what is thesis protocol

How to Write a Protocol

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• Raja Kalayarasan 4 &
• Anahita Kate 5  

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WHO | Recommended format for a research protocol [Internet]. Who.int. 2017 [cited 31st July 2017]. http://www.who.int/rpc/research_ethics/format_rp/en/ .

Guidelines for Writing a Research Protocol | ORRP [Internet]. Orrp.osu.edu . 2017 [cited 31st July 2017]. http://orrp.osu.edu/irb/investigator-guidance/exempt.pdf .

Betkerur J. Guidelines for writing a research project synopsis or protocol. Indian J Dermatol Venereol Leprol. 2008;74:687–90.

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Thiese MS. Observational and interventional study design types; an overview. Biochem Med (Zagreb). 2014;24:199–210.

New Delhi: Indian Council of Medical Research; 2006. Ethical Guidelines for Biomedical Research on Human Subjects.

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Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, et al. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010;10(1)

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Department of Surgical Gastroenterology, Jawaharlal Institute of Post Graduate Medical Education and Research, Pondicherry, India

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Cornea and Anterior Segment, L.V. Prasad Eye Institute, Hyderabad, India

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Vikram Kate

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Wyawahare, M., Kalayarasan, R., Kate, A. (2018). How to Write a Protocol. In: Parija, S., Kate, V. (eds) Thesis Writing for Master's and Ph.D. Program. Springer, Singapore. https://doi.org/10.1007/978-981-13-0890-1_6

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How to write a Thesis protocol ?

The first step towards acquiring a post graduate thesis is the writing of a Thesis protocol and the presentation of the same to the research/thesis committee for a critical appraisal. The protocol needs to be corrected according to the suggestions given by the committee. Finally, it needs to be approved by the University. The thesis protocol is then considered an official document and the thesis work needs to conform to the same.

Components of thesis protocol

A. title page, title of thesis.

Title should be informative and relevant. It should preferably one sentence/phrase typed in sentence case. Abbreviations should not be used

What are the types of titles?

1.      Indicative

2.      Informative

3.      Question type

4.      Main or subtitle type

Title page of Thesis protocol contains the following:

Firstly, Name of the University

Secondly, Degree (with discipline) for which the thesis is being submitted

Thirdly, Years of the batch under the name of candidate

Also, Name and Signature of Candidate

Finally Name and Signature(s) of Supervisor and Co-supervisor(s)

Acknowledgements

One should put a page of thanks to those who have helped them in scientific matters and also indirectly by providing such essentials as food, education, genes, money, help, advice, friendship, etc.

Moreover, If any of your work is collaborative, you should make it quite clear who did which sections.

The thesis protocol should be arranged as:

 1. Introduction

 2. Review of literature

 3. Aims and Objectives

 4. Material & Methods

 5. Statistical Analysis

 6. Ethical Consideration

 7. Consent

 8. Information to patients

 9. References

 10. Annexures

 11. Proforma

Introduction/Background

(1-2 pages)

Describe the problem under the consideration (disease or condition) briefly.

Discuss about What is known? & what are gaps?

Summaries briefly the review of literature

Write about research question and its significance

How would answering the research question amend the current knowledge of state?

Conclude introduction section by stating how proposal plans to answer the questions that should be focused, achievable, relevant, and measurable, clear and precise and also justify need for the study (no studies to date have reported outcomes, we examined or evaluation of the results of program was necessary to develop future programs).

The Introduction should answer the questions:

·         What am I studying?

·         Why is it an important question?

·         What do I know about it before I do this study?

·         How will this study help us advance the knowledge?

The structure of introduction section may be thought of as triangle which is inverted (up-side down) –

the broadest part which is on the top representing most general information & focusing down to specific problem one will study. Moreover, Organize the information so as to present more general aspects of the title early in introduction, then the narrow toward more specific current information that provides the context,

finally arriving at the statement of rationale and purpose.Also, Be sure to state clearly the purpose and/or hypothesis that one will investigate.

Finally, It is most customary to place the purpose of statement or hypothesis near the end of introduction, often as topic sentence of final paragraph.

Research Question

1.      Most preferably in question format and not the statement

2.      Focused, precise, and clear

3.      S.M.A.R.T.- Specific, Measurable, Achievable, Relevant, Time format

Review of Literature (ROL)

(3-5 pages)

What is the present knowledge about subject of the study? How the difficulty has been approached by the others and what are the observations? Does the reported studies conflicting? What are the unfilled spaces in the existing knowledge?

1.      Summarize the information about the level of problem under the consideration (disease or condition)

2.      Discuss the related pathology or pathophysiology (do not include the textbook material–very understandable facts)

3.      Review the available studies on the subject or intervention related to the research question. It is nice to provide the summary table of relevant studies where ever necessary

4.      Write the summary of review- What is already known about the subject?

5.      Identify relevant gaps in knowledge

6.       This should ease writing a paragraph on “basis for the study” that should be concluding section of review of literature.

Aims and Objectives:

 Aims refer to what is to be achieved by present study or how the present study would address bigger question or issue

Objectives refer to what would you actually do in the present study.

·         Primary objective refers to the main research question (the primary outcome) and is the base for sample size.

·         Secondary objective refers to the additional questions that are typically for ‘generation of the hypotheses’.

Material and Methods section

  When (….. to …..) and where the study would be carried out.

    Type of study- Prospective/Retrospective

Descriptive or analytical; If analytical, whether observational (cohort, case-control or cross-sectional) or interventional (RCT, cross-over)

Targeted population (Define the subjects of the study)

How would be the subjects chosen; age group, sex– Why being specific?

Any control group (If yes then define)

Sample size: basis of the number of cases

Place where the subjects would be recruited from

The inclusion criteria-Define ages, the criteria for defining the disease condition or normalcyThe exclusion criteria-Subjects who other-wise were eligible for inclusion but are excluded because of the possibility of introducing biasness

Method of Randomization- How the Randomization is done? How the allocation cover up or/and blinding is performed?

Procedure or Intervention

·         Detail if using the new method or quote the standard reference if anyone else has described the method already that you are going to use in your study.

·         Be certain to describe any alterations made of the standard or the published method.

·         Quantitative aspects: masses, incubation times, volumes, concentrations, the machine specifications (include the manufacturer’s name & address)

·         Duration and frequency of intervention

·         Procedures and the schedules of examination or investigations or treatment, and the observation of the outcome measures

  Dosage, schedules, formulations, duration of the drug treatments, if any

Outcome measures (like the union of fracture, birth weight, hemoglobin, etc.)

Follow up of the study participant, if applicable.

If there are multiple measurements, it is great to provide the table with the measurements. Aldo, add the time and tools used for the assessment and procedure for recording or controlling the confounding variable, if any should be mentioned. Standardization of the method and the reference to methodology must be given wherever required.

Statistical analysis:

One should mention the procedure for data entry, statistical methods or software for the statistical analysis, methods for handing the missing data etc.

Level of significance or the level of confidence should also be defined. “A p-value less than 0.05 were considered statistically significant”, since the choice of this cutoff point is arbitrary.

Ethical consideration and the informed consent:

When reporting the experiments on the human subjects, it should be shown whether procedures followed were in agreement with ethical standards on the human experimentation (as per guidelines decided by Central Ethical Committee of the ICMR).

Use Vancouver styling and include the reference that the candidate has accessed and read. Number of references should be limited to 15-20.

Annexures: questionnaires/measurement tools etc.

Patient information sheet & consent form: Both in local and English languages

CERTIFICATE

 I certify that facilities for working on the thesis entitled “xxxxxx” do exist in the department, hospital, laboratory under my/our charge and these shall be provided to candidate for his/her research work in pursuance of his/her plan of thesis. I/We shall guide the candidate in his/her work and shall ensure that the data being included in the thesis are genuine and that the work is being done by the candidate himself.

 (Signature of Supervisor)                           (Signature of Co-supervisor)

   Name and Designation                         Name and Designation

(Signature of Co-supervisor)                                                                                     Name and Designation

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Article Contents

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

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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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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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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.

Financial or Other Competing Interests

The Thesis Process

The thesis is an opportunity to work independently on a research project of your own design and contribute to the scholarly literature in your field. You emerge from the thesis process with a solid understanding of how original research is executed and how to best communicate research results. Many students have gone on to publish their research in academic or professional journals.

To ensure affordability, the per-credit tuition rate for the 8-credit thesis is the same as our regular course tuition. There are no additional fees (regular per-credit graduate tuition x 8 credits).

Below are the steps that you need to follow to fulfill the thesis requirement. Please know that through each step, you will receive guidance and mentorship.

1. Determine Your Thesis Topic and Tentative Question

When you have completed between 24 and 32 credits, you work with your assigned research advisor to narrow down your academic interests to a relevant and manageable thesis topic. Log in to MyDCE , then ALB/ALM Community to schedule an appointment with your assigned research advisor via the Degree Candidate Portal.

Thesis Topic Selection

We’ve put together this guide  to help frame your thinking about thesis topic selection.

Every effort is made to support your research interests that are grounded in your ALM course work, but faculty guidance is not available for all possible projects. Therefore, revision or a change of thesis topic may be necessary.

• The point about topic selection is particularly pertinent to scientific research that is dependent upon laboratory space, project funding, and access to private databases. It is also critical for our candidates in ALM, liberal arts fields (English, government, history, international relations, psychology, etc.) who are required to have Harvard faculty direct their thesis projects. Review Harvard’s course catalog online ( my.harvard.edu ) to be sure that there are faculty teaching courses related to your thesis topic. If not, you’ll need to choose an alternative topic.
• Your topic choice must be a new area of research for you. Thesis work represents thoughtful engagement in new academic scholarship. You cannot re-purpose prior research. If you want to draw or expand upon your own previous scholarship for a small portion of your thesis, you need to obtain the explicit permission of your research advisor and cite the work in both the proposal and thesis. Violations of this policy will be referred to the Administrative Board.

2. Prepare Prework for the Crafting the Thesis Proposal (CTP) Course or Tutorial

The next step in the process is to prepare and submit Prework in order to gain registration approval for the Crafting the Thesis Proposal (CTP) tutorial or course. The Prework process ensures that you have done enough prior reading and thinking about your thesis topic to benefit from the CTP.

The CTP provides an essential onramp to the thesis, mapping critical issues of research design, such as scope, relevance to the field, prior scholarly debate, methodology, and perhaps, metrics for evaluating impact as well as bench-marking. The CTP identifies and works through potential hurdles to successful thesis completion, allowing the thesis project to get off to a good start.

In addition to preparing, submitting, and having your Prework approved, to be eligible for the CTP, you need to be in good standing, have completed a minimum of 32 degree-applicable credits, including the statistics/research methods requirement (if pertinent to your field). You also need to have completed Engaging in Scholarly Conversation (if pertinent to your field). If you were admitted after 9/1/2023 Engaging in Scholarly Conversation (A and B) is required, if admitted before 9/1/2023 this series is encouraged.

Advising Note for Biology, Biotechnology, and Bioengineering and Nanotechnology Candidates : Thesis projects in these fields are designed to support ongoing scientific research happening in Harvard University, other academic institutions, or life science industry labs and usually these are done under the direction of a principal investigator (PI). Hence, you need to have a thesis director approved by your research advisor  prior  to submitting CTP prework. Your CTP prework is then framed by the lab’s research. Schedule an appointment with your research advisor a few months in advance of the CTP prework deadlines in order to discuss potential research projects and thesis director assignment.

CTP Prework is sent to our central email box:  [email protected]  between the following firm deadlines:

• April 1 and June 1 for fall CTP
• September 1 and November 1 for spring CTP.  
• August 1 and October 1 for the three-week January session (ALM sustainability candidates only)
• International students who need a student visa to attend Harvard Summer School should submit their prework on January 1, so they can register for the CTP on March 1 and submit timely I-20 paperwork. See international students guidelines for more information.

Your research advisor will provide feedback on your prework submission to gain CTP registration approval.  If your prework is not approved after 3 submissions, your research advisor cannot approve your CTP registration.  If not approved, you’ll need to take additional time for further revisions, and submit new prework during the next CTP prework submission time period for the following term (if your five-year degree completion deadline allows).

