Use of Electronic Health Record Data in Clinical Investigations – Dec. 6, 2018

FDA discusses recommendations on the use of electronic heath record (EHR) data in FDA-regulated clinical investigations. The recommendations aim to modernize and streamline clinical investigations and promote the interoperability of EHR and EDC systems.
FDA CDER speakers include Leonard Sacks, MD; Mitra Rocca, Dipl. Inform. Med.; and Cheryl Grandinetti, PharmD.

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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

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