what is a research study protocol

Write an Error-free Research Protocol As Recommended by WHO: 21 Elements You Shouldn’t Miss!

Principal Investigator: Did you draft the research protocol?

Student: Not yet. I have too many questions about it. Why is it important to write a research protocol? Is it similar to research proposal? What should I include in it? How should I structure it? Is there a specific format?

Researchers at an early stage fall short in understanding the purpose and importance of some supplementary documents, let alone how to write them. Let’s better your understanding of writing an acceptance-worthy research protocol.

Table of Contents

What Is Research Protocol?

The research protocol is a document that describes the background, rationale, objective(s), design, methodology, statistical considerations and organization of a clinical trial. It is a document that outlines the clinical research study plan. Furthermore, the research protocol should be designed to provide a satisfactory answer to the research question. The protocol in effect is the cookbook for conducting your study

Why Is Research Protocol Important?

In clinical research, the research protocol is of paramount importance. It forms the basis of a clinical investigation. It ensures the safety of the clinical trial subjects and integrity of the data collected. Serving as a binding document, the research protocol states what you are—and you are not—allowed to study as part of the trial. Furthermore, it is also considered to be the most important document in your application with your Institution’s Review Board (IRB).

It is written with the contributions and inputs from a medical expert, a statistician, pharmacokinetics expert, the clinical research coordinator, and the project manager to ensure all aspects of the study are covered in the final document.

Is Research Protocol Same As Research Proposal?

Often misinterpreted, research protocol is not similar to research proposal. Here are some significant points of difference between a research protocol and a research proposal:

What Are the Elements/Sections of a Research Protocol?

According to Good Clinical Practice guidelines laid by WHO, a research protocol should include the following:

1. General Information

• Protocol title, protocol identifying number (if any), and date.
• Name and address of the funder.
• Name(s) and contact details of the investigator(s) responsible for conducting the research, the research site(s).
• Responsibilities of each investigator.
• Name(s) and address(es) of the clinical laboratory(ies), other medical and/or technical department(s) and/or institutions involved in the research.

2. Rationale & Background Information

• The rationale and background information provides specific reasons for conducting the research in light of pertinent knowledge about the research topic.
• It is a statement that includes the problem that is the basis of the project, the cause of the research problem, and its possible solutions.
• It should be supported with a brief description of the most relevant literatures published on the research topic.

3. Study Objectives

• The study objectives mentioned in the research proposal states what the investigators hope to accomplish. The research is planned based on this section.
• The research proposal objectives should be simple, clear, specific, and stated prior to conducting the research.
• It could be divided into primary and secondary objectives based on their relativity to the research problem and its solution.

4. Study Design

• The study design justifies the scientific integrity and credibility of the research study.
• The study design should include information on the type of study, the research population or the sampling frame, participation criteria (inclusion, exclusion, and withdrawal), and the expected duration of the study.

5. Methodology

• The methodology section is the most critical section of the research 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.
• The methodology should be standardized and clearly defined if multiple sites are engaged in a specified protocol.

6. Safety Considerations

• The safety of participants is a top-tier priority while conducting clinical research .
• Safety aspects of the research should be scrutinized and provided in the research protocol.

7. Follow-up

• The research protocol clearly indicate of what follow up will be provided to the participating subjects.
• It must also include the duration of the follow-up.

8. Data Management and Statistical Analysis

• The research protocol should include information on how the data will be managed, including data handling and coding for computer analysis, monitoring and verification.
• It should clearly outline the statistical methods proposed to be used for the analysis of data.
• For qualitative approaches, specify in detail how the data will be analysed.

9. Quality Assurance

• The research protocol should clearly describe the quality control and quality assurance system.
• These include GCP, follow up by clinical monitors, DSMB, data management, etc.

10. Expected Outcomes of the Study

• This section indicates how the study will contribute to the advancement of current knowledge, how the results will be utilized beyond publications.
• It must mention how the study will affect health care, health systems, or health policies.

