FDA 483 - Francisco J. Ricart, M.D. - July 16, 2024

Ccm Clinical Research Group in Miami, FL, a clinical investigator, was cited for significant data integrity issues during an FDA inspection. The firm failed to maintain accurate case histories, with vital sign data for numerous subjects being inaccurately entered into the electronic case report forms. Additionally, the investigation was not conducted according to the protocol, as data was not entered in real-time and original paper source data was not uploaded as required.