Deconstruction of data and standards to support harmonization and interoperability with real world data for clinical research and regulatory submissions. (U01 Clinical Trial Not Allowed)

Data concepts (not just the information but the underlying definition of its meaning) between many different sources of real-world data (RWD) (e.g., EHRs, Claims, and digital health technologies) as well as those used in clinical research and regulatory submissions are almost always similar but not identical. This difference requires mapping and transforming data between RWD and clinical research use to rely heavily on human interpretation and is an obstacle to developing a fully reliable computer-driven approach. This request for applications is aimed at defining the elemental components of RWD in a way that may support future computable approaches to defining what is currently only implied by definitions of data elements or business practices to facilitate standardization for regulatory submissions.