CDISC Controlled Terminology is the set of CDISC-developed or CDISC-adopted standard expressions (values) used with data items within CDISC-defined datasets. 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.
CDISC Controlled Terminology is maintained and distributed as part of the NCI Thesaurus (ncit.nci.nih.gov) on an NCI File Transfer Protocol (FTP) site and is available for direct download from the cancer.gov CDISC terminology resources page. It is available in Excel, text, odm.xml, pdf, html and OWL/RDF formats.
New requests or changes to existing terminology can be accessed through the CDISC New Term Request Page, hosted by NCI-EVS. A link to the new term request page can be found on this site.
As of 28 Sept 2018 the SDTM, SEND, Protocol, and CDASH Controlled Terminology files have been updated on the NCI-EVS Ftp site. The version dates of the new files are 2018-09-28. These terminology files replace all older SDTM, SEND, Protocol, and CDASH files and include terms from Review Package 35. There are approximately 642 new QRS terms and 434 new terms across SDTM, SEND, and Protocol.