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 - Update 27 September 2024
As of 27 Sept 2024 the ADaM, CDASH, DDF, Define-XML, CDISC Glossary, MRCT Glossary, 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 2024-09-27. These terminology files replace all older ADaM, CDASH, DDF, Define-XML, CDISC Glossary, MRCT Glossary, Protocol Entities, SDTM, and SEND terminology files and include terms from Review Package 58.
Additionally, a new terminology subset is being published with P58. The CDISC TMF reference model standardizes the structure, nomenclature, and metadata associated with a reference definition for electronic trial master file content. Use this reference model to maintain and store trial related documents, images and content. This initial publication contains 297 terms across 13 codelists.
There are approximately 809 new QRS terms and 1713 new terms across ADaM, DDF, Define-XML, CDISC Glossary, MRCT Glossary, Protocol Entities, SDTM, and SEND terminology files. Additionally there are:
- Update to 12 published Codetable Mapping files: EG, GF, IS, Oncology, Race-Ethnic, RP, SC, SR, SS, TS, UR, VS
- Update to 2 Terminology Development Rules document: IS; LB
- 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 27 September 2024
Click here to explore our catalog of Controlled Terminology virtual and on-demand trainings.