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 30 Sept 2022 the CDASH, Define-XML, Protocol Entities, SDTM, and SEND Controlled Terminology files have been updated on the NCI-EVS Ftp site. A new subset of CDISC terminology, DDF Terminology, has been added to the support the Digital Data Flow project. The version dates of the new files are 2022-09-30. These terminology files replace all older CDASH, Define-XML, Protocol Entities, SDTM, and SEND terminology files and include terms from Review Package 51. There are approximately 53 new QRS terms and 867 new terms across CDASH, Define-XML, Protocol Entities, SDTM, and SEND terminology files. Additionally, there are:
Update to 8 published Codetable Mapping file: GF, GI, MK, Racec_Ethnicc, RP, SC, TS, and VS
New Codetable Mapping file: IG
Update to QRS Naming and Business Rules
Update to terminology development Rules for Lab, Unit, and MI
Update to Unit-UCUM Codetable Mapping file
Update to Controlled Terminology Requests Denied file