StATS: Reporting of adverse events (created 2008-08-05).
Most Institutional Review Boards (IRBs) have difficulty coping with the volume of adverse events that study sponsors report to them. The FDA held a public meeting about this issue recently, and some written responses are available as PDF files at the following location:
This page was written by Steve Simon while working at Children's Mercy Hospital. Although I do not hold the copyright for this material, I am reproducing it here as a service, as it is no longer available on the Children's Mercy Hospital website. Need more information? I have a page with general help resources. You can also browse for pages similar to this one at Category: Adverse events in clinical trials.