The agency filed a notice in the Federal Register last Friday.
According to the notice, the demonstration project would test the use of standards-based technology to foster the collection of healthcare and clinical research information within one system and workflow.
The need for single-point data capture has newly emerged following the growth of disparate health information systems, according to the notice.
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. To learn more, click here.
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