how to write research proposal in pharmacy

How to prepare a proposal for pharmacy research

A research proposal is often necessary to secure the required funding or resources. Cathy Geeson explains what to consider when putting a proposal together.

Source: Corbis Super RF / Alamy

When writing a research proposal you are aiming to produce a concise, clear summary of a proposed research project. This may form part of your academic studies, but often it is written to obtain the funding or resources needed to undertake the research. The proposal will need to be tailored to your audience, who may be academic supervisors, an organisation or an external funding body, but many of the principles of writing a research proposal remain consistent.

Putting together a proposal can take a considerable amount of time (an average of 9–12 months), so you need to be able to justify investing your time and that of your research team. You should approach writing a research proposal in the same way you would tackle any important project — do your background preparation, get the right team around you, make a plan and, finally, maintain your enthusiasm and determination to succeed.

The research topic

The most important thing to consider when choosing a topic is whether it poses a worthwhile question that needs to be answered and will result in tangible benefits within a reasonable and defined period. You should be able to demonstrate that the project will fill a gap in current literature.

Ask your peers and employers whether they believe the topic is important. Additionally, you could speak to the research team at the Royal Pharmaceutical Society (RPS) and members of the public to get their opinions.

Early considerations

Think carefully about what you want to achieve, whether funding is required and, if so, what type of funding may be suitable. Initially, you will need to consider how much money you are looking for and whether you are seeking a personal award, leading to a Masters or doctoral qualification, or funding for a larger research team. If the latter, you will need to demonstrate that you have enough experience to apply as the lead applicant.

You need to ensure that your proposal is practical and deliverable. Most awards are time-limited, typically between one and five years with most limited to three years, which means you will need to be realistic about how long you believe your research will take. Additionally, most awards are for a set amount of money, so you need to ensure that this is likely to cover all necessary resources and costs.

Different funding bodies will back different types of research so you will need to apply to the most appropriate organisation. For example, in the UK, the Medical Research Council funds basic or invention research whereas the National Institute for Health Research (NIHR) focuses on applied, evaluative and clinical research.

Ensure that the right infrastructure is in place within your organisation – this includes having appropriate management and support arrangements. Additionally, depending on the type of research, you may need to have access to sufficient patients and quality data. This may mean collecting your own data rather than trying to retrospectively assemble data that was not originally intended for research purposes.

Finally, you must be able to justify that your proposal is ethically acceptable. Although this does not mean preparing for ethics approval in detail at this stage, you should think about whether the benefits of undertaking the research outweigh the risks and burdens to potential participants.

Getting the right support

Your most important resource will be your research team. The members of your team will depend on your experience — for example, you may need an academic supervisor if the award is to support Masters or doctoral studies — and your research question and design; for example, you may require a statistician or a health economist. Decide who you require and try to obtain their support at an early stage. Be mindful of practical issues, such as the feasibility of arranging meetings. Support from your employer (and potential research site) is also crucial, particularly if you propose undertaking a secondment from your current role. At this stage you may also need to consider involvement from patients or the public or both (see ‘Patient and public involvement’).

It is also advisable to contact the research manager within your organisation and, depending on the research funder, you may also have access to design support. For example, the NIHR has a dedicated ‘research design service’ (RDS) to provide further guidance on the application process itself. The RDS also provides a number of training courses, together with ‘bid development’ advice, which can be valuable in helping hone your research proposal.

Try not to overlook other potential sources of help and advice. Researchers who have published work in the field may be willing to provide further advice on their methodology. My tip would be to seek as much advice and guidance as possible from a wide range of sources.

Once you have finalised your research methodology you can consider in depth what physical resources you will need, including access to patients, healthcare professionals and laboratory testing. The methodology will also inform the potential size and overall costs of your study. Talk to your finance department as early as you can — this can help ensure that your costs are thorough and realistic.

Writing your proposal

Research funding applications are generally highly structured and are split into sections that will vary by funder and funding stream. Each section will include clear instructions, usually including strict word limits. The funder is also likely to provide comprehensive guidance notes, plus an advice service should you need further clarification.

Remember that your proposal may be reviewed by panel members who do not work in your field, so avoid jargon and explain all abbreviations in full, ideally in each section (in case reviewers do not read your application in the order it was written). In terms of your writing style, aim for professional, clear and concise. Pay attention to detail, ask your research team to review your proposal and accept all offers to proofread your work.

Example of sections within the application form

Patient and public involvement (ppi).

Many funders are committed to the involvement of patients and the public so you may need to consider relevant activities as part of your application. These activities can involve patients and the public helping choose the research topic, assisting in the design, advising on the research project or actually helping carry out the research.

Plain English summary

You may be required to provide a brief summary of your research, written in language that members of the public should understand, so it is worth getting this reviewed as part of your PPI.

Scientific abstract

The scientific abstract is a more detailed summary that outlines the background to the research, the aims of the work, the plan of investigation and a synopsis of the potential benefits.

Background and rationale

You will then need to state your main hypothesis and research questions, and justify why the research is important and relevant to the funder. Think carefully about the benefits of your work — you will need to show the funder that your proposal is worth their investment. This section may also include your literature review, with details of gaps in current understanding of your topic, and how existing literature has informed your methodology. The funder will need evidence that you have carried out a thorough review, including any databases or citation indexes you have searched.

Research plan

In the research plan you should provide a structured protocol. It needs to be detailed enough to explain clearly how you intend to conduct the research but also succinct, because the word count is likely to be limited. You may also need to submit a ‘research timetable’ to highlight expected important milestones.

Expected outputs and dissemination

Additionally, you will need to assure the funder that the results of your research will deliver tangible benefits and that you will share these results widely.

Management and governance

You should be able to demonstrate that you will manage the award well, emphasising the results that you will deliver and how you will control the finances. This section may also include a review of ethical issues. Ensure that you are familiar with the ‘Research governance framework for health and social care’ from the Department of Health (England) and its implications for your work. Depending on the research methodology you may need to consider whether you will need informed consent from patients and other participants, and you will almost certainly have to address any confidentiality issues.

Intellectual property

Intellectual property (IP) provides the basis for protecting information, ideas and developments that your research may generate. The IP you generate will be retained by you and your organisation, but the funder will want to know that the IP will be protected (for example, with copyright or a patent) and used appropriately to ensure that the proposed research benefits can be delivered. Financial returns are an uncommon benefit of applied or clinical research but, where income generation is anticipated, you may need to enter into a commercialisation agreement with the funder to clarify how the revenue will be shared. This is an area where you may need to seek expert advice (for example, from ‘ NHS Innovation Hubs ’ ).

