ICH E6 (R3) Essentials for CRAs: What You Need to Know
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This practical and interactive webinar is designed to help Clinical Research Associates (CRAs) understand what the updated ICH E6(R3) Good Clinical Practice Guideline means for their day-to-day work.
It focuses on the evolving expectations of CRAs in supporting compliance, quality oversight, and site engagement, while aligning with the principles of critical thinking, proportionality, and risk-based approaches.
Through real-world examples and discussion, participants will strengthen their ability to monitor effectively and add value in a changing regulatory landscape.
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Understand the intent and structure of the ICH E6(R3) GCP Guideline
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Recognise key updates and how they affect the CRA role
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Apply critical thinking and prioritisation during monitoring
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Strengthen site oversight and support investigator responsibilities
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Promote quality by design and ongoing improvement in monitoring
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Identify monitoring approaches to mitigate common site-level risks
- Maria VelevaClinical Research Quality Expert | Consultant |
MD, MRQA- Member of the Research Quality Association (RQA), European Forum for Good Clinical Practice (EFGCP), and Bulgarian Association of Clinical Research (BACR).
- Chair of the RQA Consultants Group and member of the EFGCP Quality Working Group.
- Over 20 years of experience in clinical research, including team management, project leadership, quality assurance, global audit delivery, and support for regulatory authority inspections.
- Introduction to ICH E6(R3): why it matters for CRAs
- The CRA’s evolving role in the era of R3
- Risk-based monitoring, critical thinking, and documentation
- Supporting site compliance with informed consent, protocol adherence,
and delegation - Monitoring for quality: oversight of third parties and essential
processes - Common challenges and what "fit-for-purpose" monitoring looks like
- Building strong site relationships and fostering a culture of quality
Join the expert discussion