Webinar: Risk-Based Monitoring and The IRB: Convergence and Opportunities

Effective risk governance comprises both risk assessment and risk management. Risk-Based Monitoring (RBM) is an example of real-time data collection and analytics supporting an important, structured approach to clinical trial risk management. Risk governance has long been within the purview of ERBs, whose primary review tasks include risk-benefit assessment and evaluation of risk management processes. RBM is a component of risk governance, and its structure is surprising similar to the systematic evaluations of ERBs.

Clinical operation teams and ERB oversight can benefit from this natural alignment to improve effectiveness of trial monitoring and oversight. Risk governance requires the collaboration and coordination of all concerned with the collection, analysis and communication of all relevant risk information, including the ERB. The opportunities for improvement introduced by RBM invite evaluation of a new pattern of interaction between clinical development teams and ERBs. The speakers will examine these opportunities and provide recommendations to industry, ERBs and other stakeholders.

Learn more or register for Risk-Based Monitoring and The IRB: Convergence and Opportunities