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 29 September 2023, the DDF, 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 2023-09-29. These terminology files replace all older DDF, Protocol Entities, SDTM, and SEND terminology files and include terms from Review Package 55. There are approximately 266 new QRS terms and 387 new terms across DDF, Protocol Entities, SDTM, and SEND terminology files. Additionally there are:
Update to 7 published Codetable Mapping files: DS, EG, IS, RE, RP, SC, and TS
Update to 4 Terminology Development Rules documents: IS, LB, MB and MS, and QRS
Update to Unit-UCUM Codetable Mapping file
Update to Controlled Terminology Requests Denied file