Making your proposal stand out

• Read the funder’s guidance notes carefully, and address each point thoroughly;
• Explain why yours is an important research question, with clear benefits;
• Be precise and succinct — could you describe clearly the main objective of your research in one or two sentences?
• Demonstrate that your proposal is well planned, feasible, cost-effective, and will yield high quality results with a positive impact;
• Justify everything fully, including your method, required resources and team members;
• Be consistent. For example, if you have said you need a PPI steering group, ensure this is included as a research cost and that meetings are built into your research timetable.

You may also be interested in

Maintaining trust in science and increasing research literacy

How our pharmacy network is developing research opportunities for the profession

Are we self-actualising in pharmacy.

• Enroll & Pay
• KU School of Pharmacy
• Doctor of Pharmacy (Pharm.D.)
• Medicinal Chemistry
• Pharmacology & Toxicology
• Pharmacy Practice
• Neuroscience

Research Proposal Guidelines

To satisfy the research requirement for the distance M.S. program in Pharmaceutical Chemistry, the aspiring student must define a research project and prepare a written proposal describing the nature and goals of the project.

It is suggested that the student in conjunction with their distance research mentor collaborate in the selection of and the definition of the proposed research. The proposal should consist of the following elements:

• Overall goal or hypotheses
• Statement of significance of the research
• Research plan consisting of several specific aims.

The following description serves to define expectations regarding proposal preparation.

Project Title

An appropriate title should be created that describes the overall research topic.

Overall Goal

Write a short statement that clearly defines the scope of the project.

Background and Significance

Become familiar with a published work that is related to your chosen research area. Provide a summary of the background in a manner that demonstrates a knowledge of the area and goes on to describe the significance of the proposed research in adding to and extending existing knowledge.

Specific Aims

The overall project should be envisioned as a series of sub-goals, which as they are individually accomplished, allows results in the achievement of the overall goal.  The specific aims should include a description of the experiments to be conducted. It should be clearly stated what is to be accomplished in each specific aim and how these results relate to the achievement of the overall research goal.

Bibliography

Appropriate literature citations should be provided in each section of the proposal, as justification for the proposed research, and to clearly indicate that the student has familiarized themselves with the research topic.

The M.S. research proposal should be limited to approximately four pages, excluding the bibliographic section.

The proposal preparation will satisfy one credit hour of the research requirement.

Thesis proposal

In Pharmacy, the MSc thesis proposal and the PhD thesis proposal are required courses (PHARM 601 and PHARM 616A/B, respectively). The objective is for students to learn how to use the literature to stimulate in-depth thinking about the basis of their thesis research project and to encourage the development of their scientific oral presentation skills, to best prepare and present their research objectives in written and oral form.

In addition to preparing a written and oral presentation of their proposed research, students must complete the following course requirements:

• Involves completing online modules as well as participation in an in-person session co-hosted by the Pharmacy Liaison Librarian and an Advisor from the Writing and Communication Center.
• Provides background on literature searching, citation and proper management of references as part of the preparation of the thesis proposal.  
• The workshop is offered once per term, as needed. 
• Students should attend in their first term, before they register in the thesis proposal course
• Workshop dates are communicated via email and/or Outlook calendar invitation.
• Attend a one-on-one appointment with the Pharmacy Liaison Librarian to discuss. research strategies and reinforce academic integrity.
• Attend two thesis proposals (or one thesis proposal and one thesis defence) by other students in Pharmacy, before their own thesis proposal examination.
• MSc students must hold the thesis proposal examination before the end of their second term.
• PhD students must hold their thesis proposal examination within their first year of the PhD program, before the end of term three.
• Any student requiring more time must request an extension, subject to the approval of the Graduate Officer.

The advisory committee appointment must be approved and the first meeting of the committee held before the proposal examination can take place.

Thesis proposal guidelines

The thesis proposal should outline the reasons for undertaking the project, concisely survey the relevant literature, present a detailed description of the methodology to be used, and outline any preliminary results.

Generally, a report of 30-40 pages is required, not including figures, legends, or references. Excess pages may be removed or disregarded.

Additional material including raw data may be included in appendices if there is a need for it to be included.

The completed thesis proposal should be double-spaced with 1-inch margins and size 12 font.  

The style of the report should follow conventions familiar to the area of research of the student.  At minimum, the written thesis proposal report should include the components indicated in the following table.

Students may wish to follow the  preparation of the thesis organization and formatting requirements, set by the Graduate Studies Office, to help prepare them for the final thesis submission.

Scheduling the thesis proposal examination

Follow the steps below when you are ready for your proposal examination:  

• Select two possible dates and times and ask your committee to save those dates until the exam is confirmed.
• Refer to "what to expect at the thesis proposal" to determine how much time you should book for your proposal (two hours is generally enough time for an examining committee with three examiners; additional time may be required for deliberation).
• If you did not sign up for the appropriate course (Pharm 601 or Pharm 616A/B) during the course enrolment period, complete and submit the Graduate Studies course drop/add form at the same time as submitting the meeting request form. 
• The grad coordinator will arrange the examination chair, prepare the proposal examination report, and set up IT support for the day of your exam (for in person and hybrid exams only).
• This is to ensure IT has the equipment/adapters necessary for the exam and not scrambling on the day of your exam.
• It will take approximately 15-30 minutes to go over everything.
• Your email request should be sent no sooner than one week prior to the test/training date.
• Submit an electronic copy of the (written) thesis proposal to each member of the examination committee and cc the grad coordinator at least 10 business days ahead of the proposal examination date.

What to expect at the thesis proposal examination

The oral examination will take approximately 2 hours and should consist of a 25-30 minute PowerPoint presentation, followed by questions from the examination committee.  Due to time limitations for the oral examination, it may not be possible to cover all aspects of the proposal in the presentation.

The question period will involve a first round of questions from the committee lasting 10-15 minutes per committee member, followed by a second round of questions in the same format but usually only 5-10 minutes each. Questions may be taken from the audience and the student's response to questions from the audience may be considered in the evaluation of the student. 

Thesis proposal examinations are not ‘public’ in the same sense that thesis defences are and are not announced throughout the Faculty of Science.  The administrative coordinator will inform pharmacy graduate students of upcoming proposal presentations so they may attend toward fulfillment of the thesis proposal course requirements.  External friends and relatives are not permitted to attend. 

Following the oral examination, the audience and students are excused so the committee can deliberate. All examiners should be present for deliberation.  After deliberation, the student is invited back into the room to hear the results of their exam. Students will receive a summary of their final grading assessment once the report has received approval. 

Assessment of the thesis proposal

Assessment of the thesis proposal is twofold:  The written proposal report and the oral presentation and discussion are each marked separately and independently by three or more committee members (the examining committee) using the thesis proposal grading sheet, following the grading scheme below. The final course grade is calculated by averaging the total scores of all examining committee members; t he assessment of whether or not the student has met the standards for the proposal and for progress in their graduate program overall, is recorded on the thesis proposal examination report . All members of the thesis proposal examination committee participate in grading and in the assessment of the student's overall progress.

