A research protocol is a document that describes the background, rationale, objectives, design, methodology, statistical considerations, and organization of a clinical research project. Objectives/Purpose. Study Design. Selection and organization of a clinical research project.

More than an instruction manual, the protocol serves many purposes. It is the mech- anism the investigator uses for translating an idea into a clinical trial. Writing a protocol allows the investigator to carefully consider the research question, its clinical importance, and the feasibil- ity of conducting the study.

Protocol Development is a legal requirement which is relevant to all trials. 

The protocol provides information on the background and rationale for a trial and outlines the study plan. The plan must be carefully designed to safeguard the health and safety of the participants, as well as answer the research question