Changes Coming in December 2015


Questionnaires, Ratings, and Scales (QRS) Terminology

Keeping the QRS codelists separate from the SDTM codelists was a decision based on the limits of excel spreadsheets.   This decision has been reversed and we will be merging the QRS codelists into the SDTM publication at the end of 2015.  The only content change will be in the codelist long name.  Currently the long name starts with QS-, or FT-, or CC-.  This prefix will be removed from the codelist long name only. 


CDISC Clinical Data Element

CDISC's Clinical Data Element Glossary contains terms that were created to support an early version of a cardiovascular therapeutic area user guide that was ultimately left unpublished.  The Clinical Data Element Glossary has been deprecated, and will be retired at the end of 2015.

Controlled Terminology

Terminology Call for Public Review Package 24 - Comments Due by 9 October 2015


CDISC Controlled Terminology Package 24 is ready for public review. The public review package consists of 10 spreadsheets: 


- Device


- General 

- Laboratory Tests*

- Oncology*

- PGx

- PK*

- SEND* 

- Units of Measure*

- Virology* 


An Asterisk * indicates that changes to previously existing CDISC Submission Values are also included on the “Changes to Existing” tab in the spreadsheet.  Please review these changes.

Use this link to register/login to the Tracker so you can access the review documents.

CDISC will be using the Public Comment Tracker on the CDISC Portal for this review. Click here for directions on how to access and use the Public Comment Tracker Tool.

Detailed information on using the tracker can also be found via “Help” after clicking on Public Comment Tracker.

CDISC Controlled Terminology is the set of CDISC-developed or CDISC-adopted standard expressions (values) used with data items within CDISC-defined datasets. The CDISC Terminology Team, in collaboration with the National Cancer Institute's Enterprise Vocabulary Services (EVS), supports the controlled terminology needs of all CDISC foundational standards (SDTM (Drugs and Devices), CDASH, ADaM, SEND) and all CFAST disease/therapeutic area standards. 



Current Controlled Terminology Release - Update 25 September 2015


CDISC Controlled Terminology is maintained and distributed as part of NCI Thesaurus on an NCI File Transfer Protocol (FTP) site and is available for direct download on this page.  It is available in Excel, text, odm.xml, pdf, html and OWL/RDF formats.  

New requests or changes to existing terminology can be accessed through the NCI/EVS New Term Request Page and is available for direct download on this page.

As of 25 September 2015 the SDTM, SEND, and Questionnaires, Ratings, and Scales (QRS) Controlled Terminology files have been updated on NCI/EVS. The dates of the new files are 2015-09-25. These terminology files replace all older SDTM, SEND, and QRS terminology files and include terms from Review Package 23. There are approximately 66 new QRS terms and 239 new terms across SDTM and SEND files.


The Clinical Outcome Assessment (COA) Terminology file is now changed to Questionnaires, Ratings, and Scales (QRS) Terminology on the NCI/EVS website and contains new links. 

CDISC Controlled Terminology is also available through CDISC eSHARE.

Please post any comments, questions or suggestions to CDISC’s Public Discussion Forum.


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