Risk-based monitoring

A mix of centralized monitoring and on-site monitoring practices that focus on preventing or mitigating important and likely sources of error in the conduct, collection, and reporting of critical data and processes necessary for human subject protection and trial integrity. Sponsors should prospectively identify critical data and processes, then perform a risk assessment to identify and understand the risks that could affect the collection of critical data or the performance of critical processes, and then develop a monitoring plan that focuses on the important and likely risks to critical data and processes. FDA: Guidance for Industry, Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring