Talk Study & Site Management track
The ABCs of Risk-Based Monitoring for Sites
Sat, Apr 26, 2025 · 4:30–5:30 PM CDT Hyatt Regency New Orleans
About this session
For more than a decade, multiple sources of regulatory guidance have increased their focus on risk management in clinical studies, paving the way for industry to adopt more risk-based monitoring strategies internationally. With the issuance of ICH E6(R3), an even more focused risk-based approach is expected. While Industry initially struggled to implement risk-based monitoring, moving review into central/remote scenarios as opposed to traditional onsite monitoring, we can now apply lessons learned to various indications and phases of research. We’ve come very far in tailoring systems and approaches to fit the needs of studies while still building in quality by design. Sites are important partners, but have been left out of the conversation about risk-based monitoring. Industry has fallen short in making risk-based monitoring something tangible to sites. Our goal is to bring sites a greater understanding of what sponsors/contract research organizations (CROs) are looking for, how they develop their key risk indicators, and how their ongoing monitoring and mitigation strategies impact their studies.
CEU: 1.00 ACRP
Speakers
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Associate Director, Clinical Operations - Quality Management · Innovaderm
Speaker
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Associate Director, Clinical Trial Management · Innovaderm
Speaker