Clinical Guides: Planning a Research Project: Develop Protocol

Developing a study protocol

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:

Define the research question, aims, and hypothesis
Review the literature
Choose an appropriate study design
Define your inclusion and exclusion criteria
Define your primary and additional outcomes
Detail your data collection methods
Address ethical considerations
Detail how results will be shared
Identify budget and funding

Examples

RCT - A clinical investigation evaluating efficacy of a full-thickness placental allograft (Revita) in lumbar microdiscectomy outcomes
Observational study - Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE)
Systematic review and meta-analysis - Protocol for a systematic review and meta-analysis on the associations between shift work and sickness absence

Recommended resources:

Al-Jundi, A., et al. (2016). Protocol Writing in Clinical Research. Journal of clinical and diagnostic research, 10(11), ZE10–ZE13.
Cameli, M., et al. (2018). How to Write a Research Protocol: Tips and Tricks. Journal of cardiovascular echography, 28(3), 151–153.
Clinical Research Development Office. (n.d.) Guidance: Developing a protocol for a clinical research project.
NHS. (2018). Protocol.

Mars Global. (2023). How to Write and Publish a Clinical Research Protocol?

Registering a study protocol

Registering a study protocol in a journal or repository is an important step in ensuring transparency, credibility, and accountability in research.

Why is it important?

It prevents selective reporting and increases transparency.
It enhances reproducibility and transparency.
It facilitates collaboration and meets funding or publishing requirements.
It contributes to evidence synthesis.

Where do you register a study protocol?

Where you register your protocol will depend on your study type and any requirements by the funding body.