ABSTRACT
The Bioresearch Monitoring Program was established in 1977, and its activities include inspections of clinical investigators, sponsors, biopharmaceutical laboratories, IRBs, and toxicology laboratories. The FDA's routine surveillance inspections occur at randomly selected sites as part of this program and are called study-oriented inspections. Additionally, the FDA routinely audits selected sites that have participated in a pivotal trial (one that is essential to the success of an Investigational New Drug [IND] submission).
