FDA 483 - Richard Bernstein, MD, PhD - October 10, 2019

An FDA inspection of Richard Bernstein, MD, PhD, a clinical investigator in Chicago, IL, revealed significant deficiencies across two studies, RESPECT-ESUS and SOCRATES. Observations included widespread protocol deviations such as missing diagnostic evaluations, failure to re-image brains, incomplete screening procedures, and delayed reporting of adverse events. Additionally, the firm failed to obtain proper informed consent for sub-studies and did not implement revised consent forms, alongside maintaining inadequate and inaccurate case histories, including lost study records.