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Info
titleNews and updates
  • 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


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    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


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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 A hotfix 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.



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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.



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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.



The base URL for the API is:

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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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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.

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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:


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 P46 (2021-06-28)*, a total of 28 quarters with 115 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 v3.1.1, 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 2021-06-28 release



  • CDISC Controlled Terminology P19 (2014-09-26) to P46 (2021-06-28)*, a total of 28 quarters with 115 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 v3.1.1, 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 2021-06-28 release

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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.


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titleReview information from previous release notes...
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Included in the 2021-06-28 release are:

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
Expand
titleReview information from previous release notes...

Enhancements

  • Diff*
    • API endpoint
    • Report as an export from Data Standards Browser

* For details, go to Diff

Corrections & Patches

  • N/A for this releaserelationship to SDTMIG-MD v1.0.

Deprecations

  • N/A for this release



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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:, 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



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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:

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"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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