FDA EIR - Princeton Biomedical Research - May 03, 2000

An FDA inspection of Princeton Biomedical Research, P.A., under Principal Investigator Dr. Jeffrey T. Apter, M.D., was conducted from April 11 to May 3, 2000. This for-cause inspection revealed significant non-compliance with clinical trial protocols and regulatory expectations across two studies. Key violations included research subjects being screened and diagnosed before providing informed consent. Diagnoses were often made by non-physician raters, and physician sign-offs did not consistently reflect actual visit dates or physician presence. Physical examinations were conducted by a Physician's Assistant without obtaining prior sponsor approval.

Research source documentation was inadequate, characterized by altered or uncurrent dates, and lacked consistent evidence of Principal Investigator or Co-Investigator oversight. Enrollment eligibility test scores were changed without justification, and adverse event reporting was deficient, failing to consistently include causal relationship ratings by a medical doctor. Furthermore, the firm lacked source documentation to verify if potential subjects were screened for prior investigational drug treatments.

An FDA-483 was issued detailing these observations. In response, Dr. Apter acknowledged some issues, and corrective actions included revising follow-up assessment forms to ensure proper documentation of physician and staff signatures and dates. The firm was reminded of its obligation to ensure Institutional Review Board (IRB) compliance regarding knowledgeable members and to obtain written sponsor approvals for any protocol deviations.