Controlled Terminology

Terminology Call for Public Review Package 27 - Comments Due by 15 July 2016


CDISC Controlled Terminology Package 27 is ready for public review. The public review package consists of 10 documents: 


  • CV*
  • General 
  • Laboratory Tests*
  • Oncology*
  • PGx
  • PK
  • Spectype/Speccond
  • 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 24 June 2016


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 24 June 2016 the SDTM and SEND Controlled Terminology files have been updated on NCI/EVS. The dates of the new files are 2016-06-24.  These terminology files replace all older SDTM and SEND files and include terms from Review Package 26. There are approximately 160 new QRS terms,  and 359 new terms across SDTM and SEND.

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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