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
As of 30 Sept 2022 the CDASH, Define-XML, Protocol Entities, SDTM, and SEND Controlled Terminology files have been updated on the NCI-EVS Ftp site. A new subset of CDISC terminology, DDF Terminology, has been added to the support the Digital Data Flow project. The version dates of the new files are 2022-09-30. These terminology files replace all older CDASH, Define-XML, Protocol Entities, SDTM, and SEND terminology files and include terms from Review Package 51. There are approximately 53 new QRS terms and 867 new terms across CDASH, Define-XML, Protocol Entities, SDTM, and SEND terminology files. Additionally, there are:
- Update to 8 published Codetable Mapping file: GF, GI, MK, Racec_Ethnicc, RP, SC, TS, and VS
- New Codetable Mapping file: IG
- Update to QRS Naming and Business Rules
- Update to terminology development Rules for Lab, Unit, and MI
- Update to Unit-UCUM Codetable Mapping file
- Update to Controlled Terminology Requests Denied file
- Update to CDISC Terminology Publication Schedule
- Update to the SDTM and SEND paired view files