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 are available for direct download on this page.
As of 18 December 2015 the SDTM and SEND Controlled Terminology files have been updated on NCI/EVS. The dates of the new files are 2015-12-18. These terminology files replace all older SDTM, SEND, and QRS terminology files and include terms from Review Package 24. There are approximately 111 new QRS terms and 503 new terms across SDTM and SEND.
Reinstatement of Codelists for the SEND VS Domain:
To ensure compatibility with SENDIG 3.0, the following codelists will be republished in the SEND controlled terminology publication on 2015-12-18 for use with the Vital Signs (VS) domain: VSTEST, VSTESTCD, and VSRESU. Accompanying reintroduction of these codelists into SEND, the SVSTST and SVSTSTCD codelists (which are subsets of VSTEST and VSTESTCD) are being retired in the SEND controlled terminology publication on 2015-12-18. It will continue to be the responsibility of the submitting organization to use the most appropriate domain for the data being transmitted.
Questionnaires, Ratings, and Scales (QRS) Terminology:
Keeping the QRS codelists separate from the SDTM codelists was a decision based on the limits of excel spreadsheets. This decision has been reversed, and we will be merging the QRS codelists into the SDTM publication on 2015-12-18. The only content change will be in the codelist long name. Currently the long name starts with QS-, or FT-, or CC-. This prefix will be removed from the codelist long name only.
CDISC Clinical Data Element Glossary:
CDISC's Clinical Data Element Glossary contains terms that were created to support an early version of a cardiovascular therapeutic area user guide which was not formally published. The Clinical Data Element Glossary has been deprecated, and will be retired on 2015-12-18.
CDISC Controlled Terminology is also available through CDISC eSHARE.
Please post any comments, questions or suggestions to CDISC’s Public Discussion Forum.