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Bethesda North Marriott Hotel and Conference Center

Feb 05, 2018 7:00 AM - Feb 07, 2018 3:00 PM

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

Regulatory Submissions, Information, and Document Management Forum

Session 10 Track 4: TransCelerate, FDA, and NIH: The Evolution of a Common Protocol Template

Session Chair(s)

Stacy  Tegan

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

An FDA Reviewer’s Perspective on the Common Protocol Template

Eileen E. Navarro Almario, MD, MS, FACP

FDA, United States

Lead Physician

Cynthia  Boucher, MS

Collaboration between NIH, FDA, and TransCelerate to Create Harmonized Protocol Templates

Cynthia Boucher, MS

National Institutes of Health (NIH), United States

Clinical Trials Specialist

Mitzi  Allred, PhD

TransCelerate’s Technology Enabled Common Protocol Template

Mitzi Allred, PhD

Merck & Co., Inc, United States

Director, Clinical Operations

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