A research protocol is a document that describes the background, rationale, objectives, design, methodology, statistical considerations, and organization of a clinical research project
The paper should consist of following information below
General information
Protocol title, protocol identifying number (if any), and date.
Expected Outcomes of the Study
Dissemination of Results and Publication Policy
The protocol should specify not only dissemination of results in the scientific media, but also to the community and/ or the participants, and consider dissemination to the policy makers where relevant.
Duration of the Project
The protocol should specify the time that each phase of the project is likely to take, along with a detailed month by month timeline for each activity to be undertaken.
Problems Anticipated
This section should discuss the difficulties that the investigators anticipate in successfully completing their projects within the time frame stipulated and the funding requested.
Ethics
The protocol should have a description of ethical considerations relating to the study.