Regulatory and Industry Perspectives on the Common Protocol Template
Robert A. DiCicco, PharmD
Vice President, Clinical Innovation and Digital Platforms
GlaxoSmithKline, 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 multiregional clinical trials; Explain the progress toward the use and maintenance of a common protocol template.