The IRB protocol is the formal design of plan for the proposed experiment or research activity. A protocol is a document that describes the parameters of a research experiment in detail. The protocol includes a description of the research design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimen(s), and the proposed methods of analysis that will be performed on the collected data. The information provided must be descriptive enough to facilitate the understanding of a review without leaving too many unanswered questions. However please be as brief as possible but all questions on the application must be answered completely.