The FDA is seeking feedback from stakeholders on the challenges, barriers and enablers that might be impacting the adoption of RBM and related opportunities to improve RBM implementation.
This public workshop – “Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations”, held under a cooperative agreement with the U.S. Food and Drug Administration, is an opportunity to capture stakeholder input on:
- The extent to which organizations have implemented risk-based assessment and monitoring, including in conjunction central monitoring approaches
- Lessons learned from strategies employed to overcome any obstacles to implementation and to continued execution of RBM
- Enablers that support implementation and execution of risk-based monitoring
- How stakeholders assess impact of their RBM program
- Remaining challenges to implementation or execution that need to be addressed
The workshop is being held in Washington DC on July 17. Linda Sullivan, Executive Director WCG-Metrics Champion Consortium, will participate in two sessions:
- Session 5: Measuring the Impact of Risk-Based Monitoring Approaches
- Session 6: Synthesis and Next Steps
Visit the MCC Events page for additional information.