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 webpage was originally published at the StATS website, which is currently unavailable. There is a dispute about the ownership of these pages, so I am only able to include a brief excerpt from this page.
This work is licensed under a
Creative
Commons Attribution 3.0 United States License. This page was written by
Steve Simon and was last modified on
2008-11-10. 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.