11. Dissemination of Results and Publication Policy

• The research protocol should specify not only how the results will be disseminated in the scientific media, but also to the community and/or the participants, the policy makers, etc.
• The publication policy should be clearly discussed as to who will be mentioned as contributors, who will be acknowledged, etc.

12. Duration of the Project

• The protocol should clearly mention the time likely to be taken for completion of each phase of the project.
• Furthermore a detailed timeline for each activity to be undertaken should also be provided.

13. Anticipated Problems

• The investigators may face some difficulties while conducting the clinical research. This section must include all anticipated problems in successfully completing their projects.
• Furthermore, it should also provide possible solutions to deal with these difficulties.

14. Project Management

• This section includes detailed specifications of the role and responsibility of each investigator of the team.
• Everyone involved in the research project must be mentioned here along with the specific duties they have performed in completing the research.
• The research protocol should also describe the ethical considerations relating to the study.
• It should not only be limited to providing ethics approval, but also the issues that are likely to raise ethical concerns.
• Additionally, the ethics section must also describe how the investigator(s) plan to obtain informed consent from the research participants.
• This section should include a detailed commodity-wise and service-wise breakdown of the requested funds.
• It should also include justification of utilization of each listed item.

17. Supplementary Support for the Project

• This section should include information about the received funding and other anticipated funding for the specific project.

18. Collaboration With Other Researchers or Institutions

• Every researcher or institute that has been a part of the research project must be mentioned in detail in this section of the research protocol.

19. Curriculum Vitae of All Investigators

• The CVs of the principal investigator along with all the co-investigators should be attached with the research protocol.
• Ideally, each CV should be limited to one page only, unless a full-length CV is requested.

20. Other Research Activities of Investigators

• A list of all current research projects being conducted by all investigators must be listed here.

21. References

• All relevant references should be mentioned and cited accurately in this section to avoid plagiarism.

How Do You Write a Research Protocol? (Research Protocol Example)

Main Investigator    

Number of Involved Centers (for multi-centric studies)

Indicate the reference center

Title of the Study

Protocol ID (acronym)

Keywords (up to 7 specific keywords)

Study Design

Mono-centric/multi-centric

Perspective/retrospective

Controlled/uncontrolled

Open-label/single-blinded or double-blinded

Randomized/non-randomized

n parallel branches/n overlapped branches

Experimental/observational

Endpoints (main primary and secondary endpoints to be listed)

Expected Results                                                

Analyzed Criteria

Main variables/endpoints of the primary analysis

Main variables/endpoints of the secondary analysis

Safety variables

Health Economy (if applicable)

Visits and Examinations

Therapeutic plan and goals

Visits/controls schedule (also with graphics)

Comparison to treatment products (if applicable)

Dose and dosage for the study duration (if applicable)

Formulation and power of the studied drugs (if applicable)

Method of administration of the studied drugs (if applicable)

Informed Consent

Study Population

Short description of the main inclusion, exclusion, and withdrawal criteria

Sample Size

Estimated Duration of the Study

Safety Advisory

Classification Needed

Requested Funds

Additional Features (based on study objectives)

Click Here to Download the Research Protocol Example/Template

Be prepared to conduct your clinical research by writing a detailed research protocol. It is as easy as mentioned in this article. Follow the aforementioned path and write an impactful research protocol. All the best!

Clear as template! Please, I need your help to shape me an authentic PROTOCOL RESEARCH on this theme: Using the competency-based approach to foster EFL post beginner learners’ writing ability: the case of Benin context. I’m about to start studies for a master degree. Please help! Thanks for your collaboration. God bless.

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Article Contents

Introduction, contents of a research study protocol, conflict of interest statement, how to write a research study protocol.

