FDA Issues Final Guidance for Industry: Use of Electronic Health Record Data in Clinical Investigations - Drug Information Update

Today the FDA published a guidance for industry entitled “Use of Electronic Health Record Data in Clinical Investigations; Guidance for Industry.” The guidance provides recommendations for sponsors, clinical investigators, contract research organizations (CROs), institutional review boards (IRBs), and other interested parties on the use of electronic health record (EHR) data in FDA-regulated clinical investigations. The guidance finalizes the draft guidance issued in May 2016.  This guidance is intended to assist sponsors, clinical investigators, contract research organizations, institutional review boards, and other interested parties on the use of electronic health record data in FDA-regulated clinical investigations.  The guidance’s goals are to modernize and streamline clinical investigations through inclusion of real world data in clinical investigations and facilitate integration of clinical trials that occur in routine care settings. In addition, we hope that the guidance will encourage sponsors and health care organizations to work with EHR and electronic data capture (EDC) system vendors to further advance the interoperability and integration of EHR and EDC systems.