FDA 483 - Princeton Biomedical Research - September 24, 1997

An FDA inspection of Princeton Biomedical Research (PBR), led by Dr. Jeffrey T. Apter, was conducted from September 10-24, 1997, focusing on their role as a Principal Investigator site for a clinical study (Protocol "Double-Blind, Fixed-Dose Multicenter Study Of ███████████████ VS Placebo in Outpatients With Moderate To Severe Depression"). The inspection identified several critical observations. PBR failed to promptly report a serious adverse event for study subject #01109 to the Institutional Review Board (IRB) for approximately 105 days, and another adverse event (severe impotence) was not recorded on the sponsor's case report form. Additionally, five out of twelve reviewed study subject records showed deviations from the protocol, such as improperly recorded blood pressure, exceeding the specified double-blind period, and missing vital signs. Furthermore, two physicians who performed study evaluations for subject #01122 were not listed on the FDA Form 1572 as subinvestigators, a regulatory requirement for qualified personnel. Additional concerns included missing or incomplete Informed Consent Forms for several subjects and the practice of the sponsor retaining original ECG data instead of copies, compromising source data integrity. These findings indicate non-compliance with Good Clinical Practice and FDA regulations for clinical investigations. Princeton Biomedical Research committed to providing a written response to the FDA-483 observations and implementing corrective actions, including prompt amendments to the FDA 1572 and improved documentation practices.