Thesis proposal grading scheme

Students must complete all graduate courses with a final mark of 70% or greater, as noted in the Academic Calendar.

Thesis proposal examination report

The decision as to whether standards for the proposal and progress to date are met is made by the committee, recorded by the chair, and reported to the Faculty of Science usingthesis proposal examination report. Committee members assesses the student's position by indicating 'excellent', 'satisfactory', or 'unsatisfactory', in the following areas:

• Understanding of the material: Candidate shows adequate depth and scope of knowledge for the current stage of the project;
• Ability to handle discussion: Candidate is able to understand the pitfalls and interpretation of the project;
• Research progress: Student demonstrates a general level of progress considering the complexity of the work and practical difficulties.

Performance and standards of research concerning expectations for the degree level as well as they pertain to timely completion of the degree are indicated with a yes/no response.  Any questions, concerns, difficulties or corrective measures required by the student must be recorded in the comments sections of the report; the committee must specify an action plan outlining what the student is expected to do by a specified date. 

Pharmacy blackout dates

Pharmacy has blackout dates during which thesis proposals and PhD comprehensive exams are not be held unless special arrangements have been made and confirmed in advance by the pharmacy graduate office. Blackout dates exist to allow maximum participation in the Pharmacy program and to minimize scheduling conflicts for examination chairs and committee members. 

Blackout dates are also noted on the Pharmacy Graduate Studies Outlook calendar. 

• Thesis formatting
• Thesis information
• Academic Calendar - School of Pharmacy

Table of Contents

Developing the research idea.

• Download PDF

“The idea of finishing my project within 1 year initially seemed overwhelming. While each individual step seemed manageable, the totality of the project made me cringe and even lose sleep occasionally (honestly, quite often). Despite the valuable guidance I received from my mentors, they didn’t seem to share my level of anxiety about the project. After all, it was my residency certificate that was hanging in the balance! Overall, I’m grateful for the experience because it taught me so much and really prepared me for future projects.” —Former PGY2 Ambulatory Care Resident

LEARNING OBJECTIVES

Identify how to write a scientific research question that meets PICOTS ( P opulation, I ntervention, C omparison group, O utcomes, T imeline, and S etting) or FINER ( F easibility, I nteresting, N ovel, E thical, and R elevant) criteria.

Formulate primary and secondary study objectives.

Formulate study hypotheses and select related outcome measures.

Develop a research proposal and timeline.

INTRODUCTION

As you embark on your research journey, you are probably asking yourself, Where do I begin? What needs to go into the research question? If so, this chapter will lay out a step-wise process for building the foundation of your project:

Identifying a research question.

Searching and appraising background scientific literature.

Writing study objectives.

Specifying and defining outcomes.

Compiling these elements into a study protocol.

This chapter will equip you with the tools to accomplish these steps ( Figure 1-1 ).

CONCEIVING THE RESEARCH IDEA

Where do good research ideas come from? Creating a focused, relevant research idea may be one of the biggest challenges for a new researcher. A great place to identify research ideas is from your own clinical practice, such as when you encounter problems but cannot find solutions in the scientific literature. You may also want to evaluate the way evidence-based care has been implemented at your institution. 1 , 2 Problems may relate to a patient-specific clinical question (e.g., “What is the relationship between benzodiazepine use and emergency department utilization in the elderly?”), institutional concerns related to quality measures defined by The Joint Commission or the Centers for Medicare & Medicaid Services (e.g., “How can we increase bisphosphonate use in women who have experienced an osteoporosis-related fracture?”), resource justification (e.g., “What is the value of a clinical pharmacist as part of a diabetes-management team?”), or process improvement (e.g., “Is there a more efficient way to conduct double-checks of intravenously prepared products?”).

As a resident, your clinical experience is typically limited to rotations from pharmacy school or a previous residency; you may not have been in your practice site long enough to recognize a relevant research question. Engaging in dialogue with preceptors and mentors about possible research ideas can be the first step in building your own skills in idea development. By asking research questions, you can help to build skills in identifying relevant questions. If you have to formulate your own idea, a good place to start is by reviewing the literature about a general topic that interests you. Many studies end with recommendations for future research. Another tactic is to attend poster sessions or lectures at professional meetings where you can talk with investigators to get their ideas for needed research. 1 , 2

The Research Process

• Download Figure
• Download figure as PowerPoint slide

Regardless of where your research idea originates, the research question developed from the idea should address an unmet need or a gap in current understanding. Its answer should also contribute to improved patient care. For example, a medication adherence tool with demonstrated utility improving adherence in patients with asthma could be investigated as a strategy to increase insulin adherence in patients with Type 1 diabetes mellitus.

Once you have an idea that meets a need and interests you, the next step is to formulate it into a well-written research question. There are three general types of research questions:

Descriptive questions seek to describe a current situation or what now exists. These ­questions may be answered by qualitative and/or quantitative research methods.

Relational questions examine a relationship between different phenomena and utilize quantitative research methods.

Causal questions evaluate the cause-and-effect relationship between one or more variables and an outcome of interest; these, too, employ quantitative methods. 1 - 3

Developing a Research Question Using PICOTS Criteria

Research question, example 1.

Do patients with human immunodeficiency virus (HIV) infection have better outcomes when they take a statin?

This is a good start, but the question needs to be more focused before study design efforts can begin. The PICOTS ( P opulation, I ntervention, C omparison group, O utcomes, T imeline, and S etting) criteria are useful for ensuring that your research question contains the necessary elements, while the FINER ( F easibility, I nteresting, N ovel, E thical, and R elevant) criteria help to ensure that a study is feasible and worth doing ( Table 1-1 ). 4 - 6 The PICOTS criteria are applied first to example 1 below.

PICOTS and FINER Criteria 4 – 6

Your target patient population is patients with HIV, but you need to be more specific. Examining all patients with HIV is too broad and, obviously, impossible. For example, you may include any of the following variations:

Where is your population of interest from? A managed care organization in California? Medicaid patients in the state of Ohio? Hospitalized patients?

What are the characteristics of your population of interest? All adults? A specific age range? A specific viral load range? A specific CD4 count range? Patients with cardiovascular risk factors?

Is the population limited to those on antiretroviral therapy and any particular kind of therapy, or to newly diagnosed patients not taking antiretrovirals?

The point is to be specific . You will need precise inclusion and exclusion criteria in your protocol to define the study population.

Intervention

Next, consider the intervention. Interventions may include a new strategy, drug exposure, service exposure, or application of a tool (e.g., pharmacist delivery of medication management services, text message reminders). A prospective trial for the example question could randomize the patient population to receive either a statin or a placebo. For an observational study to address this ­question, you could study an historical exposure instead of a prospective intervention:

Taking a specific statin (e.g., atorvastatin) or statin intensity.

Taking any statin but for a certain period of time.

Comparison Group

Do not underestimate the importance of a good control group.

