Ira L. Berger, M.D. – FDA EIR, Nov 13, 2020

An FDA comprehensive bioresearch monitoring inspection of Ira L. Berger, M.D., located in Rockville, MD, was conducted from November 9-13, 2020. This surveillance inspection, classified as high-priority by the Center for Biologics Evaluation and Research (CBER) under the Prescription Drug User Fee Act (PDUFA), focused on Dr. Berger’s role as Clinical Investigator for the Novavax SARS-CoV-2 vaccine study (Protocol #2019nCoV-101, IND #22430). The inspection adhered to FDA compliance program CP7348.811 for Clinical Investigators. Although no FDA-483 ‘Inspectional Observations’ were issued, several issues were identified and discussed with Dr. Berger and management. These included subject non-compliance, a COVID test sample traceability problem, non-adherence to Institutional Review Board (IRB) guidelines (specifically, failure to notify the IRB of a vaccination pause lift), and general good documentation practice concerns with a study log. Data discrepancies between source records and electronic case report forms were also noted. Furthermore, issues related to investigational product control and documentation were discussed, such as potential unblinding risks with biohazard waste disposal, inadequate documentation of product preparation, storage, and temperatures, and incomplete destruction records. The site was also reminded of its responsibility to ensure IRB notifications and approvals for study pauses and recommencements, even if submitted by the sponsor.