2005N-0038 Reporting of Adverse Events to Institutional Review Boards; Public Hearing
FDA Comment Number : EC14
Submitter : Dr. Bryan Cowan Date & Time: 03/28/2005 03:03:20
Organization : University of Mississippi Medical Center
Category : State Government
Issue Areas/Comments
A simple comment: I receive some 2-15 AE forms each week. This number is probably high because I participate in three multicenter programs sponsored by pharmaceutical companies. In the last 2 years, none occured at our institution, and each requires a submission to our IRB. What is the purpose of this? I recommend that AE form be streamlined.