3. Register and Successfully Complete the Crafting the Thesis Proposal Tutorial or Course

Once CTP prework is approved, you register for the Crafting the Thesis Proposal (CTP) course or tutorial as you would any other course. The goal of the CTP is to produce a complete, well-written draft of a proposal containing all of the sections required by your research advisor. Creating an academically strong thesis proposal sets the foundation for a high-quality thesis and helps garner the attention of a well-respected thesis director. The proposal is normally between 15 to 25 pages in length.

The CTP  tutorial  is not a course in the traditional sense. You work independently on your proposal with your research advisor by submitting multiple proposal drafts and scheduling individual appointments. You need to make self-directed progress on the proposal without special prompting from the research advisor. You receive a final grade of SAT or UNSAT (failing grade).

The CTP for sustainability is a three-week course in the traditional sense and you receive a letter grade, and it must be B- or higher to receive degree credit for the course.

You are expected to incorporate all of your research advisor’s feedback and be fully committed to producing an academically strong proposal leading to a thesis worthy of a Harvard degree. If you are unable to take advice from your research advisor, follow directions, or produce an acceptable proposal, you will not pass the CTP.

Successful CTP completion also includes a check on the proper use of sources according to our academic integrity guidelines. Violations of our academic integrity policy will be referred to the Administrative Board.

Maximum of two attempts . If you don’t pass that CTP, you’ll have — if your five-year, degree-completion date allows — just one more attempt to complete the CTP before being required to withdraw from the program. If you fail the CTP just once and have no more time to complete the degree, your candidacy will automatically expire. Please note that a WD grade counts as an attempt.

If by not passing the CTP you fall into poor academic standing, you will need to take additional degree-applicable courses to return to good standing before enrolling in the CTP for your second and final time, only if your five-year, degree-completion date allows. If you have no more time on your five-year clock, you will be required to withdraw.

Human Subjects

If your thesis, regardless of field, will involve the use of human subjects (e.g., interviews, surveys, observations), you will need to have your research vetted by the  Committee on the Use of Human Subjects  (CUHS) of Harvard University. Please review the IRB LIFECYCLE GUIDE located on the CUHS website. Your research advisor will help you prepare a draft copy of the project protocol form that you will need to send to CUHS. The vetting process needs to be started during the CTP tutorial, before a thesis director has been assigned.

4. Thesis Director Assignment and Thesis Registration

We expect you to be registered in thesis soon after CTP completion or within 3 months — no later. You cannot delay. It is critical that once a research project has been approved through the CTP process, the project must commence in a timely fashion to ensure the academic integrity of the thesis process.

Once you (1) successfully complete the CTP and (2) have your proposal officially approved by your research advisor (RA), you move to the thesis director assignment phase. Successful completion of the CTP is not the same as having an officially approved proposal. These are two distinct steps.

If you are a life science student (e.g., biology), your thesis director was identified prior to the CTP, and now you need the thesis director to approve the proposal.

The research advisor places you with a thesis director. Do not approach faculty to ask about directing your thesis.  You may suggest names of any potential thesis directors to your research advisor, who will contact them, if they are eligible/available to direct your thesis, after you have an approved thesis proposal.

When a thesis director has been identified or the thesis proposal has been fully vetted by the preassigned life science thesis director, you will receive a letter of authorization from the Assistant Dean of Academic Programs officially approving your thesis work and providing you with instructions on how to register for the eight-credit Master’s Thesis. The letter will also have a tentative graduation date as well as four mandatory thesis submission dates (see Thesis Timetable below).

Continuous Registration Tip: If you want to maintain continued registration from CTP to thesis, you should meet with your RA prior to prework to settle on a workable topic, submit well-documented prework, work diligently throughout the CTP to produce a high-quality proposal that is ready to be matched with a thesis director as soon as the CTP is complete.

Good academic standing. You must be good academic standing to register for the thesis. If not, you’ll need to complete additional courses to bring your GPA up to the 3.0 minimum prior to registration.

