The study protocol is “the most important document in clinical trials, since it ensures the quality and integrity of the clinical investigation in terms of its planning, execution, conduct, and the analysis of the data” (Chow & Chang, 2007). The study protocol is a comprehensive plan of action that contains information concerning the goals of the study, details of subject recruitment, details of safety monitoring, and all aspects of design, methodology, and analysis. (In some cases, a Statistical Analysis Plan, associated with and written at the same time as the study protocol, will contain the detailed description of the analyses to be conducted.)
The creation of study protocol requires input from many individuals. Consider a study protocol for a pharmaceutical clinical trial, since this is likely to be more extensive (and complex) than some smaller trials for behavioral medicine interventions and treatments. By considering this more extensive version, one will.
