The research protocol is an essential part of a research project. It is a full description of the research study and will act as a ‘manual’ for members of the research team to ensure everyone adheres to the methods outlined. As the study gets underway, it can then be used to monitor the study’s progress and evaluate its outcomes. No two research protocols will be the same, but there are common elements and items that need to be addressed. Use the templates below to see examples of the kinds of headings your protocol needs to contain. The protocol should describe as much detail about the research project as possible, to enable the review bodies to fully understand your study. It should be kept up to date as the research evolves, and include a version number and approval history.
This topic describes: Study Summary, List of Abbreviations, Background Information/Significance, Objectives/Rationale/Research Question, Clinical Study Design, Inclusion and Exclusion criteria of the Subjects, Informed consent form process, Adverse Event Reporting, Assessment of Safety and Efficacy, Treatment of Subjects, Data Collection Plan, Data Access, Statistical Methods, Conflict of Interest, Publication and Presentation Plans and Timeline.