On Monday, April 20, 2015, the Office of Medical Policy (OMP) in the Center for Drug Evaluation and Research (CDER), presented a webinar on the Draft Guidance: Use of an Electronic Informed Consent in Clinical Investigations Questions and Answers.
Summary: The Food and Drug Administration is announcing the availability of a draft guidance entitled “Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers.” The purpose of this guidance is to provide recommendations for clinical investigators, sponsors, and institutional review boards (IRBs) on the use of electronic media and processes to obtain informed consent for FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof.
Federal Register Publication Date: 03/09/2015
Comments Date: 05/08/2015
Docket Number: FDA-2015-05377
Leonard V. Sacks, M.D.
Associate Director for Clinical Methodology
Cheryl A. Grandinetti, Pharm.D.
Health Scientist Policy Analyst