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.
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.
New requests or changes to existing Terminology can be accessed through the CDISC New Term Request Page.
Controlled Terminology Release - Update 27 March 2026
As of 27 March 2026 the ADaM, CDASH, DDF, Define-XML, SDTM, and SEND Controlled Terminology files have been updated on the NCI-EVS Ftp site. The version dates of the new files are 2026-03-27. These terminology files replace all older ADaM, CDASH, DDF, Define-XML, SDTM, and SEND terminology files and include terms from Review Package 61.
There are approximately 248 new QRS terms and 1124 new terms across ADaM, CDASH, DDF, Define-XML, SDTM, and SEND terminology files. Additionally, there are:
• Update to 10 published Codetable Mapping files: EG, GI, IS, MK, Oncology, Race-Ethnic, RE, RP, TS, VS
• Addition of 1 new Codetable Mapping file: DV
• Update to 3 Terminology Development Rules document: QRS; Rules for Lab, Unit, and MI; Rules for Oncology
• Update to Unit-UCUM Codetable Mapping file
• Update to Controlled Terminology Requests Denied file
• Update to CDISC Terminology Publication Schedule
• Update to the ADaM, SDTM, and SEND paired view files
The CDISC protocol terminology was retired with the 2026-03-27 CDISC publication; older files will continue to be made available in the Archive folder of the NCI Ftp. The CDISC Protocol terminology has been superseded by the ICH M11 Protocol terminology. Refer to the CDISC website for more information and access to the ICH terminologies: https://www.cdisc.org/standards/terminology/cdisc-ich
Click here to explore our catalog of Controlled Terminology virtual and on-demand trainings.