NCI-EVS: Building the Semantic Infrastructure to Support CDISC Data Standards and Real-World Data

Abstract

Evolution and enrichment of CDISC terminologies are driven by the active interception of the research community’s semantic needs and by a robust development and publication process, managed jointly by NCI-EVS and CDISC. CDISC terminology integration within the rich semantic infrastructure of the NCIt provides additional benefits in knowledge representation as well as mapping to other reference sources and data standards, enabling semantic interoperability and data integration across multiple data standards and models. The technology, services, and processes that NCI-EVS employs to support CDISC have yielded a terminology set that is robust, fit for purpose, and concisely defined, allowing for efficient regulatory review of medical products. These same technologies, services, and processes will aid the current effort to expand the utility of CDISC standards for Real-World Data (RWD) analysis to better support the generation of Real-World Evidence (RWE).