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Omni Rancho Las Palmas Resort & Spa

Mar 19, 2018 1:00 PM - Mar 21, 2018 4:00 PM

41000 Bob Hope Drive, Rancho Mirage, CA 92270

Medical Affairs and Scientific Communications Forum

Medical Communication, MSL, and Medical Writing.

Session 7 Track 2: Contemplate Your Template: New or Used Options for Protocol Development

Session Chair(s)

Robin  Whitsell

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:

  • Discuss the TransCelerate Biopharma Common Protocol Template (CPT) and the NIH-FDA template
  • List the components (regulatory requirements and document architecture) of a well-written protocol
  • Analyze the factors that influence your selection of a protocol template
  • Speaker(s)

    TK  Booker Porter, PhD

    Speaker

    TK Booker Porter, PhD

    Greenwich BioSciences, United States

    Senior Director, Global Medical Writing and Regulatory Operations

    Robin  Whitsell

    Speaker

    Robin Whitsell

    Whitsell Innovations, Inc., United States

    President

    Amy  Holbrook

    Speaker

    Amy Holbrook

    Keryx Biopharmaceuticals, United States

    Director of Medical Writing

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