Controlled Terminology is the set of codelists and valid values used with data items within CDISC-defined datasets. Controlled Terminology provides the values required for submission to FDA and PMDA in CDISC-compliant datasets. Controlled Terminology does not tell you WHAT to collect; it tells you IF you collected a particular data item, how you should submit it in your electronic dataset.

CDISC, in collaboration with the National Cancer Institute's Enterprise Vocabulary Services (EVS), supports the Controlled Terminology needs of CDISC Foundational and Therapeutic Area Standards.

New requests or changes to existing Terminology can be accessed through the CDISC New Term Request Page.

Controlled Terminology Release - Update 27 Sept 2019

Release Date: 27 Sep 2019

As of 27 Sept 2019 the Protocol Entities, SDTM, and SEND Controlled Terminology files have been updated on the NCI-EVS Ftp site. The version dates of the new files are 2019-09-27.  These terminology files replace all older Protocol Entities, SDTM, and SEND files and include terms from Review Package 39. There are approximately 154 new QRS terms and 580 new terms across Protocol Entities, SDTM and SEND.