After reviewing warning letters issued to investigators and sponsor-investigators last year, through FDA’s Bioresearch Monitoring Inspection Program, IMARC’s clinical monitoring team has assembled the 2011 “TOP 10” list. This list is not intended to point fingers at investigators, but rather, to document the non-compliance trends in an effort to raise industry awareness of improvement needed. Whether you are a sponsor, a monitor, or an investigative site, everyone has a stake in the outcome of an FDA BIMO inspection.