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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.

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.

New requests or changes to existing Terminology can be accessed through the CDISC New Term Request Page.

Current Controlled Terminology Release - Update 21 Dec 2018

Release Date: 21 Dec 2018

As of 21 Dec 2018 the ADaM, CDASH, Glossary, SDTM, and SEND Controlled Terminology files have been updated on the NCI-EVS Ftp site. The version dates of the new files are 2018-12-21.  These terminology files replace all older ADaM, CDASH, Glossary, SDTM, and SEND files and include terms from Review Package 36. There are approximately 269 new QRS terms and 332 new terms across Glossary, SDTM, and SEND.

WARNING: During the production of CDISC Controlled Terminology Package 36, a text file with aberrant quotations was used to generate the odm.xml and OWL/RDF formats for ADaM, CDASH, Glossary, SDTM, and SEND terminologies. The .xls, .html, and .pdf formats were not affected. We have replaced the .txt, odm.xml, and OWL/RDF file formats for the 2018-12-21 publication. If you downloaded any files between 21 Dec 2018 and 7 Jan 2018, please disregard these files and use the updated ones.