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• How to Write a Research Proposal | Examples & Templates

How to Write a Research Proposal | Examples & Templates

Published on 30 October 2022 by Shona McCombes and Tegan George. Revised on 13 June 2023.

A research proposal describes what you will investigate, why it’s important, and how you will conduct your research.

The format of a research proposal varies between fields, but most proposals will contain at least these elements:

Introduction

Literature review.

• Research design

Reference list

While the sections may vary, the overall objective is always the same. A research proposal serves as a blueprint and guide for your research plan, helping you get organised and feel confident in the path forward you choose to take.

Table of contents

Research proposal purpose, research proposal examples, research design and methods, contribution to knowledge, research schedule, frequently asked questions.

Academics often have to write research proposals to get funding for their projects. As a student, you might have to write a research proposal as part of a grad school application , or prior to starting your thesis or dissertation .

In addition to helping you figure out what your research can look like, a proposal can also serve to demonstrate why your project is worth pursuing to a funder, educational institution, or supervisor.

Research proposal length

The length of a research proposal can vary quite a bit. A bachelor’s or master’s thesis proposal can be just a few pages, while proposals for PhD dissertations or research funding are usually much longer and more detailed. Your supervisor can help you determine the best length for your work.

One trick to get started is to think of your proposal’s structure as a shorter version of your thesis or dissertation , only without the results , conclusion and discussion sections.

Download our research proposal template

Prevent plagiarism, run a free check.

Writing a research proposal can be quite challenging, but a good starting point could be to look at some examples. We’ve included a few for you below.

• Example research proposal #1: ‘A Conceptual Framework for Scheduling Constraint Management’
• Example research proposal #2: ‘ Medical Students as Mediators of Change in Tobacco Use’

Like your dissertation or thesis, the proposal will usually have a title page that includes:

• The proposed title of your project
• Your supervisor’s name
• Your institution and department

The first part of your proposal is the initial pitch for your project. Make sure it succinctly explains what you want to do and why.

Your introduction should:

• Introduce your topic
• Give necessary background and context
• Outline your  problem statement  and research questions

To guide your introduction , include information about:

• Who could have an interest in the topic (e.g., scientists, policymakers)
• How much is already known about the topic
• What is missing from this current knowledge
• What new insights your research will contribute
• Why you believe this research is worth doing

As you get started, it’s important to demonstrate that you’re familiar with the most important research on your topic. A strong literature review  shows your reader that your project has a solid foundation in existing knowledge or theory. It also shows that you’re not simply repeating what other people have already done or said, but rather using existing research as a jumping-off point for your own.

In this section, share exactly how your project will contribute to ongoing conversations in the field by:

• Comparing and contrasting the main theories, methods, and debates
• Examining the strengths and weaknesses of different approaches
• Explaining how will you build on, challenge, or synthesise prior scholarship

Following the literature review, restate your main  objectives . This brings the focus back to your own project. Next, your research design or methodology section will describe your overall approach, and the practical steps you will take to answer your research questions.

To finish your proposal on a strong note, explore the potential implications of your research for your field. Emphasise again what you aim to contribute and why it matters.

For example, your results might have implications for:

• Improving best practices
• Informing policymaking decisions
• Strengthening a theory or model
• Challenging popular or scientific beliefs
• Creating a basis for future research

Last but not least, your research proposal must include correct citations for every source you have used, compiled in a reference list . To create citations quickly and easily, you can use our free APA citation generator .

Some institutions or funders require a detailed timeline of the project, asking you to forecast what you will do at each stage and how long it may take. While not always required, be sure to check the requirements of your project.

Here’s an example schedule to help you get started. You can also download a template at the button below.

Download our research schedule template

If you are applying for research funding, chances are you will have to include a detailed budget. This shows your estimates of how much each part of your project will cost.

Make sure to check what type of costs the funding body will agree to cover. For each item, include:

• Cost : exactly how much money do you need?
• Justification : why is this cost necessary to complete the research?
• Source : how did you calculate the amount?

To determine your budget, think about:

• Travel costs : do you need to go somewhere to collect your data? How will you get there, and how much time will you need? What will you do there (e.g., interviews, archival research)?
• Materials : do you need access to any tools or technologies?
• Help : do you need to hire any research assistants for the project? What will they do, and how much will you pay them?

Once you’ve decided on your research objectives , you need to explain them in your paper, at the end of your problem statement.

Keep your research objectives clear and concise, and use appropriate verbs to accurately convey the work that you will carry out for each one.

I will compare …

A research aim is a broad statement indicating the general purpose of your research project. It should appear in your introduction at the end of your problem statement , before your research objectives.

Research objectives are more specific than your research aim. They indicate the specific ways you’ll address the overarching aim.

A PhD, which is short for philosophiae doctor (doctor of philosophy in Latin), is the highest university degree that can be obtained. In a PhD, students spend 3–5 years writing a dissertation , which aims to make a significant, original contribution to current knowledge.

A PhD is intended to prepare students for a career as a researcher, whether that be in academia, the public sector, or the private sector.

A master’s is a 1- or 2-year graduate degree that can prepare you for a variety of careers.

All master’s involve graduate-level coursework. Some are research-intensive and intend to prepare students for further study in a PhD; these usually require their students to write a master’s thesis . Others focus on professional training for a specific career.

Critical thinking refers to the ability to evaluate information and to be aware of biases or assumptions, including your own.

Like information literacy , it involves evaluating arguments, identifying and solving problems in an objective and systematic way, and clearly communicating your ideas.

Cite this Scribbr article

If you want to cite this source, you can copy and paste the citation or click the ‘Cite this Scribbr article’ button to automatically add the citation to our free Reference Generator.

McCombes, S. & George, T. (2023, June 13). How to Write a Research Proposal | Examples & Templates. Scribbr. Retrieved 14 May 2024, from https://www.scribbr.co.uk/the-research-process/research-proposal-explained/

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Home » How To Write A Research Proposal – Step-by-Step [Template]

How To Write A Research Proposal – Step-by-Step [Template]

Table of Contents

How To Write a Research Proposal

Writing a Research proposal involves several steps to ensure a well-structured and comprehensive document. Here is an explanation of each step:

1. Title and Abstract

• Choose a concise and descriptive title that reflects the essence of your research.
• Write an abstract summarizing your research question, objectives, methodology, and expected outcomes. It should provide a brief overview of your proposal.

2. Introduction:

• Provide an introduction to your research topic, highlighting its significance and relevance.
• Clearly state the research problem or question you aim to address.
• Discuss the background and context of the study, including previous research in the field.

3. Research Objectives

• Outline the specific objectives or aims of your research. These objectives should be clear, achievable, and aligned with the research problem.

4. Literature Review:

• Conduct a comprehensive review of relevant literature and studies related to your research topic.
• Summarize key findings, identify gaps, and highlight how your research will contribute to the existing knowledge.

5. Methodology:

• Describe the research design and methodology you plan to employ to address your research objectives.
• Explain the data collection methods, instruments, and analysis techniques you will use.
• Justify why the chosen methods are appropriate and suitable for your research.

6. Timeline:

• Create a timeline or schedule that outlines the major milestones and activities of your research project.
• Break down the research process into smaller tasks and estimate the time required for each task.

7. Resources:

• Identify the resources needed for your research, such as access to specific databases, equipment, or funding.
• Explain how you will acquire or utilize these resources to carry out your research effectively.

8. Ethical Considerations:

• Discuss any ethical issues that may arise during your research and explain how you plan to address them.
• If your research involves human subjects, explain how you will ensure their informed consent and privacy.

9. Expected Outcomes and Significance:

• Clearly state the expected outcomes or results of your research.
• Highlight the potential impact and significance of your research in advancing knowledge or addressing practical issues.

10. References:

• Provide a list of all the references cited in your proposal, following a consistent citation style (e.g., APA, MLA).

11. Appendices:

• Include any additional supporting materials, such as survey questionnaires, interview guides, or data analysis plans.

Research Proposal Format

The format of a research proposal may vary depending on the specific requirements of the institution or funding agency. However, the following is a commonly used format for a research proposal:

1. Title Page:

• Include the title of your research proposal, your name, your affiliation or institution, and the date.

2. Abstract:

• Provide a brief summary of your research proposal, highlighting the research problem, objectives, methodology, and expected outcomes.

3. Introduction:

• Introduce the research topic and provide background information.
• State the research problem or question you aim to address.
• Explain the significance and relevance of the research.
• Review relevant literature and studies related to your research topic.
• Summarize key findings and identify gaps in the existing knowledge.
• Explain how your research will contribute to filling those gaps.

5. Research Objectives:

• Clearly state the specific objectives or aims of your research.
• Ensure that the objectives are clear, focused, and aligned with the research problem.

