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Performing Root Cause Analysis in Risk-based Monitoring

Speaker: Sandra “SAM” Sather

Risk assessment and risk management are the two important aspects of risk-based monitoring. Effective risk action planning involves effective root cause analysis (RCA) as part of risk mitigation. Therefore, it is necessary to identify thoroughly root causes and sources of all potential risks, as well as root causes of failed risk mitigation to improve action planning. Effective RCA helps to build a robust action plan for mitigation of risks. This session includes more than the tools common to RCA, but also the scientific concepts of root cause analysis applied directly to clinical quality risk management practices with an outcome of tools specific for application in risk-based monitoring.

Key topics

  • How to integrate root cause analysis to risk-based monitoring
  • How to implement RCA processes that work with sponsors, sites and CROs
  • Interventions based on RCA, for risk diagnostic process, action planning and revisions
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