• Article contents
• Figures & tables
• Supplementary Data

Julien Al Shakarchi, How to write a research study protocol, Journal of Surgical Protocols and Research Methodologies , Volume 2022, Issue 1, January 2022, snab008, https://doi.org/10.1093/jsprm/snab008

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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. In this paper, we will describe how to write a research study protocol.

A study protocol is an essential part of a research project. It describes the study in detail to allow all members of the team to know and adhere to the steps of the methodology. Most funders, such as the NHS Health Research Authority in the United Kingdom, encourage researchers to publish their study protocols to create a record of the methodology, help with publication of the study and reduce duplication of research effort. In this paper, we will explain how to write a research protocol by describing what should be included.

Introduction

The introduction is vital in setting the need for the planned research and the context of the current evidence. It should be supported by a background to the topic with appropriate references to the literature. A thorough review of the available evidence is expected to document the need for the planned research. This should be followed by a brief description of the study and the target population. A clear explanation for the rationale of the project is also expected to describe the research question and justify the need of the study.

Methods and analysis

A suitable study design and methodology should be chosen to reflect the aims of the research. This section should explain the study design: single centre or multicentre, retrospective or prospective, controlled or uncontrolled, randomised or not, and observational or experimental. Efforts should be made to explain why that particular design has been chosen. The studied population should be clearly defined with inclusion and exclusion criteria. These criteria will define the characteristics of the population the study is proposing to investigate and therefore outline the applicability to the reader. The size of the sample should be calculated with a power calculation if possible.

The protocol should describe the screening process about how, when and where patients will be recruited in the process. In the setting of a multicentre study, each participating unit should adhere to the same recruiting model or the differences should be described in the protocol. Informed consent must be obtained prior to any individual participating in the study. The protocol should fully describe the process of gaining informed consent that should include a patient information sheet and assessment of his or her capacity.

The intervention should be described in sufficient detail to allow an external individual or group to replicate the study. The differences in any changes of routine care should be explained. The primary and secondary outcomes should be clearly defined and an explanation of their clinical relevance is recommended. Data collection methods should be described in detail as well as where the data will be kept secured. Analysis of the data should be explained with clear statistical methods. There should also be plans on how any reported adverse events and other unintended effects of trial interventions or trial conduct will be reported, collected and managed.

Ethics and dissemination

A clear explanation of the risk and benefits to the participants should be included as well as addressing any specific ethical considerations. The protocol should clearly state the approvals the research has gained and the minimum expected would be ethical and local research approvals. For multicentre studies, the protocol should also include a statement of how the protocol is in line with requirements to gain approval to conduct the study at each proposed sites.

It is essential to comment on how personal information about potential and enrolled participants will be collected, shared and maintained in order to protect confidentiality. This part of the protocol should also state who owns the data arising from the study and for how long the data will be stored. It should explain that on completion of the study, the data will be analysed and a final study report will be written. We would advise to explain if there are any plans to notify the participants of the outcome of the study, either by provision of the publication or via another form of communication.

The authorship of any publication should have transparent and fair criteria, which should be described in this section of the protocol. By doing so, it will resolve any issues arising at the publication stage.

Funding statement

It is important to explain who are the sponsors and funders of the study. It should clarify the involvement and potential influence of any party. The sponsor is defined as the institution or organisation assuming overall responsibility for the study. Identification of the study sponsor provides transparency and accountability. The protocol should explicitly outline the roles and responsibilities of any funder(s) in study design, data analysis and interpretation, manuscript writing and dissemination of results. Any competing interests of the investigators should also be stated in this section.

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 ]. In this paper, we have explained a straightforward approach to writing a research study protocol.

None declared.

Chan   A-W , Tetzlaff   JM , Gøtzsche   PC , Altman   DG , Mann   H , Berlin   J , et al.    SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials . BMJ   2013 ; 346 : e7586 .

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Protocol Writing in Clinical Research

Azzam al-jundi.

