A study protocol is a comprehensive document that outlines the objectives, methods, design, and logistics of a research study. It serves as a roadmap for researchers, detailing the entire process from start to finish. It includes specific information such as the research question or hypothesis, study population, inclusion and exclusion criteria, data collection procedures, statistical analysis plan, ethical considerations, and potential risks and benefits for participants. In summary, it provides a structured framework for conducting research and ensures consistency and transparency in the scientific process. Moreover, the study protocol is essential for any Institutional Ethics Board to reach a conclusion on the permissibility of a study.
NIH – National Institutes of Allergy and Infectious Diseases. Protocols and Informed consent.
More resources
World Health Organization (WHO) Recommended format for a ‘research protocol’
Encyclopedia of Behavioral Medicine by Turner, J.R. (2013). In: Gellman, M.D., Turner, J.R. (eds) Encyclopedia of Behavioral Medicine. Springer, New York, NY.
NHS – Health Research Authority
What is a research protocol?
This is a short animation created by the Research & Development Team at Cumbria, Northumberland, Tyne & Wear NHS Foundation Trust. The video focuses on research protocols, why they are important, what they should include, and version control.
