clinical research essay 2

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CLINICAL RESEARCH

Title: "Write a clinical trial protocol for a novel drug."

"The protocol is at the heart of every clinical trial. It is the plan; it is a critical document for everyone involved in the conduct of the trial."1 Principally a protocol involves selecting investigative sites and designing the data collection tools; it also describes how individual trial subjects should be treated and evaluated. Quite importantly it "serves as a reference for monitoring and auditing trial conduct and it conveys the plan for analysing the data when the study is complete."1 An "Institutional Review Board (IRBs) or Ethics Committees use the protocol as the basis for approving whether a trial can be initiated." A protocol that is constructed thoroughly aids to ensure "common understanding of the study objectives and procedures to be implemented, thereby improving quality and saving time and effort for those using it."1

The International Conference on Harmonization (ICH) defines a protocol as; "a document that describes the objective(s), design, methodology, statistical considerations and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the