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FDA issues guidance on using EHR data in clinical investigations
Healthcare IT News: The U.S. Food and Drug Administration published guidance meant to give clarity to clinical investigators, research organizations, IRBs and others on the use of electronic health record data in FDA-regulated clinical investigations.
The draft gives FDA recommendations on: whether and how to use EHRs as a data source in clinical investigations; using EHRs that are interoperable with other electronic systems supporting clinical trials; ensuring the quality and the integrity of EHR data; and making sure electronic source data meets FDA requirement for record keeping and retention.
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