Writing a research protocol is an essential first step when planning any type of study or clinical trial. A protocol outlines the background, rationale, objectives, design, methodology, statistical analysis plan, and organization of your research. Having a well-written protocol sets your project up for success and can help secure funding.
As a researcher writing a protocol may seem like a daunting task. Protocols can be complex documents full of scientific jargon and details. However a good protocol should be clear, concise, and easy to follow – even for someone outside your field. Here are some tips to help you write an effective research protocol
Choose a Descriptive Title
Your protocol title should clearly convey the purpose of your study. Aim for a title that is about 10-15 words long. Include keywords related to the research question, population, and study design. For example:
“A Randomized Controlled Trial of a Mobile Health Intervention for Weight Loss in Obese Adults”
Start With an Executive Summary
The executive summary should provide a high-level overview of your protocol. Cover the key points in 1-2 paragraphs:
- Background and rationale
- Study objectives/aims
- Study population and setting
- Study design and methodology
- Statistical analysis plan
- Expected outcomes
This summary gives readers context before diving into the details.
Provide Background and Significance
The introduction should explain the background and rationale behind your research:
- What is the problem or knowledge gap you aim to address?
- Elaborate on the existing literature and any relevant theories or models.
- Justify the need for this study – how will it add to the current body of knowledge?
Support statements with citations pointing to seminal studies. Show reviewers why this project matters and how it will advance the field.
Clearly State the Research Objectives
The objectives section should concisely outline the aims of your study. Good objectives are SMART (specific, measurable, achievable, relevant, and time-bound). Examples:
- To assess the effectiveness of a 12-week low-carb diet on weight loss in obese adults over a 6-month period.
- To determine factors that influence medication adherence in patients with diabetes in a rural community health clinic.
Well-defined objectives keep your study focused and guide later aspects like data analysis.
Provide Detailed Methods and Procedures
The methods section is the heart of your protocol. Thoroughly describe your study design, setting, population, variables, data collection tools, and statistical analysis plan. Consider sections on:
Study Design
Explain whether your study is experimental or quasi-experimental, randomized or non-randomized, retrospective or prospective, qualitative or quantitative.
Study Population
Specify inclusion and exclusion criteria. Detail how many participants you plan to recruit and from where.
Study Setting
Note if your study will take place in a lab, clinic, community setting, online platform, etc.
Variables
Identify all independent and dependent variables you will measure. Operationalize variables clearly.
Data Collection Tools
Describe questionnaires, instruments, and technologies you will use to collect data. Justify their validity and reliability.
Statistical Analysis Plan
Specify which quantitative/qualitative methods you will use to analyze variables and test hypotheses.
Describe Potential Limitations and Challenges
Addressing potential limitations shows reviewers that you have critically assessed your methods. Discuss validity threats, sources of bias, and other challenges. Explain how you will mitigate limitations.
Make an Outline Before Drafting
Outlining gives your protocol structure before you write full paragraphs. Group related sections together in a logical flow. Use headings and bullet points to organize ideas.
Use Simple Language and Define Jargon
Write for an educated reader who may not have deep expertise in your niche. Define technical terms and explain disciplinary jargon. Favor simple sentences and ELI5 (Explain Like I’m 5) writing style.
Be Consistent with Guidelines
Many funders and journals provide protocol templates. Use these to ensure your format aligns with guidelines. Stick to established conventions for citing sources.
Refine Through Multiple Drafts
Treat protocol writing as an iterative process. After completing a full rough draft, take a break then come back to revise with fresh eyes. Seek feedback from colleagues. Refine your protocol until it is polished.
Writing a solid research protocol takes time and attention to detail. Following these tips can help you produce a clear, comprehensive document that reviewer will appreciate. With a finely crafted protocol as your guide, you can proceed confidently into the next phases of your research.
Duration of the project
The protocol should specify the time that each phase of the project is likely to take, along with a detailed month by month timeline for each activity to be undertaken.
This section should discuss the difficulties that the investigators anticipate in successfully completing their projects within the time frame stipulated and the funding requested. It should also offer possible solutions to deal with these difficulties.
This section should describe the role and responsibility of each member of the team
The protocol should have a description of ethical considerations relating to the study. This should not be limited to providing information on how or from whom the ethics approval will be taken, but this section should document the issues that are likely to raise ethical concerns. It should also describe how the investigator(s) plan to obtain informed consent from the research participants (the informed consent process).