Is there an appropriate comparison group available?

What kind of comparison (e.g., placebo, active, historical) will be used?

The value of pharmacist interventions has not been adequately demonstrated due to failure to identify a control group or a selection of one that is biased. Ideally, this group should look as much like your intervention or exposure group as possible, but it should not have received the intervention. Historical controls can be used, if necessary, but be aware they often differ from the intervention group in significant ways. If using a parallel control group (i.e., one whose exposure and outcomes occur within the same timeframe as the intervention group), you can make them more comparable by matching them on characteristics that might affect the outcome such as exposure date, age, sex, or an indicator of disease severity.

Make sure the outcomes you choose are meaningful, measurable, and occur frequently enough to be observable in your study.

Specifically, what type of outcome(s) should be examined?

Ideally, you should examine outcomes that matter. Examples include morbidity, mortality, hospitalizations, or events such as fractures or heart attacks. In reality, these types of outcomes may occur so infrequently that very large sample sizes would be required to detect true differences between groups, which may limit feasibility. Sample size limitations usually require surrogate outcomes, such as low-density lipoprotein levels, CD4 counts, bone mineral density, and ­adherence. Keep in mind that many other types of outcomes are relevant, including economic, humanistic, quality, or educational outcomes. In addition, not all outcomes have to be purely clinical in nature. For example, identifying if a particular intervention leads to a certain outcome can be an important question to answer.

The duration of the follow-up period to evaluate outcomes is important.

Is the duration 2 weeks?

Is the duration 6 months?

Is the duration 1 year or more?

The length of the follow-up period must be specifically stated.

The setting refers to where the study will take place, such as an outpatient physician practice, an inpatient hospital setting, or a classroom setting with pharmacy students. The revised question could be as follows:

Do Ohio Medicaid outpatients, aged 18 to 75 years, diagnosed with HIV within the past 2 years and with a CD4 T-cell count >350 cells/mm 3 who initiated statin therapy within 1 year of diagnosis have improved CD4 counts 1 year after statin initiation as compared to similar patients with HIV, matched by diagnosis month, not taking a statin?

Research Question, Example 2

Does a home blood pressure (BP) monitoring program improve hypertension control?

First, apply the PICOTS criteria. Consider the questions noted below.

Are you interested in patients with a diagnosis of hypertension and uncontrolled BP versus controlled BP? How will you define “uncontrolled”?

How will home BP monitoring be conducted? Will patients be asked to monitor BP using an automated home BP cuff and take measurements 3 times per week? What else is involved with the program? Will patients enter data into a database or a patient portal linked to an electronic medical record? Who will receive the data?

Will you compare patients enrolled versus those who are not enrolled in the program in the same clinic or in a separate clinic? Would a historical comparator group be comparable (e.g., guidelines change)?

Is the outcome of interest a change in systolic and diastolic BP or achieving a specific BP goal?

Will you measure the outcome at 6 months, 12 months, or both? Are you able to bring study participants in for a specific follow-up visit and measurement, or are you relying on self-reported measures?

In what setting will these patients receive care (e.g., ambulatory clinic, community pharmacy)? The revised question could be as follows:

Does enrollment in a pharmacist-managed home BP monitoring program increase the proportion of hypertensive patients with uncontrolled BP at baseline who achieve their target BP after 6 months, compared to similar patients at an ambulatory care clinic not participating in the program?

Additional examples of research questions that have been revised using PICOTS criteria are included in Table 1-2 .

Example Research Questions Revised Using PICOTS and FINER Criteria 4 – 6

Developing a research question using finer criteria, feasibility.

Is your study feasible?

Questions to consider include the following:

Can the study population be clearly identified?

Can you identify a large enough sample size?

Do you have, or will you be able to obtain, appropriate data to examine the study question?

Do you have the technical expertise? Will you need additional help (e.g., biostatistician, content expert, someone with regulatory experience)?

What is the cost of the study? Is internal/external funding needed? If so, can you obtain it?

Can the study be conducted in the necessary time period?

As a pharmacy resident, this is the amount of time available for the actual study once you factor in any required Institutional Review Board (IRB) approval (see Chapter 3 ), data requests, and preparation of a presentation and a manuscript (see Chapters 10 and 11). Look again at your research objective(s)—did you confine yourself to one to three objectives? Having too many research objectives or collecting too much data reduces the likelihood of completing the primary focus of your project. The key to completing your project by the end of your residency is keeping it tightly focused.

If the answer to many of these feasibility questions is no , then reconsider the idea. Consult with your research team to identify how this idea could become feasible or if a different research project should be undertaken.

Interesting

Does the research question interest you?

Working on a research project can be a tedious process; if you begin the project feeling that your question is mundane or uninteresting, finishing your project will be a challenge. Your research question also needs to be interesting to a journal editor if you want to publish your work. Your residency program should provide a structure for identifying an idea that allows you flexibility in meeting this criterion. To illustrate, some residency programs may have a model in which the previous year’s resident hands over a project for the next resident to continue in the following year. Alternatively, you may complete a small project that is part of a larger project—understanding the project’s role in the big picture can allow you to recognize its significance. If a project does not seem interesting or ambitious, consider building the case for a larger one that the initial project could help to support.

Does the research question confirm or refute previous findings? Does it seek new conclusions? Does it fill a gap in the literature?

Confirm this with your literature search. Skimping on this step will have negative consequences when you try to publish. It may be acceptable to use a published idea and apply it with a more local focus. Is the question important to your department or hospital or important to improving the quality of patient care at your practice site?

Can the study be conducted in an ethical manner?

For example, a retrospective study that investigates the effect of co-pay increases on adherence would be ethical, whereas a prospective study that randomly raised co-pays on some Medicare beneficiaries would place an unethical financial burden on patients. A study examining the effect of not providing counseling to patients for new medications would be unethical and unlawful. Investigative studies inherently carry more ethical risk than observational study designs. The IRB will scrutinize potential ethical issues carefully as they are charged with protecting patients.

Is the study question relevant to clinical practice and patients?

Some questions are interesting to study, but they may not be relevant given current guideline recommendations or patient needs. For example, studying the impact of an intervention to improve patient adherence in an outpatient practice may not be as pressing when providers are prescribing evidence-based therapies at a low rate in that practice setting.

CONDUCTING A LITERATURE REVIEW

A literature review should be completed in the early stages of a research project and serves three purposes:

Increase your scientific understanding of the area of focus.

Ensure that your research question is novel or clarifies ambiguity around previous research.

Provide ideas on how to best fill in the gaps in the current understanding of your focus area. 4 , 6

Ensuring that your work builds on existing literature and does not duplicate other research is vital to future publication. A well-written literature review helps to build a compelling case for why your project needs to be done, and serves as background for your protocol and eventual manuscript once the project is completed. To fulfill these purposes, you need to build a comprehensive search strategy.

Key Tips: General Literature Search Strategy

• ✓ Use at least two databases (e.g., PubMed, GoogleScholar, EMBASE).
• ✓ Check references of the “key” studies that address your research topic.
• ✓ Use the Cited By feature in PubMed to identify additional studies published on similar topics.
• ✓ Check with content experts to ensure relevant studies are not missed.
• ✓ Search for gray literature —literature that falls outside of the mainstream domains for publication. Some examples include publications that have not been indexed in PubMed or Embase, government organizations’ annual reports, and proceedings of professional meetings that align with your topic. Gray literature can be located using an internet search or Google Scholar or by searching abstracts from relevant professional meetings.
• ✓ To be as inclusive as possible in your literature search, avoid limiting searches by date.
• ✓ Develop a process for reference management up front (see the Managing References section).
• ✓ Save the search strategy and repeat the search periodically to ensure the most recent literature on the topic has been identified, especially prior to presenting the project and/or writing the manuscript.

Organizing and Evaluating Literature Search Results

Finding a method to organize and synthesize the findings of your literature search helps you organize your ideas and find key facts that you may need to reference later. This will help others understand the scope of evidence about the topic and the different types of published studies. You also need to provide a critique about the relevance and quality of the published evidence. Consider how the study findings can be compared and contrasted and then identify strengths and weaknesses of each study. Categorize papers into different topics or headings using an Excel spreadsheet with headings for study design, methods, key findings, and critiques (see the example in Table 1-3 ). 7 A second option is to create an annotated bibliography (see the Recommended Readings section for resources on annotated bibliographies).

Sample Excel Spreadsheet with Study Description 7

Managing references.

Managing references can be a cumbersome process. Online reference managing programs to aid in this process are plentiful; use one of them to keep track of your references ( Table 1-4 ). These programs facilitate the numbering of references, especially when multiple authors provide edits, and ease the process of incorporating reviewer feedback.

Reference Management Resource

APA = American Psychological Association; DOI = digital object identifier; MLA = Modern Language Association; PDF = portable document format

DEVELOPING A STUDY PROTOCOL

The study protocol is the document that will guide the conduct of your research. This includes the study’s background, research question, objectives, methods, and statistical analysis that will be used as well as outcomes to be measured. 4 If the protocol is given to another researcher, he or she should be able to understand and replicate your study. The study protocol includes two main ­components—the introduction or background and the methods .

Writing the Background

Your literature review will guide and simplify writing the background section of your protocol. This portion of the protocol provides the background and rationale for the research project. The quantity of information needed in your background will vary based on the existing information on the topic. Usually, one to two pages in length is appropriate; however, your institution may prefer less material (e.g., one paragraph) for the IRB protocol (see Chapter 3 ). Writing a longer background will help you synthesize the current literature and provide a foundation for your manuscript once the study has been conducted. The background section should identify how your study will fill a gap in the literature and build on existing knowledge. The following information is a general overview to writing a background section. 8

Answer three questions:

What is known about your topic? Describe relevant published literature (i.e., standard of care, guidelines) and provide enough information and context for the reader to become familiar with the topic without getting too broad. For example, a project on primary non-adherence to bisphosphonates should not go into an extensive background on diagnosis and epidemiology of osteoporosis, but should quickly get to the actual problem at hand.

What is not known? Outline gaps in the literature, focusing on the gap(s) your study hopes to address.

Why is your study important? Explain the importance of the problem or critical barrier to progress in the field that your project addresses and what contribution is expected to be made to close the gaps.

End with the research question/purpose statement for your study.

Determining the Methods

The next section of the protocol focuses on how you will conduct the project or the methodological approach and study design. This section includes a description of the study site, inclusion and exclusion criteria, participant recruitment process, data collection methods, research instruments, study variables and outcomes, and data analysis approach. These topics will be addressed in the following chapters. Refer to the outline in Exhibit 1-1 for more information about specific details to include in your study protocol.

WRITING OBJECTIVES, HYPOTHESES, AND OUTCOME MEASURES

Writing objectives.

After you have written your research question and conducted a literature review, you can write research objectives. The objectives form the backbone of the protocol. 4 The objective(s) or aim(s) identify knowledge gaps that the study will fill; identify what the study will achieve; and guide the study design, analysis, and reporting of results. A study can have multiple objectives, but one should be designated as the primary objective. The primary objective is the axis around which the study is designed and is key to determining the necessary sample size. Developing tightly focused study objectives is essential to conducting a successful project. Make sure you have one clear primary objective and no more than two or three secondary objectives . As a clinician, you have been trained to consider myriad factors in caring for your patients, but as a researcher, you must avoid diverting efforts in too many directions and subsequently losing focus on your primary ­objective. 4 , 6 , 10

Refer back to the example study questions stated earlier in the chapter. Example study objectives for those research questions are listed below.

Primary objective: Compare 6-month and 1-year changes in CD4 T-cell counts between patients who are receiving a statin compared with those who are not.

Secondary objective: Compare 6-month and 1-year changes in plasma HIV ribonucleic acid counts between the study groups.

Primary objective: Compare BP control rates at 6 months in patients enrolled in a pharmacist-managed home BP program to rates in patients receiving usual care (i.e., not enrolled in a program).

Secondary objective: Compare absolute change in systolic and diastolic BP between the two study groups.

Secondary objective: Compare the number of visits required to achieve BP control between the two groups.

Formulating a Hypothesis

A study hypothesis is the prediction of the relationship between one or more factors and the problem under study. 3 , 4 , 11 A hypothesis is appropriate for an intervention or evaluative study, but it is generally not applicable for a descriptive study. Hypotheses should be identified prior to the research, and state the specific relationship between the variables you plan to collect and the study outcome variables. You should have at least one hypothesis for each study objective/aim; more than one hypothesis statement can be written, but it is not required.

Hypothesis statements have many different characteristics ( Table 1-5 ). First, hypotheses may be stated as a null or alternative hypothesis. A null hypothesis posits no difference between two or more groups under examination, whereas an alternative hypothesis indicates that you expect to observe a difference between groups. The null hypothesis is commonly used during statistical analysis (see Chapter 5 ). Second, a hypothesis statement may be nondirectional or directional. A ­ nondirectional hypothesis indicates that a relationship between variables is predicted, but the direction of the outcome—higher versus lower, better versus worse, increased versus decreased—is uncertain. A directional hypothesis indicates the anticipated direction of the relationship between ­variables. Lastly, a hypothesis may be associative or causal. Associative hypotheses make no judgment regarding causality and suggest the only thing that can be stated with certainty is a change in one variable is associated with a change in the other. In contrast, a causal hypothesis is used to infer that a change in one variable (e.g., pharmacist intervention) directly causes a change in an outcome variable. 3 , 4 , 11

The following hypothesis statements are based on the example research questions in the previous section.

