The U.S. Food and Drug Administration is interested in supporting demonstration projects to test using an end-to-end Electronic Health Record (EHR)-to-Electronic Data Capture (EDC) single-point data capture approach in clinical research environments.
Over the past decade, EDC systems have become ubiquitous for the capture of clinical trials data while EHRs have been widely adopted and are rapidly becoming a standard part of clinical care, states a June 26 Federal Register notice from FDA. The regulatory agency believes an end-to-end EHR-to-EDC single-point capture of source data could open up opportunities to improve clinical trial design and execution, speed the cycle of clinical research and get medicines to market faster.
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