The approved version of the protocol must have copies of informed consent forms (ICF), both in English and the local language in which they are going to be administered. However translations may be carried out after the English language ICF(s) have been approved by the ERC. If the research involves more than one group of inpiduals, for example healthcare users and healthcare providers, a separate specifically tailored informed consent form must be included for each group. This ensures that each group of participants will get the information they need to make an informed decision. For the same reason, each new intervention also requires a separate informed consent form.
Research protocol: part 2
The budget section should contain a detailed item-wise breakdown of the funds requested for, along with a justification for each item.
Study goals and objectives
Goals are broad statements of what the proposal hopes to accomplish. They create a setting for the proposal. Specific objectives are statements of the research question(s). Objectives should be simple (not complex), specific (not vague), and stated in advance (not after the research is done). After statement of the primary objective, secondary objectives may be mentioned.
The scientific integrity of the study and the credibility of the study data depend substantially on the study design and methodology. The design of the study should include information on the type of study, the research population or the sampling frame, and who can take part (e.g. inclusion and exclusion criteria, withdrawal criteria etc.), and the expected duration of the study
Note: The same study can be described in several ways, and as complete a description of the study as possible should be provided. For example, a study may be described as being a basic science research, epidemiologic or social science research, it may also be described as observational or interventional; if observational, it may be either descriptive or analytic, if analytic it could either be cross-sectional or longitudinal etc. If experimental, it may be described as a controlled or a non controlled study. The link below provides more information on how to describe a research study.
The methodology section is the most important part of the protocol. It should include detailed information on the interventions to be made, procedures to be used, measurements to be taken, observations to be made, laboratory investigations to be done etc. If multiple sites are engaged in a specified protocol, methodology should be standardized and clearly defined.
Interventions should be described in detail, including a description of the drug/device/vaccine that is being tested. Interventions could also be in the realm of social sciences for example providing training or information to groups of inpiduals.
Procedures could be biomedical (collection of blood or sputum samples to develop a diagnostic test), or in the realm of social sciences (doing a questionnaire survey, carrying out a focus group discussion as part of formative research, observation of the participants environment, etc.).
Standardized and/or documented procedures/techniques should be described and bibliographic references, if not provided earlier should be provided. Instruments which are to be used to collect information (questionnaires, FGD guides, observation recording form, case report forms etc.) must also be provided.
In the case of a randomized controlled trial additional information on the process of randomization and blinding, description of stopping rules for inpiduals, for part of the study or entire study, the procedures and conditions for breaking the codes etc. should also be described.
A graphic outline of the study design and procedures using a flow diagram must be provided. This should include the timing of assessments.
The safety of research participants is foremost. Safety aspects of the research should always be kept in mind and information provided in the protocol on how the safety of research participants will be ensured. This can include procedures for recording and reporting adverse events and their follow-up, for example. It is useful to remember that even administering a research questionnaire can have adverse effects on inpiduals.
The research protocol must give a clear indication of what follow up will be provided to the research participants and for how long. This may include a follow u, especially for adverse events, even after data collection for the research study is completed.
How to Write a Successful Research Proposal | Scribbr
FAQ
What does a research protocol include?
What are the requirements for a research protocol?
What should be included in a protocol?
The typical contents of the protocol are described below, but it is important to always bear in mind the need for detail – the protocol should explain exactly what will be done, to whom, by whom and when. A researcher from another hospital should be able to read your protocol and exactly reproduce the study at their site.
How to write a research protocol?
Writing a complete and detailed document is a paramount step before starting a research projects. The protocol, as described in this paper, should be simply and correctly written but must clarify all the aspects of the protocol. The document could be divided into three different sessions to give all the parts the appropriate attention.
What is a study protocol?
A study protocol is an important document that specifies the research plan for a clinical study. Many funders such as the NHS Health Research Authority encourage researchers to publish their study protocols to create a record of the methodology and reduce duplication of research effort.
What should be included in a study protocol?
A study protocol is an important document that specifies the research plan for a clinical study. It should be written in detail and researchers should aim to publish their study protocols as it is encouraged by many funders. The spirit 2013 statement provides a useful checklist on what should be included in a research protocol [ 1 ].
