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titleNews and updates
  • 20212024-0904-29: 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
  • Expand
    titleHistory Prior to 2020...

    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

  • 02: 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
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General

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titleImportant
 A hot fix has occurred on 2021-09-28 19:00 Eastern Time to correct the path parameter for the Findings About class in CDASH v1.2 & CDASHIG v2.2. Instead of /mdr/cdash/1-2/classes/FindingsAboutEventsorInterventions/..., it is now /mdr/cdash/1-2/classes/FindingsAbout/.... The same applies to CDASHIG v2.2, such as /mdr/cdashig/2-2/classes/FindingsAbout/.... The dates in /mdr/lastupdated are also updated.

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titleImportant
The 2020-11-11 release is generally known as Next Generation CDISC Library, where CDISC begins to host CDISC Library in Microsoft Azure. To learn more, access the free course NGLIB001: Next Generation CDISC Library on CDISC Learning System 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 URL for Data Standards Browser is: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/browserapi/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.

The following standards have been loaded:

  • CDISC Controlled Terminology P19 (2014-09-26) to P47 (2021-09-24)*, a total of 29 quarters with 120 parts
  • CDASH v1.1.1/CDASHUG v1.0, CDASH Model v1.0 to v1.2, CDASHIG v2.0 to v2.2*
  • 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 v3.1.1, 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 2021-09-28 release

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.

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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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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
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titleUpdated
Included in the 2021-09-28 release are:

Enhancements

Feature

  • N/A for this release.

Contents

  • CDISC Controlled Terminology Q3 2021 publication (P47).
  • CDASH Model v1.2.
  • CDASHIG v2.2.
  • List of draft contents:
    • ADaMIG v1.3 (updated).
    • ADaM OCCDS v1.1 (updated).

Data Standards Browser

  • N/A for this release.

Corrections & Patches

  • For Excel and CSV exports:
    • General formatting touchups in the Excel templates.
    • For Protocol CT, updated the Excel Read Me to align the Extensible column's description with that in P47 publication.
    • For Glossary, updated Standard and Date column's description in the Excel Read Me.
    • For SDTMIG and SENDIG, the original "Controlled Terms, Codelist or Format" column is now split into three columns: 1) "CDISC CT Codelist Code(s)"; 2) "Described Value Domain(s)"; and 3) "Value List".
    • For CDASHIG, the column "Controlled Terminology Codelist Name" column is updated to "CDISC CT Codelist Code(s), Subset Codes(s)".
    • For CDASHIG, when a variable has multiple CDISC CT codelists, their c-codes are now displayed in the exports.

Deprecations

  • N/A for this release.
Expand
titleReview information from previous release notes...

Enhancements

Feature

  • QRS*, accessible via:
    • API endpoint.
    • Data Standards Browser.
  • ODM-XML support.

Contents

  • CDISC Controlled Terminology Q2 2021 publication (P46).
  • List of draft contents:
    • ADaM OCCDS v1.1 (new).
    • SDTM v2.0 (updated).
    • SDTMIG v3.4 (updated).

Data Standards Browser

  • Added a text search in the left navigation pane.
  • Updated to display multi-line text properly, e.g., CDISC Notes.
  • Applied word wrapping behavior to columns, e.g., Label.
  • Updated to show an error message when a Diff report can't be generated when there is nothing to compare with, i.e., no predecessor.

* For details, go to QRS Supplements to SDTMIG.

Corrections & Patches

  • "dataset" was incorrectly indexed as "datasetStructure". Fixed the indexer so that dataset names such as AE are searchable using the correct scope.
  • Excel and CSV export requests for ADaM v2.1 no longer creates an error. It is now showing 0 variables, which is the expected result.
  • SDTMIG-MD v1.1's predecessor was missing. It now has predecessor relationship to SDTMIG-MD v1.0.

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:

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/mdr/maintenance

For example,

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{
  "maintenanceMode": true,
  "maintenanceMessage": "CDISC Library is currently under a scheduled maintenance."
}

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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:

  • sdtmClassMappingTargets
  • sdtmDatasetMappingTargets
  • sdtmigDatasetMappingTargets
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titleNew
 For 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.

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