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 17 Dec 2021 the CDISC Glossary, ADaM, 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 2021-12-17. These terminology files replace all older CDISC Glossary, ADaM, CDASH, Protocol Entities, SDTM, and SEND terminology files and include terms from Review Package 48. There are approximately 1212 new QRS terms and 526 new terms across CDISC Glossary, ADaM, CDASH, Define-XML, Protocol Entities, SDTM, and SEND terminology files. Additionally there are:
Updates to 6 published Codetable Mapping files: DD, DS, EG, Oncology, RP, and TS
Update to Unit-UCUM Codetable Mapping file
Update to Controlled Terminology Requests Denied file
Update to the CDISC Terminology Publication Schedule