domingo, 22 de mayo de 2016

Drug Information Update-Use of Electronic Health Record Data in Clinical Investigations

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The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.


On May 16, 2016, the Food and Drug Administration (FDA) issued a draft guidance for industry "Use of Electronic Health Record Data in Clinical Investigations."  The draft guidance is intended to assist sponsors, clinical investigators, contract research organizations, institutional review boards (IRBs), and other interested parties on the use of electronic health record (EHR) data in FDA-regulated clinical investigations. The guidance aims to facilitate use of electronic health record (EHR) data in clinical investigations and to promote the interoperability of EHRs and electronic systems supporting the clinical investigation.
Please see the Notice of Availability (NOA) for information on how to submit comments on the draft guidance.

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