6. Methodology:

• Describe the research design and methodology you plan to use.
• Explain the data collection methods, instruments, and analysis techniques.
• Justify why the chosen methods are appropriate for your research.

7. Timeline:

8. Resources:

• Explain how you will acquire or utilize these resources effectively.

9. Ethical Considerations:

• If applicable, explain how you will ensure informed consent and protect the privacy of research participants.

10. Expected Outcomes and Significance:

11. References:

12. Appendices:

Research Proposal Template

Here’s a template for a research proposal:

1. Introduction:

2. Literature Review:

3. Research Objectives:

4. Methodology:

5. Timeline:

6. Resources:

7. Ethical Considerations:

8. Expected Outcomes and Significance:

9. References:

10. Appendices:

Research Proposal Sample

Title: The Impact of Online Education on Student Learning Outcomes: A Comparative Study

1. Introduction

Online education has gained significant prominence in recent years, especially due to the COVID-19 pandemic. This research proposal aims to investigate the impact of online education on student learning outcomes by comparing them with traditional face-to-face instruction. The study will explore various aspects of online education, such as instructional methods, student engagement, and academic performance, to provide insights into the effectiveness of online learning.

2. Objectives

The main objectives of this research are as follows:

• To compare student learning outcomes between online and traditional face-to-face education.
• To examine the factors influencing student engagement in online learning environments.
• To assess the effectiveness of different instructional methods employed in online education.
• To identify challenges and opportunities associated with online education and suggest recommendations for improvement.

3. Methodology

3.1 Study Design

This research will utilize a mixed-methods approach to gather both quantitative and qualitative data. The study will include the following components:

3.2 Participants

The research will involve undergraduate students from two universities, one offering online education and the other providing face-to-face instruction. A total of 500 students (250 from each university) will be selected randomly to participate in the study.

3.3 Data Collection

The research will employ the following data collection methods:

• Quantitative: Pre- and post-assessments will be conducted to measure students’ learning outcomes. Data on student demographics and academic performance will also be collected from university records.
• Qualitative: Focus group discussions and individual interviews will be conducted with students to gather their perceptions and experiences regarding online education.

3.4 Data Analysis

Quantitative data will be analyzed using statistical software, employing descriptive statistics, t-tests, and regression analysis. Qualitative data will be transcribed, coded, and analyzed thematically to identify recurring patterns and themes.

4. Ethical Considerations

The study will adhere to ethical guidelines, ensuring the privacy and confidentiality of participants. Informed consent will be obtained, and participants will have the right to withdraw from the study at any time.

5. Significance and Expected Outcomes

This research will contribute to the existing literature by providing empirical evidence on the impact of online education on student learning outcomes. The findings will help educational institutions and policymakers make informed decisions about incorporating online learning methods and improving the quality of online education. Moreover, the study will identify potential challenges and opportunities related to online education and offer recommendations for enhancing student engagement and overall learning outcomes.

6. Timeline

The proposed research will be conducted over a period of 12 months, including data collection, analysis, and report writing.

The estimated budget for this research includes expenses related to data collection, software licenses, participant compensation, and research assistance. A detailed budget breakdown will be provided in the final research plan.

8. Conclusion

This research proposal aims to investigate the impact of online education on student learning outcomes through a comparative study with traditional face-to-face instruction. By exploring various dimensions of online education, this research will provide valuable insights into the effectiveness and challenges associated with online learning. The findings will contribute to the ongoing discourse on educational practices and help shape future strategies for maximizing student learning outcomes in online education settings.

About the author

Muhammad Hassan

Researcher, Academic Writer, Web developer

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87Chapter 4 Writing your research proposal

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In many ways it’s a reflection of yourself as a researcher and an insight into your proposed work. A poorly written proposal has the ability to wreck a project and embarrass the researcher before it has even begun. Similarly, a well-constructed proposal bodes well for the success of the project and displays the researcher in a good light amongst their peers and supervisors. The research proposal identifies: • What the topic is, both in terms of background and the individual area of interest. • What you plan to accomplish and why it needs doing. • What in particular you are trying to find out, i.e. the research question. • How you will get the answer to your question, i.e. your methodology. • What others will learn from it and why it is worth learning. • How long it will take. • How much money it will cost. Through your research proposal you are attempting to convince potential supporters that your project is worth doing, you are scientifically competent to run it, and are in possession of the necessary management skills to ensure its completion. The proposal concisely describes the key elements of the study process, although in sufficient depth to permit evaluation. It is a stand-alone document that must contain evidence of an answerable question, demonstrate your grasp of the literature, and also clearly show that your methodology is sound. A research time-table is required to demonstrate a realistic appreciation of how the study will progress through time. The research proposal serves many purposes to many different parties. Amongst these purposes, some of the key ones are: • Acting as a route map and timetable for all involved in your project. • Giving a clear overview of your planned work to ensure favourable decision at ethical review. • Gaining funding to carry out your proposed study. • Securing a place to undertake a higher scientific degree. • Being an opportunity to ‘blow your own trumpet’ on paper. Although there are several bodies who will be obliged to see your proposal, there is a reasonable chance it will end up being wider read than this, so a coherent piece of work will reflect well on you.

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Preparation of the Investigator for a Proposal

The research proposal, insights into the reviewer's perspective, conclusions, writing successful research proposals for medical science  .

(Schwinn) Professor of Anesthesiology and Surgery; Associate Professor of Pharmacology/Cancer Biology, Duke University Medical Center; Senior Fellow, Duke Pepper Aging Center.

(DeLong) Associate Professor, Division of Biometry and Medical Informatics, Duke University Medical Center.

(Shafer) Staff Anesthesiologist, Palo Alto VA Health Care System; Associate Professor of Anesthesia, Stanford University.

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Debra A. Schwinn , Elizabeth R. DeLong , Steven L. Shafer; Writing Successful Research Proposals for Medical Science   . Anesthesiology 1998; 88:1660–1666 doi: https://doi.org/10.1097/00000542-199806000-00031

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HIGH-QUALITY research proposals are required to obtain funds for the basic and clinical sciences. In this era of diminishing revenues, the ability to compete successfully for peer-reviewed research money is essential to create and maintain scientific programs. Ideally, the essentials of “grantsmanship” are learned through observation and participation in grant preparation, but the training environment experienced by most physicians typically focuses on clinical skills. Most physicians are never exposed to a research environment and therefore do not learn how to write grants. The result is that many clinical studies, even when designed by skilled clinicians and those that address important clinical questions, often do not compete successfully with proposals written by basic scientists. This creates a perception that clinical studies are not favorably viewed by research review committees. The opposite is probably closer to the truth; research review committees are very keen to fund excellent clinical research. Although greater numbers of researchers with Ph.D. degrees have applied for National Institutes of Health (NIH) grants compared with researchers with M.D. degrees over the last 10 yr, funding rates (percent applications funded) have remained approximately the same for these investigators ( Figure 1 ; 1995 success rates: all degrees, 6,759 [26.8%]; M.D. - Ph.D., 370 [23.1%]; M.D., 1,518 [28.1%]; Ph.D., 4,746 [26.8%]; other degree, 125 [23.1%]).[section]

Figure 1. Overall success rates for NIH funding of scientific applications, 1986 - 1995. No difference in funding rate is observed between applicants holding M.D. versus Ph.D. degrees. As the success rate for first-time applications was 11.3% in 1993, it is apparent that resubmission of a revised application significantly increases the overall chance of having research proposal ultimately funded.[section]

Capable medical researchers ultimately write research proposals for funding by the NIH. Standards of excellence for NIH grants are high (only the top [almost equal to] 20% of grants are funded). Research questions posed must be hypothesis driven; the investigator must be qualified to perform the study; and preliminary evidence should be presented demonstrating that the research is feasible and will answer the questions posed. The goal of this article is to review important elements of successful research proposals, with emphasis on funding sources available to the anesthesiology community. Two important anesthesia-specific organizations exist to support anesthesia research - The Foundation for Anesthesia Education and Research (FAER, an organization under the auspices of the American Society of Anesthesiologists) and the International Anesthesiology Research Society (IARS).

Successful applications for research support from FAER and IARS have many of the characteristics of grants funded by the NIH and other peer-reviewed funding sources. These characteristics include (1) a highly qualified investigator(s);(2) for junior investigators, a mentor with a successful track record in scientific investigation, peer-reviewed funding, and mentorship of fellows and faculty;(3) a supportive academic environment; and (4) a scientifically sound proposal. Each of these characteristics is discussed in the subsequent sections.

Training of the Investigator

One of the most important components of a successful research proposal is a well-trained investigator. Training in clinical anesthesia is not training in research methodology or scientific thinking; it does not prepare an individual for a career in investigation. Although obvious for basic science research, clinical research also requires commitment of a minimum of 1 yr of dedicated training with a good mentor, and more typically 2 - 3 yr in the field of the proposed research. The applicant also needs to demonstrate commitment to a career in investigation. Several years of scientific training is the first demonstration of such commitment. Research proposals must document institutional support for nonclinical time, and the investigator must provide evidence that this time has been used wisely and will continue to be dedicated to the proposed research.

