A protocol is the document that outlines the study plan for a clinical research project. The study plan must be carefully designed to ensure it protects the health and safety of participants as well as answer a research question. It ensures the integrity of the research is preserved throughout the life of the study.
Different study designs require different protocols. Below is a list of common protocol elements.
Background
- Analysis of previous literature and studies
- Rationale of the project
Aim
- Research question
- Objectives
Plan of investigation
- Study design
- Description of the study population and study groups
- Sequence of procedures
- Variables to be measured and measurement methods
- Planned statistical analyses
A protocol is a mandatory component of a Human Research Ethics Application and is required for most grant applications. Protocol templates are available via HNELHD Research Office.
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