1 Professor, Department of Orthodontics, King Saud bin Abdul Aziz University for Health Sciences, College of Dentistry, Riyadh, Kingdom of Saudi Arabia.

Salah Sakka

2 Associate Professor, Department of Oral Surgery, Al Farabi Dental College, Riyadh, Kingdom of Saudi Arabia.

Writing a research proposal is probably one of the most challenging and difficult task as research is a new area for the majority of postgraduates and new researchers. The purpose of this article is to summarize the most important steps and necessary guidelines for producing a standard research protocol. Academic and administrative success of any project is usually determined by acquiring a grant for the related field of research. Hence, the quality of a protocol is primarily required to achieve success in this scientific competition.

What is A Protocol?

Clinical research is conducted according to a plan (a protocol) or an action plan. The protocol demonstrates the guidelines for conducting the trial. It illustrates what will be made in the study by explaining each essential part of it and how it is carried out. It also describes the eligibility of the participants, the length of the study, the medications and the related tests.

A protocol is directed by a chief researcher. The health of the participants’ will be regularly checked by members of the research team to ultimately ensure the study’s safety and effectiveness.

Purpose of a Research Proposal

[ Table/Fig-1 ] outlines the key aims of the protocol.

[Table/Fig-1]:

Aims of the protocol.

Benefits of the Proposal to a Researcher

[ Table/Fig-2 ] outlines the key benefits of the protocol.

[Table/Fig-2]:

Benefits of the protocol.

The key points of the proposal should include justification for the need of the project and a detailed plan for the investigation [ 1 , 2 ]:

What is the question? (Hypothesis) What is it to be investigated?

• Why is the study important? (Significance)
• Where and when it will take place?
• What is the methodology? (Procedures and methods to be used).
• How are you going to do it? (Research design)
• Proposed time table and budget.
• Resources required (technical, scientific, and financial).

Drafting the protocol correctly will increase the likelihood that the conclusions drawn from the research are scientifically sound. Recommendations and suggestions should be sought from colleagues and experts so that researchers can develop their plans. However, once the study is launched, the protocol should not be altered during the progression of the study or trials. If the changes during progress of study are minor, then that part of the study should be excluded from the analysis. Unless unexpected complications occur during the conduct of the trial, it is advisable to reconsider and rewrite the protocol where the whole process is started again provided that the original research topic is still considered to be relevant. If complications are anticipated, it is suitable to run a pilot study, to check the feasibility of the study and find answers to the potential areas of the trial.

What is A Protocol Review?

Clinical trials must be approved and monitored by an Institutional Review Board that ensures that the risks are negligible and are worth any potential benefits. It is an independent committee that consists of physicians, dentists, statisticians, and members of the community.

The committee ensures that clinical trials are ethical and that the rights of all participants are protected. The board must initially approve and periodically review the research.

Components of a Research Protocol: The topics that should be covered in a protocol are shown in [ Table/Fig-3 ] [ 3 , 4 ].

[Table/Fig-3]:

The components of the protocol.

Writing The Protocol

Protocol writing allows the researcher to review and critically evaluate the published literature on the interested topic, plan and review the project steps and serves as a guide throughout the investigation. The proposal is an inevitable document that enables the researcher to monitor the progress of the project [ 5 ].

1) Title of the Study: Title of proposal should be accurate, short, concise, and identify [ 2 , 6 ].

What is the study about, Who are the targets, Where is the setting of the study and When it is launched, if applicable-

It should make the main objective clear, convey the main purpose of the research and mention the target population. Carry maximum information about the topic in a few words; it is a good practice to keep the title to within 12-15 words. It should convey the idea about the area of research and what methods are going to be used in a compact, relevant, accurate, attractive, easy to understand, and informative way.

2) Administrative Details: The following administrative details and a protocol content summary should follow the title page:

• Contents page list of relevant sections and sub-sections with corresponding page number.
• Signature page is signed by senior members of the research team and dated to confirm that the version concerned has been approved by them.
• Contact details for the research team members listing postal, e-mail addresses and telephone numbers.

