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Joby George has sent a Standard Operating Procedure showing a template for a research protocol. It describes what a reserach protocol is and what is must include.
He explains in the document that the nature and conduct of a study will be described in a clear and detailed protocol. Protocols will be written in accordance with the principles of ICH Good Clinical Practice (GCP), Schedule Y, and will describe the objective(s), design, methodology, statistical considerations and organization of a study. Protocols must be carefully designed to safeguard the health and safety of the participants, as well as answer specific research questions.