Reporting serious adverse events (created 2006-02-03).

The FDA held a meeting on March 21, 2005 soliciting opinions about how adverse events should be reported to Institutional Review Boards (IRBs).

Some of the testimony provided to FDA can be found on the FDA website and in various spots on the Internet, mostly in PDF format.

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 2008-11-26. 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.