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Controlled Terminology

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. 

Controlled Terminology Release

Release Date: 31 Mar 2017

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 31 March 2017 the SDTM, ADaM, SEND and Protocol Entities Controlled Terminology files have been updated on the NCI-EVS Ftp site. The dates of the new files are 2017-03-31.  These terminology files replace all older SDTM, ADaM, and SEND files and include terms from Review Package 29. Protocol Entities is a brand new CDISC terminology set. There are approximately 111 new QRS terms and 241 new terms across SDTM, ADaM, SEND and Protocol Entities.


CDISC Terminology Test Code/Test Name Codelist or Parameter Code/Parameter Name Codelist

The common factor between the matching terms in Test Code and Test Name codelists (or parameter code and parameter name codelists) is the NCIt C-code, which is found in the first column of the published terminology. The NCIt C-code for the term in the test code or parameter code codelist is exactly the same as the NCIt C-code for the same term in the test name or parameter name codelist. CDISC recommends using the NCIt C-codes in column A of the publication files to sort and filter such that the test code and test name (or parameter code and parameter name) for the same concept can be found together.

CDISC does not recommend using the synonym column to find the appropriate test name or parameter name associated with the test code or parameter code. While it is true that all test name and parameter name terms are added as synonyms by default, there are many test or parameter concepts that have multiple synonyms; these synonyms are published alphabetically.  Additionally, CDISC reserves the right to add additional synonyms when necessary or requested. It is therefore impossible to know which synonym is identical to the published test name or parameter name. 

Description of an NCIt C-Code:  A unique and permanent alphanumeric identifier attached to each concept within the NCI Thesaurus (NCIt), which is randomly generated by the NCI-EVS database tool Protégé. The code begins with a capital C followed by digits and carries no information other than to provide a machine readable piece of identification for each NCIt concept.