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.
The CDASH, Define-XML, Protocol Entities, SDTM, and SEND Controlled Terminology files have been updated on the NCI-EVS Ftp site with version dates of 2021-09-24. These files replace all previous CDASH, Define-XML, Protocol Entities, SDTM, and SEND and include terms from Review Package 47. There are approximately 31 new QRS terms and 512 new terms across CDASH, Define-XML, Protocol Entities, SDTM, and SEND. Additionally, there are updates to:
Eight published Codetable Mapping files: EG, GI, MK, Oncology, RP, SC, TS, and VS
The following CT Development Rules documents: Rules for All Codelists; Rules for Lab, Unit, and MI; Rules for Oncology