FDA EIR - Brian I Rini MD - January 25, 2019

An FDA inspection of Brian I Rini MD in Cleveland, OH, was conducted from January 14-25, 2019, to assess clinical research practices for a specific protocol. The inspection was performed under Compliance Program 7348.811, governing clinical investigators, referencing the Federal Food, Drug, and Cosmetic Act, specifically 21 CFR 312.64(b) and 21 CFR 312.60.

The inspection resulted in an FDA-483, Inspectional Observations, citing two primary issues. First, the site failed to promptly report a serious adverse event (gastrointestinal hemorrhage) to the sponsor, with a delay of 20 days. Second, numerous non-serious adverse events for four of eight study subjects, including diarrhea, fever, nausea, elevated lab levels, and pancreatitis, were not reported as per protocol. Additionally, concomitant medications for two subjects were not documented as required.

Beyond formal observations, the inspector noted concerns regarding incomplete source documentation for blood pressure records, improper use of white-out in medical records and delegation logs, and a sub-investigator signing a study drug order without proper training or being listed on the delegation log.

In response, Dr. Rini committed to submitting a written reply to the district within 15 business days for the FDA-483 observations. The site also initiated voluntary corrections by entering previously unreported adverse events and concomitant medications into the electronic case report forms. Management further agreed to address the discussion items by improving source documentation, prohibiting white-out use, and developing corrective actions for staff training and authorization protocols.