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 Mar 2020

Release Date: 27 Mar 2020

As of 27 Mar 2020 the Protocol Entities, SDTM, SEND, Define-XML, and ADaM Controlled Terminology files have been updated on the NCI-EVS Ftp site. The version dates of the new files are 2020-03-27.  These terminology files replace all older Protocol Entities, SDTM, SEND, Define-XML, and ADaM files and include terms from Review Package 41. There are approximately 82 new QRS terms and 153 new terms across CDISC Glossary, Protocol Entities, SDTM, SEND, ADaM, and Define-XML. Additionally there are two new codetable mapping files and updates to six published codetable mapping files.