The research proposal must document a track record of productivity by the investigator. This expectation increases as the training and career of the investigator progresses. Fellowship awards do not have an expectation of prior research training, so publications from prior research are not expected. At the fellowship level, outstanding letters of recommendation, undergraduate and medical school performance, and related accomplishments are most important. Because previous training is not required of the fellowship applicant, prior success of the mentor (publications and track record with previous trainees) weighs heavily in the fellowship review. For junior faculty, peer-reviewed publications are expected from the fellowship period. Young Investigator Annoucements (from FAER) and several new IARS awards require several years as a successful junior faculty member, so expectations of demonstrated research success are further increased. The investigator must demonstrate (1) rigorous training, (2) commitment to research, (3) an appropriate career path, and (4) a track record of productive work. None of these are trivial issues, and none can be easily accomplished without making a commitment to research early in the academic career.

The quality of the mentor is another important aspect of awards granted to fellows and junior faculty. Identification of a mentor is explicitly required for FAER and certain junior level NIH grant applications. First and foremost, the mentor must be a successful investigator. Criteria for this include a track record of publication in the area of the proposed research, continued peer-reviewed funding, and a history of successfully training young investigators. Although mentorship is not considered heavily in more senior grant applications, input from a more experienced investigator often remains beneficial throughout one's career (as we can personally attest to). In addition to the mentor, high-quality coinvestigators, collaborators, and consultants also play important roles in strengthening a research proposal.

Environment

Good research is best accomplished in a supportive, cooperative environment. Because of the changing climate of clinical medicine, researchers (both clinical and basic science) face increasing pressure to minimize research time. It is not possible to become a successful investigator in one's spare time. Documentation of adequate nonclinical time for research (not for committee meetings or other unrelated tasks) is essential. Receiving funding at a junior level often enables the department to match funds or to guarantee nonclinical time to the budding investigator. In general, the more non-clinical time available to an investigator, the more competitive the application.

Other important elements of the environment include people, space, and institutional resources. People include mentors, consultants who can help with specific methodologies, statistical support, helpful colleagues, experienced technicians, a clinical research team, and a dedicated chairperson. There must be adequate space for performing the proposed studies, office space for research personnel, and storage space for equipment and supplies. Institutional resources include related departmental and interdepartmental seminar series, a critical mass of investigators in a related area, instrument development and repair shops, and necessary laboratory space and common facilities.

Criteria for a sound research proposal are the same whether the proposal is submitted to NIH, FAER, IARS, or other funding sources. In crafting a proposal, it is essential to consider the perspective of the reviewer; therefore, items of interest to the reviewer are listed after general definition of the grant proposal.

Review committees receive dozens of grants. NIH study sections may review as many as 150 proposals during one session. Typically, only two or three reviewers are assigned to read each grant in detail, but everyone is expected to read each abstract. Hence, the abstract is often one of the most important parts of the research proposal. The abstract should address the significance of the question and the overall topic, state the hypothesis, and point out key preliminary data. Additionally, the abstract should provide a synopsis of methodologies planned. In the end, the reviewer must be convinced that the applicant is uniquely (or ideally) suited to undertake this important study by the end of this concise paragraph.

Body of the Grant

Specific Aims. The specific aims section is critically important in a scientific proposal. It is here that the investigator crystallizes the overall goal of the research and states specific hypotheses.

Beginning with the specific aims, the proposal must be well written and logically organized. A poorly organized grant application is difficult to review, even if the science is otherwise excellent. Typically, the specific aims begin with a short introduction (one paragraph), followed by a formally stated hypothesis. The hypothesis must be answerable by the research methods proposed. Generally, two or three specific aims are outlined with subheadings where appropriate. Organization of the specific aims is often temporal, starting with a proposed mechanism or the first set of studies in a clinical project. In general, the specific aims section should be no longer than one page.

Background and Significance. The background section provides an opportunity to bring reviewers up to date on current research in the area of the proposal. This section should summarize succinctly studies from the literature and related work published by the investigator. The most crucial aspect of the background is to build a case for significance of the proposed research regarding the ultimate clinical application or mechanistic understanding. Ideally, the background section should demonstrate that the current proposal is a logical extension of previous studies in the field and will provide new information and novel insights. In general, the background section should be about one fourth of the length of the grant proposal.

Preliminary Data. Preliminary data provide the opportunity for the investigator to demonstrate his or her ability to perform the proposed research. The goal in presenting preliminary data is to convince the reviewer that the investigator is capable of performing the proposed studies and that the mechanisms proposed are plausible. Good preliminary data support novel (or even unlikely) hypotheses. Each experimental method proposed should be accompanied by preliminary data demonstrating facility and expertise with related preparations. For example, if the investigator proposes using a specific electrophysiologic technique to study an ion channel, evidence demonstrating that this technique has been used by the investigator with other ion channels and a Figure showingresults from pilot experiments on the channel of interest would suffice. In clinical studies, demonstration of a working investigative team and the ability to enroll a given number of patients per week is helpful. Figures or tables help to convey the message in a succinct manner. They also conserve space in the proposal and create a more impressive effect. Although it is best if the applicant has generated his or her own preliminary data, for training awards, preliminary data from the mentor's laboratory is entirely appropriate. An effective way to organize preliminary data is to present it in the same order as the specific aims (e.g., C.1 preliminary data corresponds to A.1 specific aims, C.2 preliminary data corresponds to A.2 specific aims, etc.). Presentation of preliminary data usually takes about one fourth to one third of the length of the grant application.

Methods. The methods are the guts of the research proposal. Unfortunately, many investigators run out of steam by the time they reach the methods, leaving reviewers unconvinced by the proposed methodology. Ideally, the model being investigated should be broken down into simple, logical components, each accompanied by a description of specific experiments/interventions to be performed. The investigator should assume that at least one reviewer is an expert in each method presented. Therefore, enough detail should be provided to convince an expert that the experiment or technique is being performed properly. Methods presented as a list of recipes, requiring the reviewer to guess which method applies to each study, are recipes for disaster. Individual experimental techniques should be state of the art. In addition, approaching a problem from several angles is often helpful. “Lingo” of the field should be avoided; it is very annoying to reviewers to have to look up unexplained abbreviations or to have models alluded to rather than described. For training grants, methods should involve techniques currently being performed in the laboratory of the mentor. An effective way to organize the methods section is to follow the same order as the preliminary data and specific aims sections (e.g., D.1 methods corresponds to C.1 preliminary data and A.1 specific aims, etc.).

The methods sections should include a description of the design, conduct, and analysis of each study being proposed. Common errors in design include lack of specification of primary outcome, lack of randomization or blinding in clinical trials, inadequate justification of sample size, failure to adjust the total study number for expected dropouts/failed experiments or patient refusal, and use of single drug doses or concentrations rather than development of dose - response or concentration - response relations. Common errors in conducting research include lack of confirmation of drug concentrations, inadequate reproducibility of final results, lack of standardization of procedures, inadequate follow-up, incomplete data recording, and overall lack of organization.

Inadequate or inappropriate statistical methods can be a major weakness of a grant proposal. Many investigators feel confident with all aspects of their methods except the statistical section. Because statistical issues underlie the design and analysis strategy for every study, the input of a biostatistician is essential in planning the research and writing the grant application. Statistical considerations include specification of the primary end points that drive power calculations. Common statistical errors in research proposals include lack of sample size/power calculations, treating continuous variables as dichotomous, repeated t tests when a more comprehensive modeling approach should be taken, application of statistical tests that assume normality without verifying assumptions, failure to consider covariate effects, and failure to distinguish between interindividual and intraindividual variability. The investigator should be familiar with the concept of statistical power and be prepared to estimate some of the quantities needed to formulate an alternative hypothesis appropriately. The statistical analysis should be clearly outlined with specific methodology directed toward the hypotheses of the study. A statistical reviewer is unlikely to be convinced by a statement that “appropriate statistical methodology will be used” or by a barrage of nonspecific statistical jargon. At least one full paragraph (and sometimes an entire page) of the research proposal should be devoted to statistical analysis. Often several smaller statistics sections are appropriately included after each method is presented.

Even the best methods have potential problems and weaknesses. It is critical that the methods section discuss potential problems that may be encountered during the study and state how the investigator proposes to deal with these problems creatively. Reviewers tend to be impressed when the investigator presents potential problems that never occurred to them, because it suggests that the investigator is an expert in this area of research. A time line and organizational plan (who will be responsible for what) should also be included in the methods section so the reviewers can determine whether the investigator is being realistic in his or her approach. The methods section is typically one third to one half of the length of the entire grant proposal.

