483
Jerome Daniel, M.D.Jerome Daniel, M.D. – FDA 483, Apr 19, 2021
Record Details
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.
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ID · 5a70c410-e07d-4ef1-a5b3-86f866f71e4c
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