October 24, 2005

Dear Colleagues:

The Office of Human Subjects Research compliance monitoring program began in June 2004. Over 50 IRB approved protocols have been reviewed by the compliance monitors since that time, and there are several trends that have surfaced during the visits. I am pleased to announce that an educational session has been developed to provide an overview by the compliance monitors of issues that occur during the conduct of an IRB approved research project. Tips on surviving a monitoring visit, either by the internal monitors or by an FDA inspector, will be provided. The one hour session will be held on Thursday, November 10, 2005, in the Broadway Research Building (BRB) Room G01, at 1:30 p.m. We look forward to seeing you on the 10th, as feedback from attendees will assist us in developing future information sessions.

Sincerely,
Daniel E. Ford, M.D., M.P.H.
Vice Dean for Clinical Investigation