ABSTRACT
Once through with the steps mentioned in the preceding chapters, a researcher is ready to develop a protocol for the research project. The protocol is the document that outlines the proposed research, gives its full rationale, including the objectives and the hypotheses, and the complete methodology, including the system for reaching an unbiased and credible conclusion. This is the final step in planning research and is the backbone that supports it in all steps of its execution. It serves as a reference for the members of the research team whenever needed.
This chapter describes the structure and contents of a medical research protocol, and is divided into two sections. The first section is on the structure of the protocol such as title, collaborators, and supervisors, executive summary, and logistics, and the second section is on the contents of the main body of the protocol such as background, review of the literature, objectives and hypothesis, target population, sampling and sample size, method of eliciting the information, data collection and analysis, and the system of reaching a valid conclusion.