3) Project Summary: The summary should be distinctive, concise and should sum up all the essentials of the protocol.

4) Introduction (Background): The background to the project should be concise and refer to the subject straight forwardly. In writing the review, attention should be drawn to the positives, negatives and limitations of the studies quoted [ 7 – 9 ]. Introduction is concluded by explaining how the present study will benefit the community. The literature review should logically lead to the statement of the aims of the proposed project and end with the aims and objectives of the study. The review should include the most recent publications in the field and the topic of the research is selected only after completing the literature review and finding some gaps in it.

Introduction should briefly answer the importance of the topic, the gaps/lacunae in the literature, the purpose of the study and benefits for the society, from the study.

The research question should be described precisely and concisely. It is going to be the basis of designing the project. The definition of the problem should be clear so that a reader can straight forwardly recognize the real meaning of it.

5) Study Objectives (Aims): The aims should be explicitly stated. These should be confined to the intention of the project and they should arise from the literature review. State the goal you need to achieve.

The study aims or objectives emerge from the study questions/ hypothesis. They are answers to what are the possible responses to the research question or hypothesis under analysis and measure. Aims should be logical and coherent, feasible, concise, realistic, considering local conditions, phrased to clearly meet the purpose of the study and related to what the specific research is intended to accomplish. For example, to evaluate knowledge level regarding dental caries in primary school children in KSA (this is not detailed). The following should be added: Causes, treatment, preventive measures, etc.

The objectives should be (SMART objective): Specific, Measurable, Achievable, Relevant and Time based [ 10 ].

Specific Aims: Details of each objective that will finally lead to the achievement of the goal should be stated. Specific aims one by one should be listed concisely. It is good practice not to include too many aims in the study (2-5 best); too many objectives often lead to inaccurate and poorly defined results. Furthermore, aims should be achievable, realistic and specific with no general and ambiguous statements. They should be stated in action verbs that illustrate their purpose: i.e., “to determine, to compare, to verify, to calculate, to reduce, to describe, etc.”

Secondary Objectives (Optional): These are referred to as ancillary and minor objectives that could be studied during the course of the study.

The formulation of objectives helps to focus the study and to avoid the collection of any unnecessary data and hence organize the study in clear and distinct stages.

Hypothesis: It is a statement based on sound scientific theory that recognizes the predicted correlation between two or additional assessable variables [ 11 ]. It is always developed in response to the purpose statement or to answer the research questions posed. Furthermore, hypothesis transforms research questions into a format amendable to testing or into a statement that predicts an expected outcome.

Types of hypothesis statements:

• Null hypothesis: A null hypothesis is a statement that there is no actual relationship between variables (H0 or HN). It may be read as there is no difference between the groups to be compared and no relationship between the exposure and outcome under investigation. H0 states the contradictory of what the researchers expect. The final conclusion of the investigators will either keep a null hypothesis or reject it in support of an alternative hypothesis. It does not essentially mean that H0 is accurate when not rejecting it as there might not be an adequate proof against it.
• Alternative hypothesis: An alternative hypothesis is a statement that suggests a potential outcome that the researcher may expect (H1 or HA). This hypothesis is derived from previous studies where an evident difference between the groups to be compared is present. It is recognized only when a null hypothesis is rejected. Practically, hypotheses are stated in the null form, because they have their inferential statistics. Such hypotheses of no difference will be challenged by researchers and the result of the statistical testing gives the probability that the hypothesis of no difference is true or false [ 12 ].

Aims should be logically linked and arranged according to the tested hypothesis statement.

• Research question: Is there a difference in fluoride release between the Compomer and Glass- ionomer cement?
• Null Hypothesis: There is no difference in fluoride release between the Compomer and Glass- ionomer cement.
• Alternate Hypothesis: There is a difference in fluoride release between the Compomer and Glass-ionomer cement.

