FDA 483 - Jerome Daniel, M.D. - April 19, 2021

Jerome Daniel, M.D., a clinical investigator in Richmond, VA, was cited for failing to maintain adequate and accurate case histories during an inspection from April 12-19, 2021. The firm did not report several adverse events and numerous concomitant or prohibited medications for multiple subjects to the sponsor of the VERTIS CV Study. This indicates significant deficiencies in data reporting and adherence to clinical trial protocols.