FDA 483 - James L. Bicksel MD - October 08, 2020

James L. Bicksel MD, a clinical investigator in Fairfax, VA, was cited for significant deficiencies in conducting clinical investigations. Observations included failing to follow the investigational plan by enrolling an excluded subject and missing required MRI scans, inadequate investigational drug disposition records, and a failure to maintain accurate and complete case histories, including informed consent forms and follow-up documentation for adverse events. These issues indicate a serious lack of adherence to clinical trial protocols and record-keeping standards.