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

    Session Chair(s)
      Stacy J. Tegan

      Stacy J. Tegan

      • Manager, Regulatory Technology Consulting
      • Accenture Accelerated R&D Services, 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)
      Representative Invited

      An FDA Reviewer’s Perspective on the Common Protocol Template

      Representative Invited

      • FDA, United States
      Representative  Invited

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

      Representative Invited

      • Mexico
      Mitzi  Allred, PhD

      TransCelerate’s Technology Enabled Common Protocol Template

      Mitzi Allred, PhD

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