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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 28 September 2018

P35
Release Date: 28 Sep 2018

As of 28 Sept 2018 the SDTM, SEND, Protocol, and CDASH Controlled Terminology files have been updated on the NCI-EVS Ftp site. The version dates of the new files are 2018-09-28.  These terminology files replace all older SDTM, SEND, Protocol, and CDASH files and include terms from Review Package 35. There are approximately 642 new QRS terms and 434 new terms across SDTM, SEND, and Protocol.