Examples of Hypothesis Statements 11

HIV = human immunodeficiency virus

Hypothesis: Patients with HIV who receive a statin will have improved CD4 T-cell counts compared to patients with HIV who are not taking a statin.

Hypothesis: Patients randomized to a pharmacist-managed home BP program will achieve greater BP control compared to patients who are randomized to receive usual care (i.e., no program).

Specifying Study Outcomes (Endpoints)

A study outcome is the specific phenomenon you are going to measure to represent your objective. 3 , 4 In other words, the primary endpoint should be representative of the primary objective. For a quantitative study, it should be measurable and represented as a number or proportion. Also, the numerator and denominator for how the outcome will be calculated should be determined. A study outcome, for example, could be the proportion of patients in each group who express that they are adherent to their antiretroviral regimen.

The following are examples of study outcome measures using the example research questions.

The proportion of patients with HIV with a CD4 count >350 cells/mm 3 . (The numerator is the number of patients with a CD4 count >350 cells/mm 3 , and the denominator is the total number of patients with HIV and a CD4 count measured in the past N number of days.)

The mean change in systolic BP from baseline to 6 months follow-up.

COLLABORATING WITH YOUR RESEARCH TEAM

Research is a collaborative, interdisciplinary process; therefore, you will likely require others’ cooperation to complete your project successfully. As a pharmacy resident, you may have been assigned an individual mentor or team of collaborators to work with on your project. In future research endeavors, the need for a team and members to be included on the team will vary. When working with a team, it is helpful to define the roles and responsibilities of each team member at the ­beginning of the project. For some projects, the level of involvement for each person will vary with some people taking responsibility for certain tasks or contributing expertise at specific phases of the project (e.g., data analyst extracting data from medical records during data collection phase). In other projects, it may be expected that all team members share the responsibilities throughout the course of the study. Working in a team setting can be rewarding; however, team dynamics can be challenging to manage. It is necessary to maintain open communication and flexibility to prevent potential misunderstandings and ensure that everyone is engaged, as needed. The initial team meeting should include a discussion of the following items:

Establishment of ground rules for respectful team dynamics

Identification of who needs to be on the team and their respective roles on the project

Communication preferences

Frequency of team meetings

Authorship and authorship order

Goal journal submissions

Key Tips: Successful Collaborations

• ✓ Schedule meetings proactively at regular time intervals, especially while developing the protocol. You can always cancel if meetings are not needed.
• ✓ Create an agenda for each meeting.
• ✓ Take minutes to record decisions made and work to share; send minutes to participants after the meeting, including action items, who is responsible, and by what deadline.
• ✓ Create a central place to store study-related documents (e.g., literature, protocol) so that all team members have access to all documents (e.g., Google Drive, Dropbox, Box).

DEVELOPING A STUDY TIMELINE

To keep your research project on track and check feasibility, it is important to create a timeline. Most residency research projects occur over 1 year, so it is helpful to work backward from the residency completion date to ensure that you allocate time appropriately to complete your study and draft the manuscript or final study report. Allot extra time for IRB approval and data collection in case of unanticipated setbacks. Ask about the IRB meeting dates before starting the research process and target the date you plan to submit your project for review. It is important to know those dates so you can allot time for the approval process or revise your proposal, if needed. Revise the timeline, as required, if setbacks occur, and ensure that all research team members agree about project expectations. Additionally, allow sufficient time (e.g., 1−2 weeks) for mentors to provide feedback about your study implementation plan and documents. Better yet, ask how much notice they need to review documents so that you can accommodate their schedules. Incorporating a plan for publication into the timeline is beneficial, and expectations for publication should be discussed with your research team. 5 A sample timeline is provided in Table 1-6 .

Sample Study Timeline 10

* It is not unusual for revisions to extend beyond the completion of your residency. Consider building this extra work into your timeline.

IRB = Institutional Review Board

A Gantt chart is another tool to aid project planning ( Table 1-7 ). A Gantt chart includes all research activities in the order they are expected to occur and plots how much time will be allocated for each activity. Consider including additional columns for who is responsible for completing each milestone or additional rows with greater detail for activities that support accomplishing each milestone. 12

Implementing a research project begins with writing a well-crafted research question. The PICOTS and FINER criteria are useful tools to guide the development and refinement of your question. Once the question is finalized, formulating a search strategy to uncover relevant literature will guide further refinement of your research question and writing of the study protocol. Regular meetings with your study team to draft and finalize the study protocol, especially the background and methods, will ensure that your project has a strong foundation.

Key Takeaways

• ■ Identify the knowledge gap your study will address by critically evaluating the literature and consulting with colleagues.
• ■ Write the research question using PICOTS and/or FINER criteria.
• ■ Search for existing information on the topic and refine the research question.
• ■ Identify a strategy for referencing the relevant literature.
• ■ Develop a study protocol and outcome measurement strategy.
• ■ Create and implement a study timeline.

Lipowski EE . Developing great research questions . Am J Health-Syst Pharm . 2008 ; 65 : 1667 – 1670 .

• Search Google Scholar
• Export Citation

Haynes RB . Forming research questions . J Clin Epidemiol. 2006 ; 59 : 881 – 886 .

Smith KM . Building upon existing evidence to shape future research endeavors . Am J Health-Syst Pharm . 2008 ; 65 : 1767 – 1774 .

Aparasu RR . Research Methods for Pharmaceutical Practice and Policy . London, UK : Pharmaceutical Press ; 2011 .

Aparasu RR , Bentley JP . Principles of Research Design and Drug Literature Evaluation . Burlington, MA : Jones & Bartlett Learning ; 2015 .

Hulley S , Cummings S , Browner W , et al. et al. Designing Clinical Research . 3rd ed. Philadelphia, PA : Lippincott, Williams & Wilkins ; 2007 .

Smolen JS , Kay J , Doyle MK , et al. et al. Golimumab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor alpha inhibitors (GO-AFTER study): a multicentre, randomised, double-blind, placebo-controlled, phase III trial . Lancet. 2009 Jul 18 ; 374 ( 9685 ): 210 – 221 .

Welch HG . Preparing manuscripts for submission to medical journals: the paper trail . Eff Clin Pract . 1999 ; 2 : 131 – 137 .

NEJM Resident 360 Website . Sample research protocol template . https://resident360.nejm.org/content_items/1839 . Accessed July 15 , 2019 .

Weber RJ , Cobaugh DJ . Developing and executing an effective research plan . Am J Health-Syst Pharm . 2008 ; 65 ( 21 ): 2058 – 2065 .

Farrugia P , Petrisor BA , Farrokhyar F , et al. et al. Research questions, hypotheses, and objectives . Can J Surg. 2010 Aug ; 53 ( 4 ): 278 – 281 .

Wilson JM . Gantt charts: a centenary appreciation . Eur J Oper Res. 2003 ; 149 : 430 – 437 .