Thesis Timetable

The thesis is a 9 to 12 month project that begins after the Crafting the Thesis Proposal (CTP); when your research advisor has approved your proposal and identified a Thesis Director.

The date for the appointment of your Thesis Director determines the graduation cycle that will be automatically assigned to you:

Once registered in the thesis, we will do a 3-month check-in with you and your thesis director to ensure progress is being made. If your thesis director reports little to no progress, the Dean of Academic Programs reserves the right to issue a thesis not complete (TNC) grade (see Thesis Grading below).

As you can see above, you do not submit your thesis all at once at the end, but in four phases: (1) complete draft to TA, (2) final draft to RA for format review and academic integrity check, (3) format approved draft submitted to TA for grading, and (4) upload your 100% complete graded thesis to ETDs.

Due dates for all phases for your assigned graduation cycle cannot be missed.  You must submit materials by the date indicated by 5 PM EST (even if the date falls on a weekend). If you are late, you will not be able to graduate during your assigned cycle.

If you need additional time to complete your thesis after the date it is due to the Thesis Director (phase 1), you need to formally request an extension (which needs to be approved by your Director) by emailing that petition to:  [email protected] .  The maximum allotted time to write your thesis, including any granted extensions of time is 12 months.

Timing Tip: If you want to graduate in May, you should complete the CTP in the fall term two years prior or, if a sustainability student, in the January session one year prior. For example, to graduate in May 2025:

• Complete the CTP in fall 2023 (or in January 2024, if a sustainability student)
• Be assigned a thesis director (TD) in March/April 2024
• Begin the 9-12 month thesis project with TD
• Submit a complete draft of your thesis to your TD by February 1, 2025
• Follow through with all other submission deadlines (April 1, April 15 and May 1 — see table above)
• Graduate in May 2025

5. Conduct Thesis Research

When registered in the thesis, you work diligently and independently, following the advice of your thesis director, in a consistent, regular manner equivalent to full-time academic work to complete the research by your required timeline.

You are required to produce at least 50 pages of text (not including front matter and appendices). Chapter topics (e.g., introduction, background, methods, findings, conclusion) vary by field.

6. Format Review — Required of all Harvard Graduate Students and Part of Your Graduation Requirements

All ALM thesis projects must written in Microsoft Word and follow a specific Harvard University format. A properly formatted thesis is an explicit degree requirement; you cannot graduate without it.

Your research advisor will complete the format review prior to submitting your thesis to your director for final grading according to the Thesis Timetable (see above).

You must use our Microsoft Word ALM Thesis Template or Microsoft ALM Thesis Template Creative Writing (just for creative writing degree candidates). It has all the mandatory thesis formatting built in. Besides saving you a considerable amount of time as you write your thesis, the preprogrammed form ensures that your submitted thesis meets the mandatory style guidelines for margins, font, title page, table of contents, and chapter headings. If you use the template, format review should go smoothly, if not, a delayed graduation is highly likely.

Format review also includes a check on the proper use of sources according to our academic integrity guidelines. Violations of our academic integrity policy will be referred directly to the Administrative Board.

7. Mandatory Thesis Archiving — Required of all Harvard Graduate Students and Part of Your Graduation Requirements

Once your thesis is finalized, meaning that the required grade has been earned and all edits have been completed, you must upload your thesis to Harvard University’s electronic thesis and dissertation submission system (ETDs). Uploading your thesis ETDs is an explicit degree requirement; you cannot graduate without completing this step.

The thesis project will be sent to several downstream systems:

• Your work will be preserved using Harvard’s digital repository DASH (Digital Access to Scholarship at Harvard).
• Metadata about your work will be sent to HOLLIS (the Harvard Library catalog).
• Your work will be preserved in Harvard Library’s DRS2 (digital preservation repository).

By submitting work through ETDs @ Harvard you will be signing the Harvard Author Agreement. This license does not constrain your rights to publish your work subsequently. You retain all intellectual property rights.

For more information on Harvard’s open access initiatives, we recommend you view the Director of the Office of Scholarly Communication (OSC), Peter Suber’s brief introduction .

