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

Speaker:

• Sara Croteau, Associate Director, Clinical Operations - Quality Management, Innovaderm

• Valerie Paolella, Associate Director, Clinical Trial Management, Innovaderm

Watch a Sneak Peek into the Session Content:

Related Resource:

The new ACRP Guidelines and Regulations Resource Center has the most relevant and up-to-date resources for all professionals whose roles involve conducting and leading clinical research. ACRP will post updates and links to content impacted by the changes to the ICH E6(R3) Good Clinical Practice Guidelines.