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Unlocking the Future of Clinical Trials: How the ICH M11 Digital Protocol Template Enables Key Stakeholders
Session Chair(s)
Representative Invited
FDA, United States
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 Objective : Understand the ICH M11’s Role in Digital Protocols Across Stakeholder Roles; Explore Customization and Multi-View Capabilities; Evaluate the Impact on Decision-Making and Efficiency for Key Roles; Examine Multi-Format Exchange of Protocol Information.
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