Risk-based Monitoring (RBM) has caught the attention of industry and regulators alike. In March 2019, FDA released a new draft guidance titled “A Risk-Based Approach to Monitoring of Clinical Investigations – Questions and Answers” which is intended to help support the 2013 “Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring” (RBM) guidance. This new guidance shows the importance FDA places on work environments and personnel that perform with a risk-based mindset. To achieve this, your clinical operations must have the right personnel in the right positions, with the right training and support to do their jobs.
Educating and supporting current resources is a significant challenge for sponsors/CROs and investigation sites and has been a root cause of weak ineffective study start-up and issues management efforts. We see this in study and site selection efforts, training content, monitoring plan development, and more. This session will cover global risks, identify common gaps, and show you where to dig to find the solutions. Finally, you will be presented with tools to ensure your teams are equipped with the necessary skills to succeed in an effective RBM environment.
Attend this interactive session and you will be able to:
- Recognize the gaps in sites, sponsor/CRO quality systems to support the needed super team
- Discuss what supports the new needed skill set for improved study start-up
- Discover the needed skills sets that are not inherent and how to “train-up” to support successful teams