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.
As of 16 Dec 2022 the CDASH, Define-XML, DDF, CDISC Glossary, 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 2022-12-16. These terminology files replace all older CDASH, Define-XML, DDF, CDISC Glossary, Protocol Entities, SDTM, and SEND terminology files and include terms from Review Package 52. There are approximately 431 new QRS terms and 391 new terms across CDASH, Define-XML, DDF, CDISC Glossary, Protocol Entities, SDTM, and SEND terminology files. Additionally there are:
Update to 5 published Codetable Mapping file: DS, MK, Oncology, RP, and VS
*New Codetable Mapping File: IS
Update to Terminology Development Rules documents: QRS Naming and Business Rules; Rules for Lab, Unit, and MI; Rules for PK; Rules for Microbiology
*New Terminology Development Rules document: Rules for Immunogenicity Specimen Tests
Update to Unit-UCUM Codetable Mapping file
Update to Controlled Terminology Requests Denied file