mapping targets, three JSON array attributes had to be defined:mapping targets, three JSON array attributes had to be defined:

  • sdtmClassMappingTargets
  • sdtmDatasetMappingTargets
  • sdtmigDatasetMappingTargets
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For CDASH Model v1.2 and CDASHIG v2.2, where applicable:

  • Class description is added using definitions from CDISC CT.
  • Domain description is added using definitions from CDISC CT.
  • Class name is adjusted from "Findings About" to "Findings about Events and Interventions" to match source content, i.e., CDISC Wiki space.
  • sdtmClassMappingTargets
  • sdtmDatasetMappingTargets
  • sdtmigDatasetMappingTargets
Section

SDTM

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Variables in the SDTM occasionally have expanded text to describe a variable's role. This text is stored in "roleDescription" in the metadata repository. Otherwise, "roleDescription" matches "role", where "role" has a set of controlled values. Below is an example for the SDTM v1.5 variable SVUPDES:

Code Block
linenumberstrue
"ordinal": "11", 
"name": "SVUPDES", 
"label": "Description of Unplanned Visit", 
"description": "Description of what happened to the subject during an unplanned visit. Null for protocol-defined visits.", 
"role": "Qualifier", 
"roleDescription": "Optional Qualifier", 
...

...

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To promote consistency, the label "ISO 3166-1 Alpha-3" is used whenever this external country codelist is referenced. Similarly, "ISO 21090 NullFlavor enumeration" is used for null flavors.

Pagenav
Firsttrue