Automated Electronic Health Record to Electronic Data Capture Transfer in Clinical Studies in the German Health Care System: Feasibility Study and Gap Analysis.

This use case demonstrates that secure, consistent, and automated end-to-end data transmission from the treating physician to the regulatory authority is feasible. Automated data transmission can be expected to reduce effort and save resources and costs while ensuring high data quality. This may facilitate the conduct of studies for both study sites and sponsors, thereby accelerating the development of new drugs. Nevertheless, the industry-wide implementation of EHR2EDC requires policy decisions that set the framework for the use of research data based on routine PMS data.