FDA EIR - Steven J. Glass, M.D. - July 21, 2008

An FDA inspection conducted at Steven Glass, M.D., in Clementon, NJ, from July 7 to July 21, 2008, identified several significant observations regarding the conduct of a clinical investigation. The inspection, documented in an FDA Form 483, highlighted issues primarily related to adherence to the study protocol and the integrity of study data. Key findings included multiple protocol deviations, such as screening periods exceeding stipulated durations for certain subjects and the failure to complete required assessments, like injection site pain evaluations. Furthermore, several subjects signed incorrect versions of consent forms or experienced delays in signing required consent addendums, indicating deficiencies in informed consent procedures. Significant discrepancies were also observed between source documents, electronic Case Report Forms (eCRFs), and data listings. These inconsistencies affected critical data points such as PANSS scores, adverse event details (including start/end dates, relatedness to study drug, and intensity), and the accurate recording of concomitant medications. Such issues raise concerns about the reliability and accuracy of the collected study data. The observations underscore the need for strict compliance with established protocols and regulations governing clinical research, ensuring subject safety and data quality. The facility is expected to address these findings thoroughly to correct deficiencies and prevent recurrence.