FDA seeks to conduct demo project on EHR-data capture systems

The U.S. Food and Drug Administration is seeking to conduct demonstration projects testing the capability and performance of a single-point data capture approach between EHRs and electronic data capture systems, according to a notice published in the June 26 Federal Register.

According to the notice, 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;
• encourage entering source data at the point of care;
• facilitate remote monitoring of data to reduce the number of onsite visits by regulated biopharmaceutical industry;
• improve site monitoring to minimize the need for cross-reference data in multiple sources;
• make it easier for investigators to conduct clinical research;
• facilitate the inspection and reconstruction of clinical investigations by FDA; and
• improve the standards-based technology solution to encourage widespread adoption.

The FDA's proposed demonstration projects would assess and report the value and challenges of an EHR-to-EDC single-point capture of source data.

The FDA seeks comments and request for participation in the demonstration project.