Our popular Top 10 list of FDA warning letter findings is back! To assemble the list, IMARC’s clinical monitoring team reviewed warning letters issued by investigators and sponsor-investigators last year through FDA’s Bioresearch Monitoring Inspection Program. This list of warning letter findings 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.
To read the full, original article click on this link: Top 10 FDA warning letter findings for clinical investigators in 2011
