In 1977, the U.S. Food and Drug Administration (FDA) established the Bioresearch Monitoring Program (BiMo) to develop cross-center guidelines for these inspections of clinical investigators, sponsors, and IRBs (hereinafter referred to as BiMo inspections). Introduction of the BiMo as an agency-wide initiative ensured the quality and integrity of data submitted to FDA and provided for the protection of human subjects in clinical trials by focusing on preclinical studies on animals, clinical investigations, and the work of institutional review boards.