A02 - Knock, Knock, FDA Is Here: What You Need to Know for Bioresearch Monitoring (BIMO) Inspections of IRBs, Clinical Investigators, and Sponsor Investigators

FDA’s BIMO program is designed to protect the rights, safety, and welfare of subjects. It also verifies the accuracy and reliability of clinical study data submitted to the agency in support of new product approvals and assesses compliance with FDA regulations. This session will provide an overview of the FDA Office of Regulatory Affairs (ORA) and Center for Drug Evaluation and Research BIMO inspection process from initial notification through to post site visit, and how to respond to an FDA Form 483. In addition, speakers will review past and present inspection metrics highlighting common deficiencies identified during IRB and clinical investigator inspections and the inspection classification outcomes. Speakers will also discuss the relevant FDA compliance program and guidance documents stakeholders should be aware of for an FDA inspection.