Clinical Guides: Planning a Research Project: Protocols

What is a study protocol?

A protocol is a detailed plan for a research study, outlining the specifics of how the research will be conducted. It is an essential document that helps to ensure research is conducted in a safe and ethical manner, and that the integrity of the research is preserved throughout the life of the study.

A protocol -- or Project Description -- is a mandatory component of a Human Research Ethics Application (HREA). It is also required for most grant applications.

Common elements of a protocol

Different study designs require different protocols. A clinical trial protocol differs from that of a cohort study. Click through to the next tab in this box for templates and examples of various protocols. Below is a list of common protocol elements.

- Administrative information - study title, details of authors of the protocol
- Background and rationale
- Research question
- Objectives
- Study design
- Population – selection (inclusion and exclusion criteria) & withdrawal
- Participant recruitment procedures
- Consent procedures
- Details of all study procedures
- Statistics – sample size justification & key elements of the statistical analysis plan (if needed a detailed analysis plan may be prepared separately)
- Outcomes
- Source documents
- Quality control/assurance
- Study oversight
- Ethics
- Data management

Melbourne Children's Trials Centre. (2017). Developing, amending and complying with research protocols. https://www.mcri.edu.au/images/research/training-resources/research-process-resources/guideline_developing_research_protocols.pdf

See the Data Management page in this guide for information on creating a data management plan (DMP), plus online tools and templates.

Literature review

Protocols draw on relevant literature at multiple points, e.g. in background information, when providing a rationale for the study, and when discussing known risks and benefits. If you haven't yet completed a literature search, now is the time to do one!

The Library offers training and guidance on conducting literature reviews, including a webinar on literature searching and a Literature Searching Guide.

Library research support

The Library offers various forms of research support depending on the purpose of your research. Our research support includes:

Research consultations
Literature search service
Literature review report service
Feedback on your literature search strategy
Co-authorship for systematic reviews and other evidence synthesis projects

Complete this online form to request research support and learn more about each service offered.

Request research support

For an overview of Library research support, click the link below.

Library Research Support Services

Additional resources

Protocol writing in clinical research (2016) by A. Al-Jundi & S. Sakka
Write an error-free research protocol as recommended by WHO: 21 elements you shouldn't miss! (2022) by U. Bhosale
How to Write a Research Protocol: Tips and Tricks (2018) by M. Cameli
Guidance: Developing a protocol for a clinical research project (n.d.) by the Clinical Research Development Office, RCH

Protocol templates

The Murdoch Children's Research Institute (MCRI) provides annotated protocol templates for the following study designs:

Clinical trial - drug/device intervention
Clinical trial - intervention is not drug/device
Observational studies
Clinical audits / Quality assurance

To access the templates, click the blue button below and scroll down to the section on Clinical Research Development Office (CRDO) resources.

MCRI protocol templates

Qualitative studies

The NHS Health Research Authority offers a protocol template for qualitative research at the bottom of the page linked below.

NHS Qualitative protocol template

Example protocols

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

Tip: The results of your literature search may include published protocols relevant to your research question.

Journal requirements

Journals that publish study protocols provide guidelines for the content required in protocol manuscripts. It can be helpful to review these guidelines even if you do not intend to publish your protocol in a peer-reviewed journal.

Search for the manuscript guidelines for your preferred journal(s) or review the examples below.

BMC Nursing
BMC Trials

Registering or publishing your protocol

Researchers are encouraged to submit their protocol for publication in a scholarly journal, and/or register their protocol in a relevant database. Many funding agencies also require grant recipients to register or publish their study protocol.

Where to register your protocol

Your study design generally determines where you register your protocol. See the table below for options on where to register your protocol.

Study design(s)	Register protocol in...
Systematic reviews, rapid reviews, umbrella reviews, scoping reviews	BMC Journals JBI Systematic Review Register OSF (Open Science Framework) PROSPERO (does not accept scoping reviews)
Clinical trials (Incl. RCTs)	One or more trials registries Australian Australian New Zealand Clinical Trials Registry (ANZTCR) Australian Clinical Trials International ClinicalTrials.gov ICTRP (International Clinical Trials Registry Platform) OSF (Open Science Framework)
Observational Studies (Incl. cohort studies, case-control studies, cross-sectional studies, ecologic studies)	Australian Australian New Zealand Clinical Trials Registry (ANZTCR) International OSF (Open Science Framework)
Qualitative studies	Australian Australian New Zealand Clinical Trials Registry (ANZTCR) Australian Clinical Trials International ClinicalTrials.gov OSF (Open Science Framework)

Where to publish your protocol

There are two main options:

A journal from your discipline which accepts protocols for publication
- E.g. Journal of Clinical Epidemiology, Journal of Allied Health, Journal of Clinical Nursing
A journal dedicated to publishing protocols
- E.g. BMC Trials, JMIR Research Protocols, Contemporary Clinical Trials

Be aware of predatory publishers - Check our our Writing, Referencing & Publishing Guide or our Predatory Publishing A-Z for more information.

Ensure that you are aware of relevant Monash Health policies, guidelines, and procedures via Prompt. Prompt is available on all Monash Health PCs.

Relevant Prompt documents include:

Research Agreements Procedure
Publication and dissemination of research findings
Intellectual Property
Research Ethics and Governance – Protocol and Investigational Brochure Content, Design, Amendments and Compliance
Privacy and Confidentiality in Research
Research Ethics and Governance – Authorship for Research

Visit the Forms Library from Research Support Services for links and more information.

Research - Forms Library

Research agreements

The Research Agreements Procedure provides guidance on which agreement to use in which circumstance and the pathway to follow for seeking review and approval. There are preferred templates for various types of studies, such as collaborative or investigator-initiated studies.

For more information, visit the Research Agreements page from Research Support Services.

Research Agreements page

Protocol amendments

Once your protocol is finalised and ethics approval has been granted, you must notify the Monash Health Research Support Services team regarding protocol amendments.