Introduction to Revised Application. Because so few grant applications are funded on their first submission (11.5% in 1993), the new investigator should not be unduly alarmed if his or her application is not funded. When a grant application has been unsuccessful, an investigator should revise the application and reapply, even if the original score was “noncompetitive”(meaning the grant was in the lower 50% of applications). Often the reviewers suggest key changes that will improve the application significantly. When submitting a revised application, an introduction (placed before the specific aims section) is used to discuss how criticisms of the original grant have been addressed in the revised proposal. Because the reviewer's comments are intended to be helpful, it is important to address each concern carefully in the revised proposal (changed text should be highlighted in the revised application by italic, bold, or identifying lines in the margin), with changes outlined in the introduction section. Angry responses to reviewers do not facilitate funding of the revised application. Remember that reviewers usually have a copy of the prior review, and they expect corrections or, when appropriate, an explanation of why you have chosen not to incorporate some suggestions from a prior review. Time taken to revise an application is well spent; as Figure 1 demonstrates, investigators who persist in revising and resubmitting their applications have an increased chance ([almost equal to] 20% with no previous NIH support, [almost equal to] 35% if previously funded) of ultimately being funded.[section]

In writing a research grant, it is helpful to consider the reviewer's perspective. Key features considered by reviewers include significance, approach, and feasibility. It is wise for the investigator to reread his or her application before submission with these features in mind. The NIH recently has published two documents on-line that discuss review criteria; examination of these documents before submission of a research proposal may prove helpful. These include the Report of the Committee on Rating Grant Applications[double vertical bar] and Review Criteria for Rating Unsolicited Research Grants.#

Significance

First and foremost, is the investigator asking an important question? There are two general ways research studies can be significant. The first is to demonstrate clinical significance. The litmus test for clinical significance is whether the proposed research will improve patient care. The second is elucidation of fundamental mechanisms underlying disease or biologic processes. The ideal research question succeeds in being significant in both areas.

The reviewer assesses whether the research plan can support or refute the stated hypothesis. In addition, the reviewer assesses whether the methodologies used provide adequate or, better yet, elegant approaches to the problem. Recently, the NIH has mandated an increasing emphasis on innovation in research. [1] **

Review committees generally are composed of individuals with expertise in many scientific areas. Additionally, study sections often retain outside reviewers with expertise in the proposed research area. The investigator should assume that his or her methods will be critiqued by at least one expert. Therefore, the investigator should not propose a method that would strike the world's expert in the field as being simplistic, inappropriate, or nonsensical, because the world's expert just might be one of the reviewers. Conversely, some reviewers do not have expertise in the proposed area of research. To ensure that the nonexpert is convinced of the validity and importance of proposed methodologies, the overall proposal should be written with a logical flow of ideas that build from basic to sophisticated concepts. Beginning each portion of the methods section with a short introduction for the nonexpert, followed by a more detailed description of the proposed methods, is an effective strategy to address the needs of both expert and nonexpert reviewers.

Feasibility

The investigator must convince reviewers that the chosen approach is feasible. Preliminary data provide the best demonstration of feasibility. Feasibility is often demonstrated by a track record of publications or peer-reviewed grant support for the applicant or mentor using the proposed experimental approach. Feasibility also can be demonstrated by appropriate statistical analysis of the proposal. For example, a power analysis and corresponding data on the number of patients with the required characteristics at the investigator's institution helps convince reviewers that a clinical study is feasible.

Anesthesiology Funding Sources

Funding for research performed by anesthesiologists is available from many sources. Because the discipline of anesthesiology overlaps many other fields, anesthesiologists have the opportunity to apply for research funds from agencies as diverse as the American Academy of Pediatrics, American Cancer Society, American Heart Association (national and local), American Thoracic Society, American Society for Regional Anesthesiology, critical care societies, Department of Veterans Affairs, National Science Foundation, Shriners, Society for Cardiovascular Anesthesiology, Society for Obstetrics and Perinatology, National Aeronautics and Space Aviation, NIH, and many other private foundations. Grants from FAER and IARS are available specifically to the anesthesiology community.

It is important that anesthesiologists continue to apply for NIH grants. For fiscal year 1996, the NIH awarded 149 research grants (including career development grants, R29, R01, and program project grants) to departments of anesthesiology, totaling $21 million in direct costs ([almost equal to]$31 million in total costs). Because of the diversity of research projects in anesthesiology, these grants were awarded by 14 different institutes, centers, and divisions within the NIH. In analyzing data for three recent review sessions (June 1996, October 1996, and February 1997) from the surgery, anesthesiology, and trauma study section, 26% of anesthesiology applications scored in the top 20th percentile, and 31% scored in the top 25th percentile; clearly no bias exists against anesthesiology in this predominantly surgical study section, at least in this limited sample (Alison Cole, anesthesiology representative for the National Institute of General Medicine Science at the NIH, personal communication, December, 1997). Table 1  

Table 1. Number of Recipients of NIH Research Project Annoucements  

A brief list of funding opportunities available to anesthesiologists early in their career is shown in Table 2 . Several sites are available on the World Wide Web ( Table 3 ) to facilitate access to grant/training resources for anesthesiologists. We have created an additional website ( http://pkpd.icon.palo-alto.med.va.gov/grants/grants.htm ), which provides access to more comprehensive lists of funding agencies and direct links to funding sources. This website also contains example grants designed to illustrate the grant writing principles discussed in this article.

Table 2. Potential Funding Sources  

Table 3. Grant/Training Resources on the WWW  

Successful grant applications require a well-trained investigator who carefully outlines a hypothesis-driven research proposal. Unique to FAER and IARS research committees is that the reviewers are mostly investigators and practicing anesthesiologists. These reviewers fully appreciate the importance of clinical research and enthusiastically support high-quality clinical studies. Although descriptive clinical studies are interesting to practicing clinicians, from a scientific perspective, clinical research must be driven by testable hypotheses. Without a testable hypothesis, clinical research cannot pass the test of adequate significance required for funding.

It is our hope that by demystifying the grant writing and review process that more anesthesiologists will be encouraged to submit proposals for research funding. As part of this effort, we strongly encourage residents and fellows interested in research careers to obtain adequate research training and to apply for appropriate fellowship/junior faculty awards early in their careers.

[section] NIH Extramural Data and Trends, Fiscal Years 1986 - 1995. Bethesda, Office of Reports and Analysis (component of the Office of Extramural Research), National Institutes of Health. (Published on-line and periodically updated. http://www.nih.gov/grants/award/award.htm ).

[double vertical bar] Report of the Committee on Rating Grant Applications. Revised 5/17/96. Bethesda, National Institutes of Health. (Published on-line. http://www.nih.gov/grants/peer/rga.pdf ).

# Review Criteria for Rating Unsolicited Research Grants. NIH Guide, Vol. 26, No. 22, 6/27/97. Bethesda, National Institutes of Health. (Published on-line. http://www.nih.gov/grants/guide/1997/97.06.27/notice-review-criter9.html ).

** Brown KS: A winning strategy for grant application: Focus on impact. The Scientist 1997; April 8:13–4

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How to Write a Research Proposal

The research proposal describes the objective(s), design, methodology, statistical considerations, and organization of a research study; it also gives the background and reason the trial is being conducted. The proposal describes, among other things, what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study.

It is important to remember that writing and developing an effective research proposal takes time. The process starts by identifying the area of research and then developing a focused research question to be answered. It is also important to carefully read over the guidelines of whatever agency you are submitting it to, if applicable, to ensure that the information they require is presented in a clear and complete format for review.

Click on any of the sections below to find a number of resources provided to assist you in the process of formatting an effective research proposal:

Writing a research proposal: the critical first step for successful clinical research

• PMID: 7981258

The proposal is a key element in the thesis or clinical research project. It identifies what is to be studied, why the topic is relevant, and how the research will be conducted. The proposal is a detailed plan or "blueprint" for the intended study, and once it is completed, the research project should flow smoothly. Writing a proposal may seem like a daunting undertaking, but a little thought and preparation will make it easier. In this article, the author provides a sample research proposal and a set of instructions that the beginning researcher should find helpful.

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Writing your research proposal

When applying to study for a PhD or MPhil in the School of Psychology and Clinical Language Sciences, you will typically need to send us an initial 500-word research proposal.

The content and structure of your research proposal will be influenced by the nature of the project you wish to pursue. The guidance and suggested headings provided here should help you to structure and present your ideas clearly.

Your initial research proposal

When writing your initial research proposal, you can either address it to the School generally, or to a specific supervisor if you have one in mind. 

Potential supervisors in the School will review your initial research proposal, and get in touch with you to discuss it. Your proposal may change following this conversation. Depending on the supervisor and the outcome of this discussion, you may be asked to produce a longer research proposal of between 2,000 and 4,000 words.

