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 08 May 2020

Release Date: 8 May 2020

As of 08 May 2020 the SDTM, SEND, CDASH, and CDISC Glossary Controlled Terminology files have been updated on the NCI-EVS Ftp site. The version dates of the new files are 2020-05-08.  These terminology files replace all older SDTM, SEND, CDASH, and CDISC Glossary files and include terms to support the CDISC Interim User Guide for COVID-19 and the CDISC Guidance for Ongoing Studies Disrupted by COVID-19 Pandemic.

There are approximately 37 new QRS terms and 65 new terms across SDTM, SEND, CDASH, and CDISC Glossary. Additionally, there are updates to four published codetable mapping files (RACEC_ETHNICC, SC, TS, and VS) and an update to the Unit-UCUM Mapping file.