The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.
Regulatory and Industry Perspectives on the Common Protocol Template
Robert A. DiCicco, PharmD
TransCelerate Biopharma Inc., United States
Protocols are critical components of a medical product development program. Having a standard format and structure, as well as content from CDISC therapeutic area standards will allow sponsors and regulatory agencies be able to find the same information in the same location and it will mean the same thing.
This session will provide an update on the regulatory and industry perspectives on the benefits/challenges of a common protocol template for regulated global clinical trials and progress toward its adoption and maintenance.
Learning Objective : Describe the benefits of a common protocol template for industry and regulatory agencies; Recognize the challenges of a common protocol template multi-regional clinical trials; Explain the progress toward the use and maintenance of a common protocol template
Kenneth A. Getz, DIAFellow, MBA
Director of Sponsored Research Programs and Associate Professor
Center For the Study of Drug Development, Tufts University School of Medicine, United States
Vaishali Popat, MD, MPH
Associate Director of Biomedical Informatics and Reg Review Science, OND, CDER
FDA, United States
NIH-FDA Protocol Template and the Benefits of Having a Common Protocol Template for Phase 2 and 3 Trials
Clinical Trials Specialist
National Institutes of Health (NIH), United States
Health Canada, Canada