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.
CDISC has released an out-of-cycle package of Controlled Terminology to correct an error in a submission value in the VSTEST codelist in SDTM and SEND Terminology files. The updated files are posted to the NCI-EVS Ftp site with the version date of 2020-11-06.
No changes have been made to the CDASH, Protocol Entities, Define-XML, and ADaM Controlled Terminology files; however these files have been up-versioned to allow sponsors to load the complete package of Controlled Terminology, if desired.
This release replaces all previous SDTM, SEND, CDASH, Protocol Entities,Define-XML, and ADaM Controlled Terminology files and includes terms from Review Package 43.
Controlled Terminology Release 06 Nov 2020