Risk-Based Monitoring

DSG Risk-based monitoring

How we mitigate the risks that could affect the quality or safety of a study.

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.

Why RBM?

Compared to earlier clinical trial monitoring methods, like 100% source data verification (“SDV”), RBM can lead to increases in quality data, patient safety and efficiency. Specifically, it can enable:

  • Earlier detection of issues, with a greater focus on resolution and prevention of issue recurrence
  • Reduction in efforts expended on low-value activities through centralization and data analysis
  • Cost reductions through more focused centralized monitoring activities and targeted onsite monitoring
  • Greater compliance with Good Clinical Practice (GCP) and relevant regulatory requirements
  • A more collaborative cross functional team approach – the coordination of monitors, data managers, statisticians, medical monitors, and site staff