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.

Current Controlled Terminology Release - Update 29 Mar 2019

Release Date: 29 Mar 2019

As of 29 March 2019 the ADaM, CDASH, 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 2019-03-29.  These terminology files replace all older ADaM, CDASH, Protocol Entities, SDTM, and SEND files and include terms from Review Package 37. There are approximately 6 new QRS terms and 274 new terms across ADaM, Protocol Entities, SDTM and SEND.