April 13, 2005 Dear Colleagues, Research protocols involving products that are under FDA jurisdiction (such as INDs or IDEs) are subject to an FDA inspection at any time. The FDA notifies the principal investigator when they wish to schedule an inspection. If you receive such notice, you must let the compliance group in the Office of Human Subjects Research (410-955-3008) know--we can help. A team from OHSR will meet with you to help prepare for the inspection.They will also attend the inspection to assist in answering any regulatory or institutional policy questions that may arise. Finally, OHSR staff will coordinate all responses to observations made at the inspection to protect both you and the institution. In doing so, we will make certain that we obtain input from the General Counsels' Offices. If you wish to learn more about your responsibilities as an investigator when doing FDA-regulated research, there are a number of resources: for general information about the FDA bioresearch monitoring program - http://www.fda.gov/cdrh/comp/bimogen.html; for information on FDA inspections of clinical investigations involving drugs, biologics, medical devices, and radiological products -http://www.fda.gov/oc/ohrt/irbs/operations.html#inspections;for device studies only-http://www.fda.gov/cdrh/devadvice/ide/enforcement.shtml#inspection_program. Again, please call on us for help BEFORE the FDA inspection. Thanks for your help in this important matter. Sincerely, Michael J. Klag, M.D., M.P.H.
Vice Dean for Clinical Investigation
David M. Levine Professor of Medicine | 
