Objectives and Guiding Principles for the Implementation Leader December 2017

Objectives and Guiding Principles for the Implementation Leader The Implementation Materials are: High level roadmap of activities designed to support implementation of the Common Protocol Template (CPT) across project management, people, process & technology Templates and materials to communicate the initiative to various audiences Available to any company or sponsor who chooses to implement .. but are not: A detailed step-by-step workplan Activities that must be followed exactly, including company or sponsor-specific documentation The materials can be used in a highly flexible manner, as reflected in the guiding principles below. i Guiding Principles Each company or sponsor is free to decide and must decide for itself whether and in what manner to adopt any or all of the CPT components. These materials are intended to help those Companies or Sponsors who decide to adopt any CPT component to do so in the most efficient way possible. Implementation components are generic and may need to be tailored to a specific company prior to use. While companies or sponsors have absolute discretion to implement TransCelerate solutions as they see fit, changing certain CPT tools will likely reduce some of the efficiencies for sites, investigators, and sponsors. It is up to each company or sponsor to define further the detailed steps for each implementation component within their respective organization. Legally approved 8-Apr-2017