The statement of the problem should provide a summary of exactly what the project is trying to achieve.

• What exactly do you want to study?
• Why is it worth studying?
• Does the proposed study have theoretical and/or practical significance?
• Does it contribute to a new understanding of a phenomenon? (i.e., Does it address new or little known material or does it treat familiar material in a new way or does it challenge an existing understanding or extend existing knowledge?)

The justification of the research should be a convincing statement for the need to do it:

• How does the research relate to the priorities of the region and the country?
• What knowledge and information will be obtained?
• What is the ultimate purpose that the knowledge obtained from the study will serve?
• How will the results be disseminated?
• How will the results be used, and who will be the beneficiaries?

6) Methods and Materials: It should describe in detail the ‘Where’, ‘Who’, ‘How’ the research will be conducted. It explains the study design and procedures and techniques used to achieve the proposed objectives. It defines the variables and demonstrates in detail how the variables will be measured. It details the proposed methodology for data gathering and processing.

Methodology composes an important part of the protocol. It assures that the hypothesis will be confirmed or rejected. It also refers to a thorough strategy to attain the objectives [ 13 ].

The methods and materials are divided into various subheadings:

a) Study design (cross-sectional, case-control, intervention study, RCT, etc.): Proper explanation should be given as to why a particular design was chosen (on the basis of proposed objectives and availability of resources).

A study design is in fact the researcher’s general plan to acquire the answer (s) to the hypothesis being tested. Here, strategies will be applied to develop balanced, correct, objective and meaningful information [ 14 ]. It explains the methods that will be used to collect and analyze data. Proper selection of the study design is important to attain reliable and valid scientific results.

Ethics, logistic concerns, economic features and scientific thorough-ness will determine the design of the study. Here, a chief concern is given to the legality of the results including potential bias mystifying issues.

Randomized controlled clinical trial is the best to document a causal relationship between an exposure and its outcome [ Table/Fig-4 ].

[Table/Fig-4]:

Suitable research design depends on the purpose of the study.

b) Study population (Study subjects): Where are you going to do the research and who is the study population (why doing research in this place and why selecting this population?).

It describes in detail about the study subjects, all aspects of the selection procedure and sample size calculation. Proper definition of eligibility, inclusion, exclusion and discontinuation criteria of the study subjects should be stated. Allocation of subjects to study arms should be explained and described in details bearing in mind the concealment and randomization process [ 15 , 16 ].

c) Sample size: Sample size calculation is recommended for economical and ethical reasons [ 16 – 18 ]. The calculation of the sample size must be explained including the power of the sample. The sampling technique should be mentioned, e.g., randomization that will be used in order to obtain a representative sample for your target population. Each step involved in the recruitment of the study subjects should be described according to the selection criteria (inclusion and exclusion criteria).

“Informed consent” should be mentioned (Permission granted in full knowledge of the possible consequences).

d) Proposed intervention: Full description of proposed intervention should be given. Here, all the activities and actions should be recorded and thoroughly explained in their order of occurrence.

• When using drugs, both scientific and brand name should be mentioned followed by the name of the manufacturing company, city, and country. Drug route, dosage, frequency of administration, and total duration of treatment with the drug should be mentioned.
• When using apparatus its name should be given followed by the name of the manufacturer, city and country.

Involved personnel should precisely define:

• Who will be responsible for the interventions?
• What activities each personnel will perform and with what frequency and intensity?

e) Data collection methods, instruments used:

Data collection tools are:

• Retrospective data (medical records) [ 19 ]
• Questionnaires [ 20 ]
• Interviews (Structured, Semi-Structured)
• Laboratory test (literature or personal knowledge should be referenced, if established test, or description should be provided in details, if not established)
• Clinical examinations
• Description of instruments, tools used for data collection, as well as the methods used to test the validity and reliability of the instrument should be provided [ 21 ].

