Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
Info
titleNews and updates
  • 2024-04-02: 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

    Expand
    titleHistory Prior to 2023...
    • 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
bordertrue
Column

Status
subtletrue
colourYellowRed
titleUpdated
The fourth batch of biomedical concepts is included in
Important
Introduced as part of the 2023-07-06 release. For detailed information, go to , the base path URL for BC API endpoints have changed with versioning. The endpoints remain unchanged. See technical details in Biomedical Concepts & Specializations.

Section
bordertrue
Column

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

...

Section
bordertrue
Column

The URL for Data Standards Browser is:

Code Block
linenumberstrue
https://library.cdisc.org/browser
Section
bordertrue
colourCDISC 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.

Column
Status

Green
titleNew
Code Block
linenumberstrue
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.

...

Section
bordertrue
Column
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
colourYellow
titleupdated
The following standards have been loaded:

  • CDISC Controlled Terminology P19 (2014-09-26) to P54 P57 (20222024-0603-3029)*, a total of 35 quarters 38 publications with 160 176 parts
  • CDASH v1.1.1/CDASHUG v1.0, CDASH Model v1.0 to v1.23, CDASHIG v2.0 to v2.23
  • 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 47*, a total of 300+ 302 BCs and specializations290 SDTM Dataset Specializations, including laboratory tests, vital signs, microbiology specimen tests, electrocardiogram measurements and findings, concomitant medications, procedures, adverse events, medical history, disposition events, biospecimen events and demographicsDraft content: ADaM popPK v1.0, CDASH Model v1.3, CDASHIG v2.3adverse 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 as of to the 20232024-0704-06 release02 releases

Section
bordertrue
Column

Status
colourYellow
titleUpdated
Included in the 20232024-0704-06 release are:

Enhancements

Feature

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 v2.3API for CDISC BC is now versioned.

Contents

  • 2023 Q2 2024 Q1 CT packages package (P54P57, dated 20232024-0603-3029): ADaM CT, DDF CT, Define-XML CT, MRCT CT, Protocol CT, SDTM CT, SEND CT.
  • CDISC BC & SDTM Specialization Package 4:
  • Oncology  RECIST 1.1 disease response criteria
  • New and updated BCs and SDTM specializationsCDISC BC & SDTM Specialization Package 7.

Data Standards Browser

  • N/A for this release.

Corrections & Patches

  • Updated template for Excel and CSV Exports for SDTM v1.8 and earlier.
  • ADaM exports now references "Variable Set" rather than "Variable Group".

Deprecations

  • N/A for this release.

Deprecations

  • N/A for this releaseDraft content for SENDIG-GeneTox v1.0 and SENDIG-DART v1.2 is deprecated.


Expand
titleReview information from previous release notes...

Enhancements

Feature

  • N/A for this release.

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 & 62023 Q1 CT packages (P53, dated 2023-03-31): ADaM CT, DDF CT, Protocol CT, SDTM CT, SEND CT.

Data Standards Browser

  • N/A for this release.

Corrections & Patches

  • N/A for this release.

Deprecations

  • N/A for this release.

...