The National Cancer Institute's Enterprise Vocabulary Services (NCI-EVS) helps CDISC develop, maintain, and publish Controlled Terminology (CT) for the SDTM, CDASH, ADaM, and SEND data standards. CDISC Controlled Terminology is maintained within the NCI-EVS NCI Thesaurus (NCIt) and is available for download here. EVS Terminologists assist the project teams with the development of controlled terminology.
Once the list of concepts has been identified, the Terminology Expert performs an initial gap analysis against CDISC CT to identify concepts that exist in CDISC standards. For each mapped concept, the Terminology Expert inputs the code list name, code list NCIt c-code reference, CDISC submission value, and submission value NCIt c-code reference onto the concept listing spreadsheet. Additionally, the Terminology Expert provides descriptions for each concept. If existing CDISC definitions are published or are currently in draft form, those definitions are used. In cases where gaps exist in CDISC CT, the Terminology Expert provides NCIt definitions as draft. The Terminology Expert also provides comments on concepts to include where a term may be mapped within the CDISC model, issues regarding term granularity, valid value sets, etc. It is assumed that these definitions are to be used for informational purposes only, as required by the Modeling Team. Eventually, the concepts and valid value sets will be developed and definitions standardized by the CDISC Controlled Terminology Team.
- See the Gap Analysis Template.