Measuring Expressiveness of the Clincal Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model...

The United States (US) 21st Century Cures Act of 2016 was developed to accelerate development of new therapeutics. The use of real-world data (RWD) in regulatory submissions for therapeutic development in the US is increasingly supported by US Food and Drug Administration (FDA) guidance. Registries are a recognized source of RWD for regulatory submissions to the FDA. Drug and Biologics submissions to the FDA must use the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) format. However, designed for clinical trials, the ability of SDTM to represent RWD, including data from registries has been questioned. To evaluate the expressiveness of SDTM for registry data, the American Burn Association, Burn Care Quality Program (BCQP) Registry v4.1 as an exemplar was systematically mapped to the CDISC SDTM v3.3 standard. All BCQP Registry data elements were representable in the SDTM with 93% mapping to standard SDTM domains, and the remaining 7% mapped to SDTM Supplemental Qualifiers.