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.
As of 18 Dec 2020 the Protocol Entities, SDTM, SEND, CDASH, Glossary, and Define-XML Controlled Terminology files have been updated on the NCI-EVS Ftp site. The version dates of the new files are 2020-12-18. These terminology files replace all older Protocol Entities, SDTM, SEND, CDASH, Glossary, and Define-XML and include terms from Review Package 44. There are approximately 307 new QRS terms and 235 new terms across Protocol Entities, SDTM, SEND, CDASH, Glossary, and Define-XML. Additionally there are updates to 6 published Codetable Mapping files: DD, DS, RP, SC, TS, and VS.