Thesis Grading

You need to earn a grade of B- or higher in the thesis. All standard course letter grades are available to your thesis director. If you fail to complete substantial work on the thesis, you will earn a grade of TNC (thesis not complete). If you have already earned two withdrawal grades, the TNC grade will count as a zero in your cumulative GPA.

If you earn a grade below B-, you will need to petition the Administrative Board for permission to attempt the thesis for a second and final time. The petition process is only available if you are in good academic standing and your five-year, degree-completion deadline allows for more time. Your candidacy will automatically expire if you do not successfully complete the thesis by your required deadline.

If approved for a second attempt, you may be required to develop a new proposal on a different topic by re-enrolling in the CTP and being assigned a different thesis director. Tuition for the second attempt is calculated at the current year’s rate.

If by not passing the thesis you fall into poor academic standing, you’ll need to take additional degree-applicable courses to return to good standing before re-engaging with the thesis process for the second and final time. This is only an option if your five-year, degree-completion deadline allows for more time.

The Board only reviews cases in which extenuating circumstances prevented the successful completion of the thesis.

Harvard Division of Continuing Education

The Division of Continuing Education (DCE) at Harvard University is dedicated to bringing rigorous academics and innovative teaching capabilities to those seeking to improve their lives through education. We make Harvard education accessible to lifelong learners from high school to retirement.

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Steps in writing a research protocol for thesis

How to cite this article: Sontakke YA, Bhanarkar UP. Steps in writing a research protocol for thesis. CosmoDerma 2022;2:20.

• INTRODUCTION

Research is an integral part and an important domain of the postgraduate curriculum. The research proposal is a written document proposing a research project in a summarised manner. The question raised in the mind of the researcher at the time of writing a research protocol are “ what are the elements of the research proposal ,” “ what is study problem and rationale, research question and hypothesis ,” “ what are the aims and objectives of the study ,” and “ what are study variables and what is study design .” [ 1 ] If answers to these questions are known, then writing the research proposal can be done with confidence.

During postgraduation, the research protocol writing is required for various purposes such as Institutional Scientific Committee approval, Ethical Committee approval, Animal Ethics Committee approval, for obtaining funds, and for collaboration approval. These committees need a written document to know the problem or issue with a justification of proposed research, the method and novelty of the research, required expenditure, manpower and infrastructure, and the probable benefits and hazards of the research. The components of the research proposal are listed in [ Flowchart 1 ]. [ 1 ]

• ELEMENTS OF RESEARCH PROTOCOL

The title of the research should be informative and interesting. It should be precise, clear, and appropriate. It should reflect the setting or design of the study. [ 2 ]

Background (review of literature): It is a summary of relevant knowledge from the available literature. It should support the question, “ How you have thought for the present study?” The review of literature should be well organized, thorough, and complete, relevant up to date, and logical. It should build the need for the present study, indicate gaps in the existing knowledge, stick to the objective of the study, and be cited with original sources. [ 1 , 3 , 4 ]

Problem statement: The study problem indicates the concerned issues about the health, disease, society, or system. The research problem should be relevant, clear, and logically supported.

Rationale: It is a set of reasons or logical basis of the research study. It is an argument in favor of the implementation of the proposed study. It offers reasons for proceeding to approach the problem with a particular method. The rationale should contain the following facts: “ Why the research is required ( reason) ?” “ What research is required ( objective) ?” “ What results are expected ( result) ?” “ How it will benefit society, patient or science ( benefits) ?” The rationale should support positively the above-mentioned facts and should help to fill the gap in the existing knowledge. [ 5 ]

Novelty: It states the quality of the research study being novel, new, or unique. It refers to one or elements that are new in the research, including new methodology or new observation. Do not exaggerate the novelty mentioning that “it is first study in the world” or so on. [ 1 ]

Research question: It is uncertainty about a problem that can be challenged, examined, and analyzed. It specifies the focus of the study or what is tried to be answered during the study. The research question should meet the FINER criteria that include a feasible, interesting, novel, ethical, and relevant. [ 1 ] The PICOT ( population of interest, interventions, control, outcomes of interest, and time frame ) format is a strategy for framing a research question. [ 1 ] The research question can be expanded by including additional variables such as demographics (gender, age, and so on), demographic location, s ocioeconomic status, s pecificity of condition, and duration. Do not state the implications of the study in the research question. The research question can have a variable list. The research question should be answerable with the help of aims and objectives. [ 6 , 7 ]

Hypothesis: It is a statement about the outcome of the research. It is a prediction that provides an explanation for an observed event. Research hypothesis can be written only if the study has the research question and it is applicable only if there is a measurable result or condition. The hypothesis should be proven correct or incorrect. [ 7 ]

Research aim: It is defined as a broad goal or over-reaching purpose of a research project. The aim is not very specific. It is an achievable goal over an issue.

