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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
![Amy Holbrook](/_Images/member/Generic_Image_Missing-Profile.jpg)
Speaker
Amy Holbrook
Keryx Biopharmaceuticals, United States
Director of Medical Writing
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