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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

      Speaker

      TK Booker Porter

      • Senior Manager Global Regulatory Writing, Protocol Authoring Lead
      • Amgen, Inc., United States
      Robin  Whitsell

      Speaker

      Robin Whitsell

      • President
      • Whitsell Innovations, Inc., United States
      Amy  Holbrook

      Speaker

      Amy Holbrook

      • Director of Medical Writing
      • Keryx Biopharmaceuticals, United States