Research objectives: These are statements that are highly specific, focused, and measurable. There may be one or more research objectives. Objectives are required to avoid the collection of unnecessary data, which are not strictly required to solve the research problem The following words can be used for writing objectives: “ to find, to assess, to identify, to determine, to compare, to calculate, to describe, to analyze, to establish and so on.” [ 7 ]

The research objectives should follow ‘SMART’ protocol: S: specific, M: measurable, A: attainable, R: realistic, T: time-bound. It should be RFLOUM: R: relevant, F: feasible, L: logical, O: observable, U: unequivocal, M: measurable. Objectives should help to fulfill the aim of the study.

• Types of objectives:

Primary objective : It indicates the exact origin of the study and it depends on one or more variable that is derived from the existing lacunae in the literature. Calculation of the sample size mostly depend on the primary objective. It should include investigational setup and variable. [ 1 ]

Secondary objectives : These are additional objectives that can be studied in the due course of time and in the same setup. [ 1 ]

Review of literature: It is essential to initiate the research. It is performed for the following purposes: To find the existing knowledge, to avoid the repetition of the study, to decide the sample size, to find the gap in the existing knowledge, to decide the desirable material and methods, to find earlier confounding factors so that same can be avoided, and so on. It is advised to do the extensive review before submitting the protocol for the approvals. The keywords play an important role in review searches on the internet. Use widely accepted search engines such as PubMed, Scopus, and Google. [ 1 ]

Research methods: It provides the information of a clear and precise description of how the study will be performed. It describes the experimental setting, required materials, list of variables, study design, sampling method, data collection, and analysis method.

Study variables : These are defined as a component that varies in quality or quantity. Variables may be dependent, independent, or confounding variables. The dependent variable is the effect that will be studied and it is a measurable outcome of the study. The independent variable is the core of an experimental study. It can be isolated and manipulated by the researcher. Confounding variables are extraneous variables that interfere with the dependent or independent variables. [ 8 ]

Study design : It is a set of methods or procedures used for collecting and analyzing variables. The study designs may be quantitative or qualitative [ Table 1 ]. [ 1 ]

Subject or sample : The research participants are subjects who got selected for experimental studies by the researcher. The rights of human participants depend on the constitutional laws. The basic rights of participants should be followed that includes proper respect, should be informed, should give written consent, right of privacy of the collected information, to know benefits and demerits of all possible interventions, right to exit the study at any time, right to refuse for the intervention or experimental procedure, to receive all other treatment benefits if he/she refuses participation, should gain the economic benefits against the loss in terms of journey tickets. The participants should not receive any economic benefits just for their participation.

Sample size calculation should be included in material and methods. The reference parameter and reference study utilized for the sample size calculation need to be included. The research proposal should include–exclusion criteria to reduce the effect of confounding factors or research outcomes. [ 1 ] The inclusion criteria are based on the similarity of the properties of the target population such as type and stage of disease, the subject’s previous treatment history, age, sex, race, ethnicity, and so on. Exclusion criteria concern properties of population to be excluded from the current study sample based on either ethical reasons or practical issues or the factors that may lead to biases in the study’s results. [ 1 ] The sample size for any study depends on the acceptable level of significance, power of the study, expected effect size, underlying event rate in the population, and standard deviation in the population. [ 9 ]

A sampling method is a procedure for selecting the sample (participants) that represents the entire population at a given period. The sampling saves the resources and gives results applicable to the population. There may be probability or nonprobability sampling. In probability sampling, each element in the population has an equal, independent chance of being selected. In nonprobability sampling, some elements of the population have no chance of selection or the probability of the selection. [ 10 ]

In random allocation, the selected participant is allocated to study the group on a chance basis. In random allocation, every member of the population has an equal chance of being selected. It helps to maximize the probability that will be comparable. Methods of randomization are drawn from a random number table and are computer-generated. Selection of cases on alternate days or selection of alternate cases is not the method of randomization. [ 11 ]

Data collection : The detailed data collection sheet should include all variables, their measurement units, methods of data collection, and so on. It may include questionnaires for data collection if any.

