CDISC Controlled Terminology is the set of CDISC-developed or CDISC-adopted standard expressions (values) used with data items within CDISC-defined datasets. The CDISC Terminology Team, in collaboration with the National Cancer Institute's Enterprise Vocabulary Services (EVS), supports the controlled terminology needs of all CDISC Foundational Standards (SDTM (Drugs and Devices), CDASH, ADaM, SEND) and all CFAST disease/therapeutic area standards.
CDISC Controlled Terminology is maintained and distributed as part of NCI Thesaurus on an NCI File Transfer Protocol (FTP) site and is available for direct download on this 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 NCI/EVS New Term Request Page and is available for direct download on this page.
As of 25 March 2016 the SDTM, SEND, CDASH, and ADaM Controlled Terminology files have been updated on NCI/EVS. The dates of the new files are 2016-03-25. These terminology files replace all older SDTM, SEND, CDASH and ADaM files and include terms from Review Package 25. There are approximately 136 new QRS terms, 2 new ADaM terms, and 202 new terms across SDTM, SEND, and CDASH.
CDISC Controlled Terminology is also available through CDISC eSHARE.
Please post any comments, questions or suggestions to CDISC’s Public Discussion Forum.