Press release,OIG Releases Report of FDA’s Oversight of Clinical Trials, Concludes Improvement of Information Systems and Processes is Needed, September 2007: “Weaknesses in the Food and Drug Administration’s (FDA) information systems and management processes hinder the agency’s ability to oversee clinical trial inspections. So concludes Inspector General Daniel R. Levinson of the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) in a report released today…To protect human subjects, federal law requires that all new drugs and medical devices undergo clinical trials to demonstrate their safety and efficacy prior to receiving FDA approval. FDA inspects clinical trials to determine whether sponsors, clinical investigators, and institutional review boards responsible for conducting or overseeing clinical trials for investigational products are complying with relevant regulations. FDA oversees clinical trials through a variety of mechanisms that include protocol reviews and onsite inspections through its Bioresearch Monitoring Program (BiMo). The OIG report focused exclusively on BiMo inspections, an important mechanism for protecting human subjects once a clinical trial is underway. OIG concluded that the FDA does not have a mechanism to identify all clinical trials and Institutional Review Boards (IRBs), which approve, monitor, and review research involving human subjects. Moreover, it lacks a comprehensive database for tracking its inspections of clinical trials. Previous OIG reports found similar weaknesses.”