Tips on writing a research proposal

Before you write your research proposal, we strongly recommend that you check our  research page  and  individual supervisor profiles  to view our areas of expertise.

• You should avoid the use of overly long sentences and technical jargon.
• It is important that the proposed research is realistic and feasible so that the outcomes can be achieved within the scale of a typical research degree programme. This is usually three years full-time for a PhD (or two years for an MPhil). 
• A strong research proposal can and should make a positive first impression about your potential to become a good researcher. It should demonstrate that your ideas are focused, interesting and realistic.

Although you should write your proposal yourself, it is best if you discuss its contents with your proposed supervisor before you submit it. If this is not possible, then try to get someone else (such as an academic at your current or previous institution) to read and comment on it to ensure that it is sufficiently clear.

Your proposal needs a clear working title that gives an indication of what you want to study. You are not committed to continuing with the same title once you begin your studies.

Research question

For many projects, you'll usually address one main question, which can sometimes be broken down into several sub-questions. However, it's OK to have two or three research questions where appropriate.

In your research proposal, you'll need to state your main research question(s), explain its significance, and locate it within the relevant literature, in order to set out the context into which your research will fit. You should only refer to research that is directly relevant to your proposal. 

Questions to address in your research proposal

You will need to address questions such as:

• What is the general area in which you will be working, and the specific aspect(s) of that area that will be your focus of inquiry?
• What is the problem, shortcoming, or gap in this area that you would like to address?
• What is the main research question or aim that you want to address?
• What are the specific objectives for the proposed research that follow from this?
• Why is the proposed research significant, why does it matter (either theoretically or practically), and why does it excite you?
• How does your work relate to other relevant research in the department?

Methodology

You will need to explain how you will go about answering your question (or achieving your aim), and why you will use your intended approach to address the question/aim. 

Questions you might need to address include:

• What steps will you take and what methods will you use to address your question? For instance, do you plan to use quantitative or qualitative methods?
• How will your proposed method provide a reliable answer to your question?
• What sources or data will you use?
• If your project involves an experimental approach, what specific hypothesis or hypotheses will you address?
• What specific techniques will you use to test the hypothesis? For example, laboratory procedures, interviews, questionnaires, modelling, simulation, text analysis, use of secondary data sources.
• What practical considerations are there? For example, what equipment, facilities, and other resources will be required?
• What relevant skills and experience do you have with the proposed methods?
• Will you need to collaborate with other researchers and organisations?
• Are there particular ethical issues that will need to be considered (for example, all projects using human participants require ethical approval)?
• Are there any potential problems or difficulties that you foresee (for example, delays in gaining access to special populations or materials) that might affect your rate of progress?

You will need to provide a rough timeline for the completion of your research to show that the project is achievable (given the facilities and resources required) in no more than three years of full-time study (or part-time equivalent) for a PhD, and two years for an MPhil.

Expected outcomes

You need to say something about what the expected outcomes of your project would be.

How, for example, does it make a contribution to knowledge? How does it advance theoretical understanding? How might it contribute to policy or practice?

If you are aiming to study for a PhD, then you need to say how your proposed research will make an original contribution to knowledge. This is not essential if you are aiming to study for an MPhil, although you will still need to show originality in the application of knowledge.

List of references

You will need to provide a list of any key articles or texts that you have referred to in your proposal.

References should be listed in the appropriate style for your subject area (e.g. Harvard). You should only reference texts that you think are central to your proposed work, rather than a bibliography listing everything written on the subject. 

Format and proofreading

Make sure that your proposal is well structured and clearly written. It is important that you carefully check your proposal for typographical and spelling errors, consistency of style, and accuracy of references, before submitting it.

The proposal should be aesthetically well presented, and look professional (e.g. no font inconsistencies, headings clearly identifiable). If you include figures, then they should be accompanied by captions underneath).

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Research/Clinical/Student Project Proposal Guidelines

Download the 2016 application.  All materials must be formatted using APA format.

I. Quantitative Research Proposal

1. Title and Abstract A 200-word abstract are to accompany the proposal. The abstract should include the study aim, significance, the population and sample description and a statement of the design and analysis.

2. Proposal Outline (1,500 word limit) The following areas are to be included in the proposal, as appropriate.

A. The Problem a) Statement of the problem or research question. b) Hypotheses. c) Definitions of variables. Theoretical and operational definitions (instruments). d) Theoretical framework and population. e) Critique of the most salient elements of the pertinent literature. f) Significance to nursing science.

B. Methodology a) Design b) Instrument reliability and validity. c) Data collection procedure. Include official human subjects reviews if conducted and a consent form. d) Sample, size and sampling procedure. e) Method of analysis.

C. References and Appendices a) Reference list

II. Qualitative Research Proposal

A. Title and 200-word Abstract

B. Proposal (1,500 word limit)     a) A clear statement that specifies the phenomenon to be studied;     b) Documentation of a need for study and significance of the study for nursing;     c) Identification of the qualitative approach with a rationale for its selection;     d) Specification of the design with attention to:         - what data are sought         - how and when those data will be solicited         - how relationships with research participants will be initiated, maintained and terminated         - how data will be managed         - how data will be analyzed and related to pre-existing knowledge         - how findings will be reported     e) References and Appendices

III. Clinical Project – 1500 word limit A clinical project is defined as a professional nursing project that addresses a common or significant health concern in a creative and evidence-based manner.  The project should go beyond the applicant’s usual academic or employment requirements. 

A. Aims - State clearly the clinical significance of the project including how it will identify/test/demonstrate nursing interventions and/or care delivery models that provide the most beneficial outcomes for patients. State concisely and realistically the expected clinical impact of this project, i.e., what the clinical project is intended to accomplish and/or demonstrate. 

B. Significance & Background - Briefly describe the clinical significance of the project. Be clear what is being demonstrated. Provide a synthesis of the literature in the field(s) that is pertinent to the proposed project. Summarize the rationale or theoretical/conceptual underpinnings for the work. State clearly the relationship of this project to an overall program of clinical scholarship.

C. Method - Discuss in detail the methods to be used to accomplish the aims. Describe the potential limitations of the methods and approaches you will use to minimize these limitations. Delineate measures to be used to assess the effect of the project.

D. Dissemination & Translation – Describe the audiences that would benefit from knowing and adopting the findings of this work. Outline a dissemination plan.

E. Time Frame - Provide a timeline for the main steps of the project, including anticipated start and completion dates. 

IV. Student Project – 1500 word limit A student project is defined as project that addresses a common or significant health concern in a creative and evidence-based manner. It may include activities associated with Masters, PhD or DNP work.

A. Aims - State clearly the clinical or research significance of the project including how it will identify/test/demonstrate nursing interventions and/or care delivery models that provide the most beneficial outcomes for patients. State concisely and realistically the expected clinical impact of this project, i.e., what the clinical project is intended to accomplish and/or demonstrate. 

B. Significance & Background - Briefly describe the clinical or research significance of the project. Be clear what is being demonstrated. Provide a synthesis of the literature in the field(s) that is pertinent to the proposed project. Summarize the rationale or theoretical/conceptual underpinnings for the work. State clearly the relationship of this project to an overall program of scholarship. 

C. Method - Discuss in detail the methods to be used to accomplish the aims. Describe the potential limitations of the methods and approaches you will use to minimize these limitations. Delineate measures to be used to assess the effect of the project. 

E. Time Frame - Provide a timeline for the main steps of the project, including anticipated start and completion dates.

UCL Doctorate In Clinical Psychology

Guidelines for the Research Proposal

The purpose of the research proposal is to help you organise your ideas about your major research project, and to enable you to get feedback on what you are planning to do. It is worth putting in careful thought at this stage: it will mean that the project is more likely to run smoothly in the long run, and much of what you write in it can eventually be recycled into the final thesis write-up. The proposal is also needed for NHS ethics applications.

The proposal is a course requirement, but is not an assessed piece of work. It is due early in Term 1 of Year 2 (the date will be announced). Please submit an electronic copy to the Research Administrator (following the procedure detailed on the Project Support Moodle site).

There is no formal word limit (but conciseness is essential): we suggest that you aim for around 2500 words, plus references and any necessary appendices. Format it double-spaced, and include page numbers so that reviewers can easily refer back to specific points. Since it is not assessed work, it does not need your code number; please put your name on it.

Some sample proposals from previous years are available on the 'Proposal' (Topic 4) section of the Research Project Support Moodle. 

The structure and content of the proposal is similar to that of the introduction and method sections of a journal article:

A title page with (1) the provisional title of the project (this can be modified later on), (2) your name, (3) your internal and external supervisors, (4) the setting where the study is likely to take place and (5) the date. If you are doing a joint project with other trainees, this should be stated here and the other trainees should be named. (Including all of this information on the title page is very helpful for the course's administrative purposes.)