7) Data Management and Analysis Plan: This section should be written following statistical advice from a statistician. The analysis plan and which statistical tests will be used to check the significance to the research question/hypothesis with appropriate references should be described. Names of variables that will be used in the analyses and the name of statistical analysis that will be performed to assess the outcome should be listed [ 22 – 25 ].

If computer programs are to be applied, it is important to mention the software used and its version.

8) Project Management: Work plan-A work plan is an outline of activities of all the phases of the research to be carried out according to an anticipated time schedule.

Proper time table for accomplishing each major step of the study should be defined. Assigning time frame to each step in the trial will be helpful in organizing the structure of the research trial. The personnel (investigators, assistants, laboratory technicians etc.) involved in the study or data collection should be properly trained.

9) Strengths and Limitations: It is important to mention the strengths or limitations of the study, i.e., what study can achieve or cannot achieve is important, so as to prevent wasteful allocation of resources.

10) Ethical Considerations (Issues for Ethical Review and Approvals): It should indicate whether the procedures to be followed are in accord with the Declaration of Helsinki. In any case, study should not start unless approval from ethics committee is received [ 26 ].

The following points should be explained:

• The benefits and risks for the subjects involved. The physical, social and psychological implications of the research.
• Details of the information to be given to the study patients including alternative treatments/approaches.
• Information should be provided on the free informed consent of the participants. Information form should contain: Justification for research, outline of study, risks, confidentiality, and voluntary participation should be told patients about the freedom to withdraw from the study whenever they wish to. Confidentiality indicates how the personal information obtained from the patient will be kept secret (Data safety).

11) Operational Planning and Budgeting (Budget Summary): Outline the budget requirement showing head wise expenditure for the study-manpower, transportation, instruments, laboratory tests, and cost of the drug. Budget estimate is to be attached in the annexure. All costs including personnel, consumables, equipment, supplies, communication, and funds for patients and data processing are all included in the budget. Each item should be justified.

12) Reference System: Referencing is the regular method of recognizing information taken from other researchers’ work. A proper citation will enable the readers to follow-up any reference of interest. Plagiarism refers to claiming and acquiring someone else’s ideas, an action that is considered a criminal action.

Failure to reference an idea that you have found in your research, or to acknowledge the work of other team members in a team assignment falls under the category of plagiarism. Therefore referencing is an extremely important aspect of the research protocol. The two most commonly used citation systems in clinical writing are the Vancouver system and the Harvard system [ 27 , 28 ]. The choice of referencing system is dependent upon the funding organizations where the research protocol is being submitted. These frequently identify their preferred system of referencing and this should be strictly adhered to. The most common style used in the dental literature is Vancouver style.

13) Annexure:

The following annexes are to be attached at the end of the protocol:

• Informed consent form.
• Letters from ethics committees.
• Study questionnaire (copies of any questionnaires or draft questionnaires).
• Case Record Forms (CRFs).
• Budget details.
• Curriculum Vitae (CV) of the chief investigator and co-investigator and their role in the study. It will ensure that the role of each investigator is well defined.

How to Judge A Good Protocol?

The protocol should adequately answer the research question. The research design must be sound enough to yield the expected knowledge. It should provide enough detail (methodology) that can allow another investigator to do the study and arrive at comparable conclusions. Here, the proposed number of participants is reasonably justified and the scientific design is adequately described.

Common Mistakes (Common Pitfalls to Avoid)

Incorporating insufficient elements regarding proposed studies and inadequate explanation for the implication of the problem must be shunned as well as suggesting far more work than can be practically done during the study period. Furthermore, underpowered sample size should be justified, invalid or unreliable instrumentation should be tested and improper statistics should be adequately analyzed.

The most difficult stage of conducting a research project is the preparation of a protocol that results in a short yet comprehensive document that clearly summarizes the project. Such proposal is considered successful when it is clear, free of typographical errors, accurate and easy to read.

