FDA has issued final guidance, Guidance for Industry: Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring to assist sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational studies of medical products, including human drug and biological products, medical devices, and combinations. The overarching goal of the guidance is to enhance human subject protection and the quality of clinical-trial data by focusing sponsor oversight on the most important aspects of study conduct and reporting.
The guidance specifies that sponsors can use a variety of approaches to fulfill their responsibilities for monitoring clinical-investigator conduct and performance in investigational new drug studies conducted under 21CFR part 312 or investigational device exemption studies conducted under 21 CFR part 812. The guidance describes strategies for monitoring activities that reflect a modern, risk-based approach that focuses on critical study parameters and relies on a combination of monitoring activities to oversee a study effectively. For example, the guidance specifically encourages greater use of centralized monitoring methods where appropriate.
The guidance focuses principally on monitoring, which is one aspect of the processes and procedures needed to ensure clinical-trial quality and subject safety. Monitoring is a quality-control tool for determining whether study activities are being carried out as planned, so that deficiencies can be identified and corrected. The guidance specifies that monitoring, or oversight, alone cannot ensure quality and that quality is an overarching objective that must be built into the clinical-trial enterprise. FDA recommends a quality risk-management approach to clinical trials and is considering the need for additional guidance describing this approach.
The guidance was prepared by the Office of Medical Policy in the Center for Drug Evaluation and Research (CDER) in cooperation with CDER’s Office of Scientific Investigations in the Office of Compliance, the Center for Biologics Evaluation and Research (CBER)’s Office of Compliance and Biologics Quality, the Center for Devices and Radiological Health’s Office of Compliance, the Office of the Commissioner’s Office of Good Clinical Practice, and the Office of Regulatory Affairs.
FDA, Guidance for Industry: Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring (Rockville, MD, August 2013).