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Session 7 Track 2: Contemplate Your Template: New or Used Options for Protocol Development
Session Chair(s)
Robin Whitsell
President
Whitsell Innovations, Inc., United States
Recently, TransCelerate Biopharma and the NIH-FDA issued protocol templates. These documents have led medical writers to reconsider the available protocol templates of their organizations. The use of a common template for protocols can facilitate consistency among investigators, increasing operational efficiencies at investigative sites and easing review by health authorities. This session will introduce the newly-issued TransCelerate Biopharma Common Protocol Template (CPT) and the NIH-FDA template. The speakers will detail the benefits and limitations of these templates, and factors for consideration when using them. In addition, this session will host a case-study on creating your own protocol template, ensuring that content requirements are met, and getting endorsement from your study development team.
Learning Objective :
At the conclusion of this session, participants should be able to:
Speaker(s)
Speaker
TK Booker Porter, PhD
Greenwich BioSciences, United States
Senior Director, Global Medical Writing and Regulatory Operations
Speaker
Robin Whitsell
Whitsell Innovations, Inc., United States
President
Speaker
Amy Holbrook
Keryx Biopharmaceuticals, United States
Director of Medical Writing
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