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.
According to FDA, the use of a standards-based technology solution in clinical trials has the potential to: eliminate duplication of data by capturing and transmitting electronic source data, auto-populate the electronic study forms from EHRs, reduce transcription errors and improve the quality of data, and encourage entering source data at the point of care, among other benefits.
A demonstration project should ideally test the use of a standards-based technology solution to enable the collection of related healthcare and clinical research information within a single system and workflow, states the notice. Stakeholders may include regulated industry, EHR and EDC vendors, academic medical centers, and other interested parties.
The FDAs Center for Drug Evaluation and Research is accepting either electric or written requests for participation in demonstration projects until August 10. Projects are expected to last about 12 months but may be extended as needed.
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