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Talk to a SpecialistTalk to a SpecialistDr. Han C. Phan, a clinical investigator, failed to conduct a clinical drug investigation in accordance with the investigational plan and applicable FDA regulations (21 CFR 312.60) during an inspection of his Atlanta clinical site in April 2024. Specifically, Dr. Phan did not properly administer and evaluate required clinical outcome assessments (COAs) as specified in the study protocol, including clinician-reported testing for enrolled subjects. The violations were identified through FDA's Bioresearch Monitoring Program, which inspects clinical research sites to ensure human subject protections and study compliance.