... the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH Good Clinical Practice Guideline, the term protocol refers to both protocol and protocol amendments."2 Every clinical trial has a carefully designed plan that provides complete details on the conduct of the trial. The protocol is principally written by the physician or the sponsor of the trial and it is provided to all the physicians helping to carry out the trial.3 The protocol provides details on the following: Justification for conducting the study; Types of people and the number of people needed to answer the question being studies; Schedule of tests and procedures involved in the study; Medications and/or medical devices involved; Length of the study; Plan for analysing the data produced; Guidelines and rules for stopping the study and ending the study. The point of a clinical trial protocol is ...

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