FDA EIR - Harry Erba, MD - April 13, 2021

An FDA for-cause inspection of clinical investigator Harry Erba, MD, at Duke Cancer Center in Durham, NC, took place from April 7 to April 13, 2021. The inspection, requested by the Center for Drug Evaluation and Research, followed the regulatory framework of the Food Drug and Cosmetic Act, specifically focusing on clinical investigators and sponsor-investigators. The review covered various aspects of two clinical trial protocols, including IRB approvals, subject records, and investigational product accountability. Notably, the inspection concluded without the issuance of an FDA Form 483, indicating that no official violations were observed, and prior complaints could not be verified. The primary issue discussed was a verbal observation regarding the documentation of principal investigator or sub-investigator assessment of adverse events for causal relationship. While study nurses documented these events, the electronic medical record system lacked clear evidence of the required review and sign-off by an investigator. Management confirmed the investigator's practice of reviewing adverse events and described a new procedure being implemented to ensure proper documentation of these assessments. Dr. Erba was reminded of his ongoing responsibilities to comply with the Food Drug and Cosmetic Act.