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.
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.
New requests or changes to existing Terminology can be accessed through the CDISC New Term Request Page.
Controlled Terminology Release
As of 31 Mar 2023 the ADaM, 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 2023-03-31. These terminology files replace all older ADaM, DDF, Protocol Entities, SDTM, and SEND terminology files and include terms from Review Package 53. There are approximately 105 new QRS terms and 586 new terms across ADaM, DDF, Protocol Entities, SDTM, and SEND terminology files. Additionally there are:
- Update to 10 published Codetable Mapping file: DD, DS, GI, IG, IS, MK, RP, SC, TS, and UR
- New Codetable mapping File: RE
- Update to Unit-UCUM Codetable Mapping file
- Update to Controlled Terminology Requests Denied file
- Update to CDISC Terminology Publication Schedule
- Update to the SDTM, SEND, ADaM Paired Codelists files
For SDTM Terminology publication on 2023-03-31, an Excel formatting issue caused unintended changes to a small subset of CDISC submission values that contain numbers across the following codelists: C182487, C189266, C160924, and C160923. The other file formats (.txt, .html, .pdf, .odm-XML, and .OWL/RDF) were not affected. NCI-EVS has re-issued the affected file (SDTM Terminology.xls, version 2023-03-31) on the NCI Ftp on 2023-04-04. We are sorry for any inconvenience this may have caused.