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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

      • Manager, Regulatory Technology Consulting
      • Accenture, 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
      Eileen E. Navarro Almario, MD, MS, FACP

      An FDA Reviewer’s Perspective on the Common Protocol Template

      Eileen E. Navarro Almario, MD, MS, FACP

      • Lead Medical Officer, OCS, OTS, CDER
      • FDA, United States
      Cynthia  Boucher, MS

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

      Cynthia Boucher, MS

      • Clinical Trials Specialist
      • National Institutes of Health (NIH), United States
      Mitzi  Allred, PhD

      TransCelerate’s Technology Enabled Common Protocol Template

      Mitzi Allred, PhD

      • Director, Clinical Trial Operations
      • Merck & Co., Inc., United States