Risk Based Monitoring

Rationale

The Risk Based Monitoring (RBM) Initiative was established in 2012 as one of TransCelerate’s five initial projects designed to create efficient and effective solutions in the R&D industry. Clinical trial sites have varying levels of experience and quality, but conventional monitoring approaches were not designed to manage potential differences. Although regulators were urging companies to move to a risk-based approach, no well-understood methodologies existed that would have enabled organizations to successfully deploy and scale risk-based monitoring.

To enable the industry to follow the regulators’ general guidance, TransCelerate has developed model guidelines for targeted, risk-based clinical trial monitoring, ultimately aiming to improve data quality and patient safety. TransCelerate’s Risk Based Monitoring methodology can be adopted by any size organization, and adapted to any type or phase of a clinical trial.

Impact

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

Benefits

Available Solutions