Data analysis : Research proposal should contain the data analysis procedure. Data analysis mainly depends on the type of data, such as descriptive or analytical data. The descriptive data are expressed as shape, tendency, variability, mean, median, range, and proportion, For analytical data, the association of two or more variables and the strength of association can be assessed. This section should include the list of tests of statistical analysis of the variables and values of inferences. The value of inference includes mean, median, mode, standard deviation, coefficient of variation, degree of freedom, risk, odds ratio, sensitivity, and specificity. The use of the statistical test depends on the sample size and distribution of data, study design, and type of analysis. It should be mentioned at what P -value the level of significance is considered. [ 1 , 12 ]

Ethical considerations: All the research proposals should get through the Institutional Ethics Committee. It mainly focuses on the autonomy and protection of the participant, benefit and risk ratio, the scientific validity of the study, and informed consent. “Legally, children are not able to give informed consent until they turn 18 years.” Before participation in a clinical trial, children are asked for their assent, that is, they should agree to take part. The researcher needs to explain the trial to a child in a language they can understand. As per the ICMR guidelines for children between 7 and 12 years of age, oral assent must be obtained in the presence of the parent/legally acceptable representative. For children between 13 and 18 years of age, written assent must be obtained. If a child turns 13 during the course of the study, then written assent must be obtained.” The level of risk should be mentioned. ICMR classified the risk to the participants into four categories less than minimal risk, minimal risk, low risk, and more than minimal risk. [ 13 ]

Consent forms: It is a written document that provides the relevant information about the ongoing research to the participant. It should explain a clear role, risk benefits to the participant and should be signed by the participant in front of the witness. If the participant is a minor in age, then the consent form should be signed by his/her parent or legal guardian. The consent form should be in the simple and local language, contain the purpose of the study, and the procedure in brief. It should convey a clear message about “ why is this study being done, ” “ what is involved in this study and how long will it take?. ” It should include information about compensation for participation and confidentiality and should mention the right to leave the study at any time. [ 15 ]

Budget: It may be submitted for obtaining a grant. It is a financial proposal that reflects the proposed research. The budget should reflect expenditure toward the personnel (manpower), equipment, travel, overhead charges (for maintenance of institutional infrastructure, telephone, electricity, and equipment). Justification for budget includes proper justification for each segment. While preparing a budget, the yearly increasing costs of the consumable and nonconsumable items should be kept in mind. An intramural grant is a fund provided by the parent institute to faculties to support research and professional development. An extramural grant is a fund provided by external funding agencies for research. [ 15 ]

Registration of clinical trial : The principal investigator has to register all the clinical trials in India at Clinical Trial Registry–India (CTRI) on www.ctri.nic.in before enrolment of the first participant. It is a free and online public record system and is maintained to ensure transparency, accountability, and accessibility of clinical trials. [ 16 ]

References: Citation of existing knowledge is an important component of scientific writing. Vancouver format of referencing is widely accepted. Other reference stylings include Hayward referencing style, American Psychological Association System, and so on. Microsoft office has an inbuilt reference manager which is a very useful tool. Online reference managers are also available such as “zotero.org,” “ https://flowcite.com/reference-manager/ ” and so on. [ 17 ]

Qualities of good research proposal: It should provide sufficient, brief information, has a solid background, clear research question, proper study design, appropriate rationale, suitable and feasible methods, appropriate and adequate sample size, ethically acceptable, financially feasible, and is completed in feasible duration.

Declaration of patient consent

Patient’s consent not required as there are no patients in this study.

Financial support and sponsorship

Conflict of interest.

There are no conflicts of interest.

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