The introduction (3 or 4 pages) states what the research topic is and why it is important. It succinctly reviews previous research in the area and relevant psychological theory, and summarises the rationale for the intended study. The introduction should end with one or more clearly stated research questions or hypotheses.

The method section (3 or 4 pages) describes in detail the proposed research methods: the setting, participants, sample size, research design, measures, ethical considerations, and data analysis procedures. For quantitative research, the sample size needs to be determined by a power calculation, which should be reported here (a separate document on power calculations is on the Project Support Moodle site). Measures that are not well known should be included as an appendix. For qualitative research, describe your interview schedule (append a draft) and your proposed method of analysis, including the types of "credibility checks" that you propose to use.

The service user involvement section (one or two or paragraphs) describes how the needs and views of service users or other relevant members of the public have shaped or will shape your project. This could include examples of service users influencing: (1) the choice of topic to be researched; (2) decisions about methodology; (3) the design of materials such as invitation letters and participant information sheets; (4) the design of a qualitative interview schedule, and (5) the ethics of the research. Please outline any plans for service user involvement later in the project.  Remember, whilst there are formal ways of eliciting service user views, such as the use of focus groups and services such as FAST-R ( Feasibility And Support to Timely recruitment for Research ), informal sources of information are also valuable, and can be described here. This might include conversations with individual service users, experiences from clinical work, or interactions that take place on-line.

Whilst we strongly encourage trainees to use service user input when developing their research, this is not obligatory. Sometimes consultation with service users and other members of the public is not necessary, for example in some studies of healthy volunteers. If there has been no input from service users or members of the public, please use this section to state this, and briefly (a couple of sentences) explain why. 

The feasibility section has a brief appraisal of how realistic your project is in practical terms, particularly with regard to recruiting participants. Many trainees (and their supervisors!) tend to be over-optimistic at this stage of the project, and it is a good idea to address potential recruitment problems at the outset. You should also include a fallback plan in case things go pear-shaped (which, sadly, in clinical research they often do). It would be helpful if you provided an estimate of what the smallest viable sample size would be, so that we (and you) have an idea of what a worst-case scenario might look like. A general timetable for the project is given in the guidelines for the major research project . If you anticipate any major departures from this, give details and a rationale.

The joint working section is, of course, only required if you are proposing a joint project. In this section provide a brief outline of what your anticipated contribution to the overall study will be, and what will be done by others. There should be a statement of how your research question(s) and analyses will be distinct from those of other students involved in the project. It will be helpful to consult the course guidelines on joint projects when planning any joint study. 

The institutional arrangements , e.g., the setting, and who has agreed to be your internal and external supervisors.

The costings section sets out any substantial expenses that the project may entail. Note that the Department has limited funds and does not normally fund projects costing more than £250 over two years (see the course document on research funding ). If your project is likely to cost more than this,  the course may possibly  be able to provide some additional funding up to £400, although this cannot be guaranteed. It is your responsibility to secure additional funding for expenses beyond that allocated by the course.

The reference list gives all cited works. (It is important to check that this is complete, because reviewers may consult some of your references to understand the background to your study.)

Appendices include measures not in common use, draft qualitative interview schedules, etc.

Supervisors' input

Research proposals usually need to go through several drafts. Show your internal and external supervisors a draft early enough so that you can incorporate their comments into a revised draft before submission.

Review of the proposal

The proposal will be read by one of the academic staff, and will be discussed at a proposals review meeting in October. The resultant written feedback that you receive (towards the end of October) will give you a clear indication of the general feasibility of your project, and suggest any changes that will need to be made before it goes ahead. 

This process counts as the "peer review" that is required for all NHS ethics applications. Therefore, once your proposal has passed the review stage, those of you applying for NHS ethics should contact Will Mandy to ask for a letter confirming that your project has been successfully peer reviewed.  

Printable version of this page

• Policy & Compliance
• Clinical Trials
• Protocol Templates For Clinical Trials

Protocol Templates for Clinical Trials

NIH applicants can use a template with instructional and sample text to help write clinical protocols for the following types of research:

• Phase 2 or 3 clinical trials that require Investigational New Drug applications (IND) or Investigational Device Exemption (IDE) applications
• Behavioral and social sciences research involving humans

These clinical protocol templates can be accessed via the secure web-based e-Protocol Writing Tool and as Word templates  

• enables participation for multiple writers and reviewers
• allows assignments for writers and collaborators
• tracks progress and ensure document version control

Word Templates

Related notices.

NOT-OD-17-064 NIH and FDA Release Protocol Template for Phase 2 and 3 IND/IDE Clinical Trials

• NOT-OD-19-092 NIH Releases Protocol Template for Behavioral and Social Sciences Research Involving Humans

This page last updated on: July 12, 2021

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NCCIH Research Blog

Targeting and developing your clinical research proposal.

May 4, 2018

Wendy J. Weber , N.D., Ph.D., M.P.H.

Branch Chief

Clinical Research in Complementary and Integrative Health Branch

National Center for Complementary and Integrative Health

View biographical sketch

If you’re planning to apply for an NCCIH grant for research involving human participants and will be attending the International Congress on Integrative Medicine and Health (ICIMH) , this Pre-Congress Workshop may be for you: “Honing Your Clinical Research Proposal for NIH and NCCIH Funding Opportunities.” It’s scheduled for Tuesday, May 8 from 2 to 5 p.m.

The symposium will cover NCCIH’s human subjects research priorities, available funding opportunities available, and review the significant recent changes to the National Institutes of Health’s (NIH) clinical trial policies, application forms, and review criteria. (Blog posts about those changes were published in May and September , 2017.)

Speakers will include:

• Dr. Emmeline Edwards, Director of NCCIH’s Division of Extramural Research (DER), will provide an overview of NCCIH’s strategic priorities for human subjects research.
• Dr. Wendy Weber, Acting Deputy Director of NCCIH and Chief of the Clinical Research in Complementary and Integrative Health Branch in the Center’s Division of Extramural Research (DER) will speak on NIH’s recent policy changes for clinical trials.
• Dr. Dave Clark, a program director in NCCIH’s Clinical Research Branch, will talk about NCCIH research funding opportunities focused on clinical outcomes.
• Dr. Wen Chen, NCCIH’s Acting Branch Chief for Basic and Mechanistic Research, will talk about NCCIH’s mechanism-focused clinical research funding opportunities.
• Dr. Martina Schmidt, Chief of NCCIH’s Office of Scientific Review, will explain the changes in NIH’s grant application forms and how they affect the review process.

After the presentations, participants will split into small groups for discussion and Q&A on how to interact with NCCIH staff to find the best funding opportunity for the research you want to conduct, how to shape your aims to be responsive to NCCIH funding opportunities, and what to include in your application to address the review criteria. Small group themes will be (1) clinical outcomes research and (2) human basic and mechanistic research.

We hope you will join us! We think you’ll find this session very informative, and the panelists look forward to answering your questions.

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• CREd Library , Research Design and Method

Clinical Trials Concept Proposal: Thirty-One Essential Elements

Gordon b. hughes.

• March, 2013

DOI: 10.1044/cred-gsd-ps-cpri004

Presented at the Clinical Practice Research Institute (CPRI). Hosted by the American Speech-Language-Hearing Association Research Mentoring Network.

Essential Elements

1. List the title of the proposed research, the Principal Investigator(s), and the institution(s).

2. If prior clinical trial experience is minimal, appoint clinical trial expert(s) as key personnel to help with study design and execution.

3. Appoint a biostatistician, preferably with clinical trial experience, as key personnel.

4. Describe the target disease, primary study objective, and any secondary objectives.

5. Briefly describe the scientific rationale for the study. State the compelling public health need and the trial’s potential impact on medical care.

6. Briefly describe the study design and indicate, in general terms, how the design will fulfill the intent of the study. For a preliminary phase I or II clinical trial, describe how it will be used to formulate a definitive phase III clinical trial.

7. Applications require compelling preliminary data. Are preliminary data adequate?

8. Describe the informed consent process and human subjects protections. If risks are minimal, describe a data safety plan. Describe how adverse events will be reported.

9. If risk is more than minimal, appoint an independent Medical Officer to help manage adverse events. Is Data Safety Monitoring Board required? Describe a detailed adverse event reporting plan.

10. If risk is more than minimal, describe an interim monitoring plan, including the schedule of interim analyses and stopping rules for safety.

11. Consider ethical considerations of the proposed research. For example, placebo-controlled trials may be unethical if standard-of-care treatment exists.

12. List specific inclusion and exclusion criteria. How will these criteria impact on subject recruitment and retention? Describe the method for identifying and recruiting subjects.

13. Describe the number of subjects to be enrolled, and the number of clinical sites needed to meet target enrollment.

14. Describe the statistical and clinical basis for the sample size calculation.

15. Describe the extent and type of blinding/masking. If possible, persons measuring the primary outcome should be masked.

