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Session 10 Track 4: TransCelerate, FDA, and NIH: The Evolution of a Common Protocol Template
Session Chair(s)
Stacy Tegan
Program Director
Transcelerate Biopharma, Inc., United States
The TransCelerate Common Protocol Template and the NIH-FDA Protocol Template are tools available to facilitate authoring of streamlined, harmonized protocols. Learn about the collaboration between these organizations. Hear from an FDA reviewer on the protocol review process and why this harmonization is critical to regulators. This session will include a demonstration of the electronic protocol tool which enables content reuse.
Learning Objective : At the conclusion of this session, participants should be able to:- Discuss the drivers behind the collaboration NIH-FDA and TransCelerate to achieve harmonized protocol structure
- Select the protocol template best suited to their needs
- Explain critical FDA reviewer needs related to protocol and study data 4 and articulate the potential future gains of a digital protocol template
Speaker(s)
An FDA Reviewer’s Perspective on the Common Protocol Template
Eileen E. Navarro Almario, MD, MS, FACP
FDA, United States
Lead Physician
Collaboration between NIH, FDA, and TransCelerate to Create Harmonized Protocol Templates
Cynthia Boucher, MS
National Institutes of Health (NIH), United States
Clinical Trials Specialist
TransCelerate’s Technology Enabled Common Protocol Template
Mitzi Allred, PhD
Merck & Co., Inc, United States
Director, Clinical Operations
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