On Monday, April 20, 2015, from 1:00 p.m. – 2:00 p.m. EDT, the Office of Medical Policy (OMP) in FDA’s Center for Drug Evaluation and Research (CDER) will present a webinar on the draft guidance for industry, Use of an Electronic Informed Consent in Clinical Investigations: Questions and Answers.
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.
Documents:
Date of Federal Register Publication: 03/09/2015
Date Comment Period Closes: 05/08/2015
Docket Number: Docket No. FDA- 2015-05377
Webinar Speakers:
Leonard V. Sacks, M.D.
Associate Director for Clinical Methodology
OMP/CDER/FDA
Cheryl A. Grandinetti, Pharm.D.
Health Scientist Policy Analyst
OMP/CDER/FDA
Webinar Online-Access Instructions: To access this webinar, follow the link provided below. Audio will broadcast from your computer speakers.
Webinar access link: https://collaboration.fda.gov/guidancewebinars/
After following the link, enter as a guest and provide your FULL NAME and organization (i.e. "John Smith - FDA/CBER"). The host will then allow you to enter. Closed captioning will be provided.
Questions/Comments can be submitted live via a Q/A chat window.