16. Describe the randomization procedure.

17. Describe how the intervention will be administered, including dose and duration as applicable.

18. How will fidelity checks be used to insure that each subject receives the correct treatment?

19. Describe the primary and secondary outcomes and how they will be measured. Only one primary outcome measure at one endpoint is permitted; all other measurements are observational.

20. List the statistical methods to be used to analyze these outcomes. Specify whether an intention-to-treat analysis will be performed.

21. Explain how missing data, outliers, noncompliance and losses to follow-up will be handled in the analysis.

22. Describe how data will be handled and stored. How will data integrity and confidentiality at individual sites be confirmed? Double-blind trials require an independent Data Coordinating Center.

23. Specify stopping rules for efficacy, futility, or poor study performance. For phase I and II trials, specify an efficacy threshold needed to progress to a phase II or III trial.

24. Do not underestimate trial duration. Allow ample time for start-up, planned enrollment, follow-up to endpoint, and close-out.

25. Do not underestimate trial cost. For phase II and III trials, budget for a Clinical Coordinating Center, Data Coordinating Center, and Data Safety Monitoring Board as needed.

26. For a new drug or device, try to obtain an IND, IDE or written waiver from the FDA before submitting the application. Letters of Approval can be sent after submission, and will be included in review if received thirty days in advance.

27. Name the participating pharmaceutical or device manufacturing company, if any.

28. Do you or any member of your Study Team have a financial conflict of interest or hold a patent for the use of the intervention in this protocol?

29. For phase II or III trials, have you considered collaborating with an NIDCD clinical research network such as CHEER?

30. Estimate direct costs for all years of funding. Notify the Program Officer thirty days before submission if you are requesting $500,000 direct costs in any year.

31. Indicate a planned submission date.

Further Reading: Sample of NIDCD Clinical Trials

National Institute on Deafness and Other Communication Disorders (NIDCD). (2012). Clinical Trials: Information for Researchers and Health Professionals . NIDCD: Research: Clinical Studies: Clinical Trials (Available from the NICDC Website at http://www.nidcd.nih.gov/).

Gordon B. Hughes National Institute on Deafness and Other Communication Disorders, NIH

Copyrighted Material. Reproduced by the American Speech-Language-Hearing Association in the Clinical Research Education Library with permission from the author or presenter.

Clinical Research Education

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Clinical Research Proposal

In the time when the sea was the avenue through which a nation can conquer the world, Britain believed that a strong naval fleet of almost 2,000 men could make a dent out of Spain’s stronghold in America. After surviving the storms and long days at sea, the people did not expect that they would fall prey to a silent killer amongst them. Sailors had been dying from the most common maritime disease that had claimed the lives of countless others—scurvy. It was only later learned that the disease could be cured with citrus fruits, thanks to the physician James Lind. Years after the treatment for scurvy was available, Britain became a naval superpower, and the English language started to be introduced to the rest of the world. Lind’s observation was the first of many clinical research that changed the world.

7+ Clinical Research Proposal Templates and Samples

However revolutionary, there are downsides to fresh fruits as the go-to cure for the disease. Citrus fruits generally do not last long, especially then when there was no refrigerator nor electricity. The extract contains a volatile compound in its natural form. Heat and long periods of storage destroy the therapeutic activity of the substance, and the compound itself. It was much later that vitamin C was synthetically produced as tablets and capsules. Before a drug reaches the patients, it undergoes a series of tests and clinical trials that ensure that the drug is safe and significantly effective. Clinical research deals with treatments and services for the benefit of society. Clinical researchers are working on several treatment and prevention options to improve and advance medicine and human health. Their revolutionary ideas start with a research proposal for succeeding tests and validations.

1. Research Proposal Template

• Google Docs

Size: A4 & US Letter Sizes

Clinical research covers studies that deal with the improvement of health products and services. Each study proposes news or reviews the effect of the present method or product aimed to better the health quality of people. For the research to proceed to the testing for efficacy and safety for human consumption, researchers first have to convince a board or committee concerned that the study is worth pursuing. The research proposal should sway the respective authority to approve and support the activity. It should show that you are competent and capable of conducting the desired research undertaking. To help you in preparing for your proposal, you can download the sample  Research Proposal Template  shown above.

2. Research Project Proposal Template

A research proposal is a declaration of intent to pursue a research direction, pending the approval and endorsement of proper channels. It is also a ticket for a financial grant by government agencies and private institutions. The document introduces the study, its objectives, and its significance to the scientific body and society. It also includes an overview of the research methods and techniques that the researchers plan to perform, the project timeline , as well as a breakdown of possible expenses that will be incurred during the conduct of the study. You don’t start from scratch when you get a copy of the Research Project Proposal Template  we’ve included above.

3. Brief Research Proposal Template

The document is a summary of the study. The problem statement and the methodology used for the research must be clear. The researchers should have a general idea of how their study will be conducted. This will be evident in the methods proposed. The research methodology and the schedule of activities should be feasible and realistic. This means that the materials, equipment, and facilities are available for intended use, and the results are obtainable at an expected deadline. When needed, you can resort to a Brief Research Proposal Template  with customizable content, as shown above.

4. One-Page Proposal Template

Size: A4, US

One of the essential elements in a clinical research proposal should be a well-written and timely research question that your study will focus on. Your objectives should be aligned with your thesis statement . In the same manner, your methods should closely follow the study’s objectives. The proposal is an outline of your strategy. And like any strategy, there should be thorough planning before the execution. The document will guide you while conducting research. You will be able to monitor your progress and if you have answered your problem statement and objectives. Gather all these important elements in one short research proposal. Luckily, you may use the  One-Page Proposal Template we’ve embedded above. Try it out now!

5. Nursing Research Proposal Template

A research proposal should indicate the background of the study. It should also include a review of related literature about the problem that you plan on addressing. The literature review should point to previous significant works that the researchers would use as a reference citing in their study. This applies when creating a nursing research or case study too. With the help of the  Nursing Research Proposal Template  shown above, crafting an informative and accurate research proposal while in nursing school will be easier.

6. Free Clinical Research Proposal Sample

Size: 232 KB

A good research proposal , like this sample, provides the reader with a research problem that talks about a current issue, the realistic goal of your research, and a well-explained methodology that will allow other researchers to replicate and verify your study. The specific amount and measurements, for example, should be indicated in your procedure. You must report the statistical analysis that you will perform on your data. Your statistical analysis will influence your results. Therefore, the reader must be informed on how you will treat your data. If you do not include a literature review, present a list of credible references that you will be using throughout your study.

7. Research Proposal Example

Size: 102 KB

For your reference on what makes for a compelling research proposal, you can download the sample  Research Proposal Example  embedded above. It is made by a person who qualified for the research program of the Mississippi State Department of Health. The document features a title that catches the attention of the reader. Because a person reads the title first, it can create an urge for the reader to keep reading what the writer has to say. The more content is read, the higher the chance that the proposal can sway support to your side. The research problem is relevant to the medical field and society, and the writer explains why it should be addressed. The writer expressed his or her plan on how the study will be performed. You can model your research proposal after this sample if you intend to try for a research program. Take note of the proposal guidelines for other agencies, though, as the requirements may be different.

8. Blank Research Proposal Template

Size: 114 KB

Now that you are ready to prepare a convincing research proposal, you can use the  Blank Research Proposal Template featured above. It guides you on what to include in the document. You can look for a current issue or problem in the news. Identify a field or a broad topic you wish to study, and read on scientific journals about it. As you read, you can find gaps in the literature. You can also refer to the recommendations in some research articles for help in your next research topic. You can create a flow chart along the way so you will have a guide on your project. Remember the tips you have learned in this article and incorporate them into your proposal.

Proposal Maker

Text prompt

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• Professional

Generate a proposal for a new school recycling program

Compose a proposal for a school field trip to a science museum.

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iium rESEARCH eTHICS cOMMITTEE

How to write research proposals.

Writing a research proposal is an essential step in the process of initiating and conducting a research project. A well-crafted research proposal serves as a roadmap for your research and helps convince others (such as funding agencies or academic institutions) of the importance and feasibility of your study. Here’s a general guide on how to write a research proposal:

Start with a clear and concise title that reflects the main theme of your research.

2. Introduction

Provide a brief introduction to the research problem, background information, and the context of your study. Clearly state the research question or hypothesis.

3. Literature Review

Review existing literature related to your research topic. Discuss the key theories, findings, and gaps in the current knowledge. This section helps you position your research within the broader academic context.

4. Objectives and Research Questions

Specify the objectives of your study and the specific research questions you aim to address. Ensure that these are clear, focused, and directly related to your research problem.

5. Methodology

Detail the research design, methods, and techniques you plan to use. Include information about your sample size, data collection methods, and data analysis procedures. Discuss why these methods are appropriate for your study.

