Risk-Based Monitoring

What is Risk-Based Monitoring (RBM)?

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. To accurately monitor the quality of a study and the safety of its participants, the 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 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

DSG – Leading the way for a RBM approach to monitoring

RBM from DSG is part of its end-to-end eClinical software and data management services. DSG eCaseLink™ EDC and data-driven services build on the concept of RBM to enhance trial execution. Our combination of software and services enables better decision making, detailed insights, greater patient safety, better study quality, and efficiencies in trial management.

The results: Dramatic reduction in the need for source data validation (SDV) and significant cost savings that free precious resources for what really matters – drug or device approval. And DSG is with you every step of the way, whether in a full-service capacity or as a functional service provider (FSP).

Bottom line results, your study, your way.

We are always excited to see new applications complimenting EDC and direct data collections while dramatically reducing resources required to perform a clinical trial. Eliminating paper data review with eSource and now with risk-based monitoring are resource game changers for our industry.