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 29 March 2024
As of 29 Mar 2024 the ADaM, DDF, 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 2024-03-29. These terminology files replace all older ADaM, DDF, Define-XML, Protocol Entities, SDTM, and SEND terminology files and include terms from Review Package 57.
Additionally, a new terminology subset is being published with P57. The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center), in collaboration with CDISC, have built a Clinical Research Glossary containing plain language definitions and other semantic artifacts for concepts commonly used in clinical research. If you’re a clinical researcher, patient, trial participant, caregiver, or patient advocate, this glossary helps to enhance health literacy and support the creation of empowering participant-facing research communications.
There are approximately 129 new QRS terms and 452 new terms across ADaM, DDF, Define-XML, MRCT, Protocol Entities, SDTM, and SEND terminology files. Additionally there are:
- Update to 14 published Codetable Mapping files: CV, DS, EG, GF, GI, IS, MK, Oncology, RE, RP, SC, SS, TS, and VS
- Update to 2 Terminology Development Rules document: IS; MB and MS
- 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
Controlled Terminology Release 29 March 2024
Click here to explore our catalog of Controlled Terminology virtual and on-demand trainings.