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
As of 24 Jun 2022 the Protocol Entities, SEND, CDASH, SDTM, and ADaM Controlled Terminology files have been updated on the NCI-EVS Ftp site. The version dates of the new files are 2022-06-24. These terminology files replace all previous Protocol Entities, SEND, CDASH, SDTM, and ADaM Terminology files and include terms from Review Package 50. There are approximately 187 new QRS terms and 1045 new terms across Protocol Entities, SEND, CDASH, SDTM, and ADaM Terminology files.
Additionally there are:
- Update to one published Codetable Mapping file: TS
- Update to QRS Naming and Business Rules
- New terminology development rules document for Genomics team
- Update to Unit-UCUM Codetable Mapping file
- Update to Controlled Terminology Requests Denied file
- Update to CDISC Terminology Publication Schedule
- Update to the SDTM, SEND, and ADaM paired view files
Controlled Terminology Release 24 June 2022