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Bethesda North Marriott Hotel and Conference Center

Feb 12, 2024 8:00 AM - Feb 14, 2024 2:30 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Don't miss the latest trends, innovations, and best practices in regulatory submissions, information, and document management (RSIDM)!

Session 3: FDA Plenary: ICH M11 Protocol Template: A Global Solution for Global Drug Development

Session Chair(s)

Ron  Fitzmartin, PhD, MBA

Ron Fitzmartin, PhD, MBA

Senior Informatics Advisor, Office of Regulatory Operations, CBER

FDA, United States

The pandemic has taught us that clinical trials need to happen quickly and involve many regulators, pharma companies, investigators and clinical sites all over the world. One common necessary tool to conduct a trial is the clinical protocol. The protocol is a document that provides the roadmap how the trial will be conducted (the purpose, objectives, endpoints, estimands, methodology, and statistical considerations). For decades we have had a harmonized the electronic common technical document format for submission of marketing application, as well as a format and content for clinical study report. However, we have not, until now, had a globally harmonized clinical protocol. The lack of a common protocol template for global clinical trials contributes to inefficiencies and difficulties in the conduct of the study, as well as in the regulatory review, and assessment of the protocol content. The use of an electronic protocol that is standardized in its structure will improve access to consistent and searchable information (e.g., schedule of assessments, objectives, adverse event information) across sponsors, regulators and clinical sites.

This session will provide an overview and the latest developments of the ICH M11 Clinical Protocol Template: 1) Guideline, 2) Protocol template, and 3) Technical specification and how these documents will facilitate more efficient and effective conduct of global trials for global drug development.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Describe the M11 ICH deliverables and the latest developments on ICH M11 guideline, protocol template and technical specification
  • Describe the types of trials and phase that the template encompasses
  • Understand the technical specification as a technical represenation of the template to facilitate electronic exchange


Y. Veronica  Pei, MD, MEd, MPH


Y. Veronica Pei, MD, MEd, MPH

FDA, United States

Acting Associate Director, Biomedical Informatics and Regulatory Review Science

Vada A. Perkins, DrSc, MSc


Vada A. Perkins, DrSc, MSc

Boehringer Ingelheim, United States

Vice President, Global Head of Regulatory Intelligence & Policy

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