Risk-based monitoring is the process of ensuring the quality of clinical trials by identifying, assessing, monitoring and mitigating the risks that could affect the quality or safety of a study. Guidance from the US FDA in 2013 outlines three steps in a risk-based approach to monitoring:
Identify critical data and processes. We can accurately monitor the quality of a study and the safety of its Participants. A sponsor must know which elements are most important for each particular study – from informed consent to eligibility screening and tracking of adverse events.
Perform a risk assessment. A risk assessment involves determining specific sources of risk and the effect of study errors on those risks.
Develop a monitoring plan. According to FDA's guidance, a monitoring plan should "describe the monitoring methods, responsibilities, and requirements of the trial." The plan is responsible for communicating risks and monitoring procedures to everyone involved in monitoring the trial.