The Association of Clinical Research Professionals
eResearch in Practice: Managing Clinical Trials with ICH E6(R3) Guidance
As clinical trials embrace a fully digital future, professionals across the research enterprise are adapting to new technologies, workflows, and global standards.
With the release of ICH E6(R3), expectations around quality, flexibility, and data integrity have evolved—placing greater emphasis on risk-based approaches, patient-centricity, and digital enablement.
This timely training explores how clinical research professionals can manage electronic systems, remote data capture, and decentralized models while staying compliant with U.S. and EU regulations. Featuring practical strategies, updated compliance checklists, and curated resources, this session empowers teams to confidently navigate today’s tech-enabled trial environment and prepare for what’s next.
You’ll gain confidence in navigating electronic systems, understanding stakeholder responsibilities, and applying key principles of quality and data governance. While this training equips you for real-world application, it also lays the foundation for deeper exploration into digital trial oversight and evolving compliance standards.
At the end of this course, participants should be able to:
Describe the key updates in ICH E6(R3) related to digital trial management, including stakeholder responsibilities and data governance principles.
Apply risk-based quality management strategies to the selection and oversight of electronic systems used in clinical trials.
Evaluate the compliance and effectiveness of electronic tools in supporting ethical, regulatory, and operational requirements in clinical research.