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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)
Eileen E. Navarro Almario, MD, MS, FACP
Lead Physician, FDA, United States
An FDA Reviewer’s Perspective on the Common Protocol Template
Cynthia Boucher, MS
Clinical Trials Specialist, National Institutes of Health (NIH), United States
Collaboration between NIH, FDA, and TransCelerate to Create Harmonized Protocol Templates
Mitzi Allred, PHD
Director, Clinical Operations, United States
TransCelerate’s Technology Enabled Common Protocol Template