RECOMMENDED READINGS

The references listed below outline how to develop research ideas and a plan as well as write research questions.

Research Planning

Al-Ryami A . How to prepare a research proposal . Oman Med J . 2008 ; 23 ( 2 ): 66 66−69 69 .

Weber RJ , Cobaugh DJ . Developing and executing an effective research plan . Am J Health-Syst Pharm . 2008 ; 65 ( 21 ): 2058 2058−2065 2065 .

Planas LG . Intervention design, implementation, and evaluation . Am J Health-Syst Pharm . 2008 ; 65 : 1854 1854−1863 1863 .

Smith FJ . Conducting Your Pharmacy Practice Research: A Step-by-Step Guide . 2nd ed. London, UK : Pharmaceutical Press ; 2010 .

Research Questions

Lipowski EE . Developing great research questions . Am J Health-Syst Pharm . 2008 ; 65 : 1667 1667−1670 1670 .

Smith KM . Building upon existing evidence to shape future research endeavors . Am J Health-Syst Pharm . 2008 ; 65 : 1767 1767−1774 1774 .

Raich AL , Skelly AC . Asking the right question: specifying your study question . Evid Based Spine Care J . 2013 ; 4 ( 2 ): 68 68−71 71 .

PubMed (Medline) . https://www.ncbi.nlm.nih.gov/pubmed/ . Accessed March 31 , 2020 .

Google Scholar . https://scholar.google.com . Accessed March 31 , 2020 .

EMBASE . https://www.elsevier.com/solutions/embase-biomedical-research . Accessed March 31 , 2020 .

International Pharmaceutical Abstracts . https://www.ovid.com/product-details.109.html . Accessed March 31 , 2020 .

Cochrane Collaboration . http://www.cochrane.org/ . Accessed March 31 , 2020 .

ClinicalTrials.gov . https://clinicaltrials.gov/ . Accessed March 31 , 2020 .

Web Resources

ASHP Foundation . Essentials of a Practice-Based Research for Pharmacists . https://www.ashpfoundation.org/research . Accessed March 31 , 2020 .

Gantt Charts . https://www.teamgantt.com . Accessed March 31 , 2020 .

Annotated Bibliography Guide . http://guides.library.cornell.edu/annotatedbibliography . Accessed March 31 , 2020 .

Annotated Bibliography Example . http://www.ucdenver.edu/academics/colleges/pharmacy/AcademicPrograms/clinical-pharmacy-toolkit/Documents/annotatedbibliography_clinical-pharmacy-integration-into-pcmh.pdf . Accessed March 31 , 2020 .

Study Protocol Outline 9

I. Title Page

A. Protocol title, principal investigator, co-investigators, date

B. Affiliations for all investigators

II. Abstract (optional)

A. Brief one-page summary of proposed research; this section may be shorter depending on institution requirements

III. Background and Rationale

A. Significance of research question

B. Last sentence should be the study purpose/main research question

IV. Study Objectives (Aims)/Hypothesis

A. Primary objective

B. Secondary objective(s)

A. Study design (e.g., prospective, retrospective, randomized, cohort); include statement that IRB approval will be obtained

B. Study setting and population

i. Brief description of study setting

ii. Inclusion/exclusion criteria

C. Study procedures

i. Describe subject identification and/or recruitment

ii. Describe informed consent process (written or verbal) (if applicable)

iii. Describe subject enrollment process (if applicable)

iv. Describe procedures for intervention, methods for blinding, randomizing, detailed description of what will occur once subject is deemed eligible for study (if applicable)

v. Describe criteria for assignment to study versus control group (exposure)

vi. Describe data collection, including all required data elements, sources, date ranges, and storage

D. Outcome measures

i. Primary outcome

ii. Secondary/tertiary outcomes

VI. Analytical Plan

VII. Study Timeline

VIII. References

IX. Appendixes (separate documents)

A. Data collection tools, consent forms, patient information letters, surveys, etc.

© 2024 American Society of Health-System Pharmacists. All Rights Reserved.

Powered by:  PubFactory

• [66.249.64.20|195.190.12.77]
• 195.190.12.77

Character limit 500 /500

How to write a successful grant application: guidance provided by the European Society of Clinical Pharmacy

• Open access
• Published: 06 March 2023
• Volume 45 , pages 781–786, ( 2023 )

Cite this article

You have full access to this open access article

• Anita E. Weidmann   ORCID: orcid.org/0000-0003-3670-2357 1 ,
• Cathal A. Cadogan 2 ,
• Daniela Fialová 3 , 4 ,
• Ankie Hazen 5 ,
• Martin Henman 6 ,
• Monika Lutters 7 ,
• Betul Okuyan 8 ,
• Vibhu Paudyal 9 &
• Francesca Wirth 10  

4088 Accesses

3 Citations

6 Altmetric

Explore all metrics

Considering a rejection rate of 80–90%, the preparation of a research grant is often considered a daunting task since it is resource intensive and there is no guarantee of success, even for seasoned researchers. This commentary provides a summary of the key points a researcher needs to consider when writing a research grant proposal, outlining: (1) how to conceptualise the research idea; (2) how to find the right funding call; (3) the importance of planning; (4) how to write; (5) what to write, and (6) key questions for reflection during preparation. It attempts to explain the difficulties associated with finding calls in clinical pharmacy and advanced pharmacy practice, and how to overcome them. The commentary aims to assist all pharmacy practice and health services research colleagues new to the grant application process, as well as experienced researchers striving to improve their grant review scores. The guidance in this paper is part of ESCP’s commitment to stimulate “ innovative and high-quality research in all areas of clinical pharmacy ”.

Similar content being viewed by others

A survey of the European Society of Clinical Pharmacy members’ research involvement, and associated enablers and barriers

Writing a Grant Proposal for a Single Centre Study: Step-by-Step Approach

Development of a standard form for assessing research grant applications from the perspective of patients

Avoid common mistakes on your manuscript.

Writing research grants is a central part of any good quality research. Once a detailed research proposal has been submitted, it is subjected to an expert peer review process. Such reviews are designed to reach a funding decision, with feedback provided to improve the study for this and any future submissions. Depending on the length of the proposal, complexity of the research and experience of the research team, a proposal can take between six to twelve months to write [ 1 ]. Ample time must be given to the writing of hypothesis/research aim, budgeting, discussion with colleagues and several rounds of feedback [ 2 ]. The draft research proposal should always be completed well before the deadline to allow for last minute delays. An application which is not fully developed should not be submitted since it will most likely be rejected [ 3 ].

Despite the large effort that goes into each grant application, success rates are low. Application success rates for Horizon 2020 were < 15% [ 4 ] and < 20% for the National Institute of Health (NIH) [ 5 , 6 , 7 , 8 ]. With these statistics in mind, it is evident that often repeated submissions are required before securing funding. Due to a paucity of specific clinical pharmacy grant awarding bodies, writing a grant application for a clinical pharmacy or pharmacy practice research project often involves multidisciplinary collaborations with other healthcare professions and focus on a specific patient population or condition. There is no guarantee of success when trying to secure funding for research. Even the most seasoned researchers will have applications rejected. The key is to never give up. This commentary provides useful pointers for the planning and execution of grant writing.

