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#140: Unlocking the Future of Clinical Trials: How the ICH M11 Digital Protocol Template Enables Key Stakeholders
Monday June 16, 2025 3:45pm - 4:45pm EDT
151A
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-538-L04-P; CME 1.00; RN 1.00

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.

Chair

Ron Fitzmartin, PhD, MBA

Speaker

Digital Protocol Template: Industry Perspective
Vivian Combs, MS


Speakers
avatar for Vivian Combs

Vivian Combs

Director of Scientific Communications, Eli Lilly and Company, United States
Vivian Combs is a full-time Process Owner within Eli Lilly and Company's Clinical Trial Foundations organization, where she is focused on medical writing, content reuse, and automation. She recently completed her duties as the rapporteur for the ICH M11 CESHarP (Clinical Electronic... Read More →
avatar for Ron Fitzmartin

Ron Fitzmartin

Principal Consultant, Decision Analytics, United States
Ron Fitzmartin is a Principal Consultant at Decision Analytics. Previously, Ron was Senior Advisor in the Data Standards Branch, Office of Regulatory Operations, Center for Biologics Evaluation and Research, FDA. He provided policy and strategy consultation on electronic regulatory... Read More →
Monday June 16, 2025 3:45pm - 4:45pm EDT
151A Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session |   04: MedAffairs-SciComm, Session

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