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.
As of 26 Mar 2021 the CDASH, Define-XML, Protocol Entities, SDTM, and SEND Controlled Terminology files have been updated on the NCI-EVS Ftp site. The version dates of the new files are 2021-03-26. These terminology files replace all previous CDASH, Define-XML, Protocol Entities, SDTM, and SEND and include terms from Review Package 45. There are approximately 109 new QRS terms and 215 new terms across CDASH, Define-XML, Protocol Entities, SDTM, and SEND. Additionally, there are:
Updates to six published Codetable Mapping files: Oncology, RP, SC, TS, and VS
Updates to ‘Rules for All Codelists’ and ‘Rules for Lab, Unit, and MI’ terminology development rules documents
Update to Unit-UCUM Codetable Mapping file
Update to Controlled Terminology Requests Denied file
Update to the CDISC Terminology Publication Schedule
NOTE: The OWL format of the CDISC Controlled Terminology for SDTM, CDASH, Define-XML, SEND, and Protocol terminology files posted on 2021-03-26 contains an incorrect namespace, causing problematic path data. This issue was identified and has been rectified by recreation of the OWL files with the correct namespace and re-posting of the files to the NCI Ftp on 2021-04-16. The issue does not affect CT content within the file. You may download the updated OWL files posted 16 Apr 2021 if the incorrect namespace information caused problems previously.