The principles of Risk-Based Quality Management (RBQM) and Risk-Based Monitoring (RBM) were introduced in the ICH E6 (R2) guidance several years ago and have been strongly encouraged by regulatory bodies since 2011. These methodologies call for a more targeted, risk-based approach to trial oversight, including less reliance on traditional on-site monitoring and greater reliance on remote and centralized monitoring to ensure patient safety and reliable data/outcomes. An increasing number of clinical research organizations have already been moving towards the new monitoring paradigm, but often with a cautious and stepwise approach especially with reductions in on-site monitoring. The current COVID-19 pandemic has necessitated a greater reliance on remote and centralized monitoring than ever before, given the restrictions that have been imposed on-site monitoring visits to clinics. Organizations that were slow to embrace RBQM are now racing to determine how best to oversee their studies without the benefit of on-site monitoring, and those already in various stages of adoption are rapidly adjusting their strategies to more completely remove their reliance on-site visits.

This webinar will explore lessons learned, challenges, and best practices for remote and centralized monitoring in the context of the "new normal" imposed on us during the current pandemic, as well as the longer-term implications for trial monitoring. A panel of experts representing the perspective of sites, sponsors, and regulators will discuss a number of questions including:

• What have we learned thus far regarding the move to remote and centralized monitoring?
• What challenges have been encountered, and what best practices have emerged?
• Should source data verification (SDV) and source data review (SDR) be conducted remotely?
• What is the investigative site's impact?
• What are regulators expecting with respect to the balance between on-site and remote/centralized monitoring?
• Are we able to ensure the same level of patient safety and data quality in this new paradigm?

Panelists:

• Steve Young, (Moderator) Chief Scientific Officer, CluePoints
• Jackie Gough, Director Centralized Monitoring and Data Surveillance, Astellas Pharma
• Alyson Karesh, Director, Division of Clinical Trial Quality, Office of Medical Policy, FDA
• Nick May, Senior Director Clinical Operations, Parexel
• Jean Mulinde, PhD, Division of Clinical Compliance Evaluation, CDER, FDA
• Nelson Rutrick, CEO, Adams Clinical