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 25 Jun 2021, the CDASH, Define-XML, Protocol Entities, SDTM, and SEND Controlled Terminology files have been updated on the NCI-EVS Ftp site. The version dates of the new files are 2021-06-25. These terminology files replace all previous CDASH, Define-XML, Protocol Entities, SDTM, and SEND and include terms from Review Package 46.
The release comprises approximately 406 new QRS terms and 258 new terms across CDASH, Define-XML, Protocol Entities, SDTM, and SEND. Additionally, there are:
Updates to 3 published Codetable Mapping files: Oncology, Race-Ethnic, SC
Addition of 4 new Codetable Mapping files: GI, MK, SR, and UR
Updates to “QRS Naming and Business Rules” terminology development rules documents
Update to Unit-UCUM Codetable Mapping file
Update to Controlled Terminology Requests Denied file
Update to the CDISC Terminology Publication Schedule