FDA EIR - Han C. Phan, MD, Clinical Investigator - April 05, 2024

An FDA surveillance inspection was conducted at Han C. Phan, MD, a clinical investigator, from April 1 to April 5, 2024. The inspection, carried out under regulatory framework CP 7348.811 for Clinical Investigators, revealed several significant deficiencies concerning an ongoing drug study, resulting in the issuance of an FDA Form 483.

The main violation cited was the failure to retain source records. Further issues included multiple discrepancies found between assessment records (COAs) and background materials, and a lack of proper record retention for off-site paper questionnaires. It was also identified that raters responsible for primary efficacy endpoint assessments consistently failed to adhere to established scoring rules, with initial inadequate corrective actions. Additionally, some paper screening questionnaires lacked assessor identification and contained entries made in pencil, impacting data integrity and traceability.

Dr. Phan acknowledged these findings and committed to acquiring missing records, requesting certified electronic records and audit trails from the sponsor, and ensuring proper attribution for all documentation. She is required to submit a written response to the FDA Form 483 within 15 business days, detailing her corrective and preventive actions to address the identified issues and ensure compliance with her regulatory responsibilities.