Compliance News

The U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) will present a webinar on the draft guidance for industry, Use of an Electronic Informed Consent in Clinical Investigations: Questions and Answers, on Monday, 20 April 2015, from 1:00 p.m. – 2:00 p.m. EDT.

The guidance provides recommendations for clinical investigators, sponsors, and institutional review boards (IRBs) on the use of electronic media and processes to obtain informed consent for regulated clinical investigations.  A copy of the guidance may be found at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM436811.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

Access the Webinar on Monday, 20 April 2015, from 1:00pm - 2:00pm using the following link: https://collaboration.fda.gov/guidancewebinars/