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 29 September 2023, the DDF, 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 2023-09-29. These terminology files replace all older DDF, Protocol Entities, SDTM, and SEND terminology files and include terms from Review Package 55. There are approximately 266 new QRS terms and 387 new terms across DDF, Protocol Entities, SDTM, and SEND terminology files. Additionally there are:
- Update to 7 published Codetable Mapping files: DS, EG, IS, RE, RP, SC, and TS
- Update to 4 Terminology Development Rules documents: IS, LB, MB and MS, and QRS
- 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