FDA 483 - David M. Stoll, MD - May 09, 2011

An FDA inspection of David M. Stoll, M.D., a bioresearch clinical investigator in Santa Monica, CA, revealed significant deficiencies in the conduct of clinical investigations. Observations included failure to follow investigational plans, unauthorized changes to source records, inadequate IRB communication regarding protocol deviations and study termination, and issues with maintaining accurate case histories and informed consent documentation. These findings indicate a serious lack of oversight and adherence to regulatory requirements in clinical trial conduct.