It is important to understand the steps in developing a research protocol in order to perform an appropriate study and obtain reliable results. Extra time spent to write a good protocol will save failures at a later stage besides helping analysis. If the protocol is poorly prepared and not adhered to, it is unlikely that the project will yield the information that you hope for and in all probability the chances of selling your idea to the reviewers of a granting agency would be less.

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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.

Common elements of a protocol

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: 

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

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

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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

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.

Where to publish your protocol

There are two main options:

• E.g. Journal of Clinical Epidemiology , Journal of Allied Health , Journal of Clinical Nursing
• 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.

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 . 

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• Last Updated: Sep 11, 2024 11:23 AM
• URL: https://monashhealth.libguides.com/planning_research

How to Write a Research Protocol

• First Online: 15 December 2017

Cite this chapter

• Robert B. Taylor 2  

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A research protocol is the road map you will follow in writing a grant proposal and carrying out your research. This chapter provides a long list of elements that may be included, such as study design, safety considerations, quality assurance, and ethical outcomes. Also included in the chapter are sections on what makes a good research protocol and common problems in research protocols. An early step in your research is securing approval of your Institutional Review Board, and the chapter includes some topics to be included in a cover letter to accompany the protocol.

He who fails to plan, plans to fail. Anonymous

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Taylor, R.B. (2018). How to Write a Research Protocol. In: Medical Writing. Springer, Cham. https://doi.org/10.1007/978-3-319-70126-4_9

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Before You Start Your Research : Writing Protocols

• Health Science Information Consortium
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• Before You Start Your Research

Why write a protocol?

All research should start with a protocol. A protocol is a document that lays out what question you're trying to answer, why it's important, and how you plan to answer it. Creating a protocol is an important step in ensuring that your research is rigorous, ethical, feasible, and reproducible.

A growing number of journals, granting bodies, and research ethics committees require the completion of a protocol prior to beginning your research. Even if you aren't required to draft a protocol, creating a protocol can save you time and resources, reduce research waste, keep you accountable, and ensure that you and your team are adequately prepared.

• Planning a systematic review? Think protocols - BMC Blog
• Public availability of trial protocols

What goes in a protocol?

The specific requirements for a protocol are a little different depending on the type of study that is being planned, and depending on whether the protocol is to be published, registered, or kept as an internal document for the team to work from.

In all cases, writing your protocol is great preparation for your final manuscript. Like a journal article, your protocol should detail your research question, background information on your topic, your data collection and analysis methods, and limitations. Additional information for the protocol may include budget, timelines, and safety and ethical considerations.

Once you've written your protocol, consider publishing or registering it. Doing so allows you to stake your claim on the topic and gives you an additional publication for your CV.

Protocol standards and forms

• PRISMA for systematic review protocols (PRISMA-P)
• Interventional Study Protocol Registration Template - ClinicalTrials.gov - (PDF)
• Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Statement

Protocol writing advice and guidance

• WHO Recommended format for a research protocol
• Systematic Review Protocol template
• Cochrane Interactive Learning Module 2: Writing the review protocol
• A Guide for Developing a Protocol for Conducting Literature Reviews
• Clinical Trial Protocol Development - Clinical Research Resource HUB
• A Guide to Writing and Submitting a BEME (Best Evidence Medical and Health Professional Education) Review Protocol
• Protocol Writing in Clinical Research
• Preparing a Research Protocol to Improve its Chances for Success - Gordon Guyatt

Registering a protocol

• PROSPERO International prospective register of systematic reviews
• Systematic Review Register - Joanna Briggs Institute
• How to Register Your Study - ClinicalTrials.gov
• International Standard Randomised Controlled Trial Number Registry (ISRCTN)
• Registration of a topic/review question - Best Evidence Medical and Health Professional Education
• Start a Registration - Open Science Framework Registries

Why Register?

• Why Should I Register and Submit Results? - ClinicalTrials.gov
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