A study protocol is a comprehensive plan or document that outlines the design, objectives, methodology, statistical considerations, and organisation of a research project. It serves as a blueprint for the study, ensuring that all aspects are well-thought-out, standardised, and consistently applied.
Why is it important?
It ensures that the study design and methodology are clearly defined, helping to avoid ambiguity and ad hoc decision-making.
It demonstrates accountability and allows for replication, which is critical for scientific integrity.
It may be required by a Human Research Ethics Committee (HREC)
It standardises procedures across all researchers and study sites, minimising variability and bias.
Many journals and funding bodies require protocols to assess the feasibility and validity of the research.
A well-constructed protocol ensures resources are used efficiently and reduces the risk of inconclusive or invalid results.
How to develop a protocol
Protocols may vary depending on your study design and organisational requirements. Generally, a protocol will do the following:
