The session explores the transformative impact of the ICH M11 digital protocol template on key clinical trial stakeholders, such as medical writers, standards professionals, and regulatory reviewers. It highlights how standardized, structured content
Learning Objectives
Recognize the ICH M11’s Role in Digital Protocols Across Stakeholder Roles; Explain Customization and Multi-View Capabilities; Discuss how to evaluate the Impact on Decision-Making and Efficiency for Key Roles; Describe ways to examine Multi-Format Exchange of Protocol Information.
Monday June 16, 2025 3:45pm - 4:45pm EDT TBDWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
