Use Of Electronic Health Record Data In Clinical Investigations

Use Of Electronic Health Record Data In Clinical Investigations

Use of Electronic Health Record Data in Clinical Investigations

On May 16, 2016, the Food and Drug Administration (FDA) issued a draft guidance for industry "Use of Electronic Health Record Data in Clinical Investigations." The draft guidance is intended to assist sponsors, clinical investigators, contract research organizations, institutional review boards (IRBs), and other interested parties on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. Ref. Source 7q.