6. Significance of the Study

Explain the potential impact and significance of your research. Describe how your study contributes to existing knowledge and why it is relevant to the academic or practical field.

7. Theoretical Framework (if applicable)

If your research is grounded in a particular theoretical framework, provide a brief explanation of the framework and how it informs your study.

8. Research Timeline

Outline a timeline for your research, including key milestones and deadlines. This demonstrates that you have a realistic plan for completing the project.

9. Budget (if applicable)

If your research requires funding, provide a detailed budget. Include costs for materials, equipment, travel, and any other relevant expenses.

10. Ethical Considerations

Discuss any ethical considerations associated with your research, including how you plan to address them.

11. Conclusion

Summarize the main points of your proposal and restate the importance of your research. Conclude by emphasizing why your study is worth pursuing.

12. References

Include a list of references cited in your proposal. Ensure proper citation in a consistent format (e.g., APA, MLA).

13. Appendices (if necessary)

Attach any additional materials, such as survey instruments, consent forms, or supplementary information, in the appendices.

General Tips:

• Follow the guidelines provided by the funding agency or academic institution.
• Write in a clear, concise, and formal style.
• Proofread and edit your proposal for clarity, coherence, and correctness.

Remember that a well-organized and persuasive research proposal is crucial for gaining support and approval for your research project. Adjust the structure and content based on the specific requirements of your target audience and the nature of your research.

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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 Medical Writing Center Model in an Academic Teaching Hospital

• Published: 18 May 2024

Cite this article

• Heather C. McNeill   ORCID: orcid.org/0009-0009-6422-4736 1 ,
• Jacqueline D. Hill 1 , 2 , 4 ,
• Myles Chandler 1 ,
• Eric T. Rush 2 , 3 , 5 &
• Martha Montello 1  

Editing services within academic health centers are uncommon, and few studies have reported on their impact. In this article, we describe our medical writing center’s editing service for faculty and trainees at a pediatric teaching hospital and associated outcomes of scholarly products (e.g., manuscripts and grants) over an 8-year period. Data for manuscripts and grant proposals edited by the writing center from 2015 through 2022 were collected electronically from our service request database. Outcome data on publications and grant proposals were regularly collected up to 12 months post-submission. Users were also asked if the writing center edits were helpful, improved readability, and if they planned to use the service in the future. From 2015 through 2022, the writing center received 697 requests, 88.4% to edit a document. Of the documents edited, 81.3% of manuscripts and 44.4% of grant proposals were successfully published or funded. When rating their experience, 97.8% of respondents rated the edits “helpful,” 96.7% indicated the edits “improved readability,” and 99.3% stated they planned to use the writing center in the future. Our results showed steady use of the writing center and high satisfaction with services. A writing center can be an effective tool to support psychology faculty development.

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All authors contributed to the study design and conception. Data collection and analysis were performed by MC and JH. Sections of the first draft of the manuscript were written by HM and JH, and all authors reviewed and commented on previous versions of the manuscript. All authors read and approved the final manuscript.

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McNeill, H.C., Hill, J.D., Chandler, M. et al. The Medical Writing Center Model in an Academic Teaching Hospital. J Clin Psychol Med Settings (2024). https://doi.org/10.1007/s10880-024-10020-w

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ChatGPT, the artificial intelligence (AI) chatbot designed to assist with language-based tasks, can effectively extract data for research purposes from physicians' clinical notes, UT Southwestern Medical Center researchers report in a new study.

Their findings , published in npj Digital Medicine , could significantly accelerate clinical research and lead to new innovations in computerized clinical decision-making aids.

"By transforming oceans of free-text health care data into structured knowledge, this work paves the way for leveraging artificial intelligence to derive insights, improve clinical decision-making, and ultimately enhance patient outcomes ," said study leader Yang Xie, Ph.D., Professor in the Peter O'Donnell Jr. School of Public Health and the Lyda Hill Department of Bioinformatics at UT Southwestern.

Dr. Xie is also Associate Dean of Data Sciences at UT Southwestern Medical School, Director of the Quantitative Biomedical Research Center, and a member of the Harold C. Simmons Comprehensive Cancer Center.

Much of the research in the Xie Lab focuses on developing and using data science and AI tools to improve biomedical research and health care. She and her colleagues wondered whether ChatGPT might speed the process of analyzing clinical notes—the memos physicians write to document patients' visits, diagnoses, and statuses as part of their medical record—to find relevant data for clinical research and other uses.

Clinical notes are a treasure trove of information, Dr. Xie explained; however, because they are written in free text, extracting structured data typically involves having a trained medical professional read and annotate them. This process requires a huge investment of time and often resources—and can also introduce human bias.

Existing programs that use natural language processing require extensive human annotation and model training. As a result, clinical notes are largely underused for research purposes.

To determine whether ChatGPT could convert clinical notes to structured data, Dr. Xie and her colleagues had it analyze more than 700 sets of pathology notes for lung cancer patients to find the major features of primary tumors, whether lymph nodes were involved, and the cancer stage and subtype.

Overall, Dr. Xie said, the average accuracy of ChatGPT to make these determinations was 89%, based on reviews by human readers.

Their analysis took several weeks of full-time work compared with the few days it took to fine-tune data extraction from the ChatGPT model. This accuracy was significantly better than other traditional natural language processing methods tested for this use.

To test whether this approach is applicable to other diseases, Dr. Xie and her colleagues used ChatGPT to extract information about cancer grade and margin status from 191 clinical notes on patients from Children's Health with osteosarcoma, the most common type of bone cancer in children and adolescents. Here, ChatGPT returned information with nearly 99% accuracy on grade and 100% accuracy on margin status.

Dr. Xie noted that the results were strongly influenced by what prompts ChatGPT was given to perform each task—a phenomenon called prompt engineering. Providing multiple options to choose from, giving examples of appropriate responses, and directing ChatGPT to rely on evidence to draw conclusions improved its performance.

She added that using ChatGPT or other large language models to extract structured data from clinical notes could not only speed clinical research but also help clinical trial enrollment by matching patients' information to clinical trial protocols. However, she said, ChatGPT won't replace the need for human physicians.

"Even though this technology is an extremely promising way to save time and effort, we should always use it with caution. Rigorous and continuous evaluation is very important," Dr. Xie said.

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Vitalik Buterin's Ethereum Wallet Proposal, Scribbled in 22 Minutes, Gets Positive Reviews

A fter a technical proposal to improve Ethereum wallets met with some opposition, a familiar figure swooped in last week to devise an alternative: none other than Vitalik Buterin, the blockchain's co-founder.

It reportedly took him 22 minutes.

The origin of the story dates back to last month, when Ethereum developers decided to include Ethereum improvement proposal EIP-3074 – allowing for certain functions in wallets to be controlled by smart contracts – in its next big network upgrade, known as the Pectra hard fork.

The work to make Ethereum wallets less clunky is part of a technological move called account abstraction , in which Ethereum externally-owned account (EOA) wallets, the most popular on the blockchain, are turned into smart-contract wallets.

After EIP-3074 was released, some in the community praised the proposal, while others expressed their displeasure. The main concern was that it was not compatible with an earlier proposal, called ERC-4437, which has been on mainnet since February 2023.

A couple days after EIP-3074 was released, Buterin co-wrote a new one, EIP-7702 , which serves as an alternative to what is now included in the upcoming Pectra upgrade .

Ethereum core developer Ansgar Dietrichs, who co-wrote EIP-3074 and EIP-7702 with Buterin, said in an interview with CoinDesk via chat that the newest proposal was “the result of a week or so of him being involved in the account abstraction research conversation.”

After the research was done, Dietrichs said, Buterin “indeed speedran the process of writing that EIP.”

“I challenged him to do it in 15," Dietrichs recalled. "It took him 22.”

Since the release of EIP-7702, many have praised the alternative, and it seems likely to replace the original EIP-3074.

"There is positive sentiment among all stakeholder groups" for Buterin's alternative, Christine Kim, a vice president of research at the digital-asset firm Galaxy, wrote in a May 20 research note.

Jarrod Watts, the developer relations engineer at Polygon, wrote on X that “It's one of the most impactful changes Ethereum is going to have... EVER.”

For now, EIP-3074 is still considered to go live with Pectra. That might change once the details of EIP-7022 are worked out.

“People are still understanding the exact differences to 3074,” Dietrichs told CoinDesk. “But I would say it’s pretty likely that we will replace 3074 with it.”

Galaxy's Kim suggested that the episode offered an example of how Ethereum's decentralized governance works in practice.

"It can result in constructive dialogue between different stakeholder groups in an open-source project that ultimately results in a new path forward with higher consensus among participants than before," Kim wrote.

Once Buterin got involved, it didn't take long.

Read more: Ethereum Developers Target Ease of Crypto Wallets With 'EIP-3074'