Conceptualising your research idea

Before writing a research grant proposal/application, consider what the research should achieve in the short, medium, and long term, and how the research goals will serve patients, science and society [ 9 , 10 ]. Practical implications of research, policy impact or positive impact on society and active patient/public involvement are highly valued by many research agencies as research should not be conducted “only for research”, serving the researchers’ interests. EU health policy and action strategies (CORDIS database) and other national strategies, such as national mental health strategy for grants within mental disorders, should be considered, as well as dissemination strategies, project deliverables, outcomes and lay public invitations to participate. The Science Community COMPASS has developed a useful “Message Box Tool” that can help in the identification of benefits and solutions, as well as the all-important “So What?” of the research [ 11 ]. Clearly determine what the lead researcher’s personal and professional strengths, expertise and past experiences are, and carefully select the research team to close these gaps [ 12 , 13 , 14 ].

How to find the right funding call

When trying to identify the right type of grant according to the research ambitions, one should be mindful that several types of grants exist, including small project grants (for equipment, imaging costs), personal fellowships (for salary costs, sometimes including project costs), project grants (for a combination of salary and project costs), programme grants (for comprehensive project costs and salary for several staff members), start-up grants and travel grants [ 15 ]. Types of grants include EU grants (e.g. Horizon, Norway Grant), commercial grants (e.g. healthcare agencies and insurance companies), New Health Program grants ideal for new, reimbursed clinical pharmacy service projects and national grants (e.g. FWF (Austria), ARRS (Slovenia), NKFIH (Hungary), NCN (Poland), FWO (Belgium), HRZZ (Croatia), GAČR (Czech Republic), SNSF (Switzerland), SSF (Sweden). It is worth remembering that early career researchers, normally within ten years of finishing a PhD, have a particular sub-category within most grants.

Many national agencies only have one “Pharmacy” category. This results in clinical pharmacy and advanced clinical pharmacy practice projects competing with pharmaceutical chemistry, pharmaceutical biology and pharmacy technology submissions, thereby reducing the success rate as these research areas can often be very advanced in most EU countries compared to clinical and advanced pharmacy practice. A second possible submission category is “Public Health”. Several essential factors can impact the grant selection, such as research field, budget capacity, leading researcher’s experience and bilateral grants. Examples of successful clinical pharmacy funded research studies can be found in the published literature [ 16 , 17 , 18 , 19 , 20 ].

Plan, plan, plan

One key element of successful grant writing is the ability to plan and organise time. In order to develop a realistic work plan and achieve milestones, it is imperative to note deadlines and to be well-informed about the details of what is required. The development of a table or Gantt Chart that notes milestones, outcomes and deliverables is useful [ 21 ].

All funders are quite specific about what they will and will not fund. Research your potential funders well in advance. It is vital to pay attention to the aims, ambitions and guidelines of the grant awarding bodies and focus your proposal accordingly. Submitting an application which does not adhere to the guidelines may lead to very early rejection. It is helpful to prepare the grant application in such a way that the reviewers can easily find the information they are looking for [ 15 , 22 ]. This includes checking the reviewers’ reports and adding “bolded” sentences into the application to allow immediate emphasis. Reviewers’ reports are often available on the agencies’ websites. It is extremely useful to read previously submitted and funded or rejected proposals to further help in the identification of what is required in each application. Most funding agencies publish a funded project list, and the ‘Centre for Open Science (COS) Database of Funded Research’ enables tracking of funding histories from leading agencies around the world [ 23 ]. Another useful recommendation is to talk to colleagues who have been successful when applying to that particular funder. Funding agency grant officers can provide advice on the suitability of the proposal and the application process.

It is important to pay particular attention to deadlines for the grant proposal and ensure that sufficient time is allocated for completion of all parts of the application, particularly those that are not fully within one’s own control, for example, gathering any required signatures/approvals. Funders will generally not review an application submitted beyond the deadline.

Lastly, it is important to obtain insight into the decision process of grants. Research applications are sent to several reviewers, who are either volunteers or receive a small compensation to judge the application on previously determined criteria. While the judging criteria may vary from funder to funder, the key considerations are:

Is there a clear statement of the research aim(s)/research question(s)/research objective(s)?

Is the proposed research “state-of-the-art” in its field and has all relevant literature been reviewed?

Is the method likely to yield valid, reliable, trustworthy data to answer question 1.?

If the answer to the second question is ’yes’, then what is the impact of financing this study on patient care, professional practice, society etc.?

Is there sufficient confidence that the research team will deliver this study on time with expected quality outputs and on budget?

Does the study provide value for money?

How to write

The key to good grant proposal writing is to be concise yet engaging. The use of colour and modern web-based tools such as #hashtags, webpage links, and links to YouTube presentations are becoming increasingly popular to improve the interest of a submission and facilitate a swift decision-making process. Ensure use of the exact section headings provided in the guidance, and use the keywords provided in the funding call documentation to reflect alignment with the funding bodies’ key interests. Attention to detail cannot be overstated; the quality and accuracy of the research proposal reflect the quality and accuracy of the research [ 24 ]. Try to adopt a clear, succinct, and simple writing style, making the grant easy to read. Having a clear focus can help to boost a grant to the top of a reviewer’s pile [ 25 , 26 ]. A clearly stated scientific question, hypothesis, and rationale are imperative. The reviewer should not have to work to understand the project [ 27 ]. Allow for plenty of time to incorporate feedback from trusted individuals with the appropriate expertise and consider having reviews for readability by non-experts.

What to write

Abstract, lay summary and background/rationale.

Take sufficient time to draft the scientific abstract and summary for the lay public. These should clearly state the long-term goal of the research, the aim and specific testable objectives, as well as the potential impact of the work. The research aim is a broad statement of research intent that sets out what the project hopes to achieve at the end. Research objectives are specific statements that define measurable outcomes of the project [ 28 , 29 ].

The lay summary is important for non-subject experts to quickly grasp the purpose and aims of the research. This is important in light of the increased emphasis on patient and public involvement in the design of the research. The abstract is often given little attention by the applicants, yet is essential. If reviewers have many applications to read, they may form a quick judgement when reading the abstract. The background should develop the argument for the study. It should flow and highlight the relevant literature and policy or society needs statements which support the argument, but at the same time must be balanced. It should focus on the need for the study at the local, national and international level, highlighting the knowledge gap the study addresses and what the proposed research adds. Ensure this section is well-referenced. The innovation section addresses the ‘‘So what?’’ question and should clearly explain how this research is important to develop an understanding in this field of practice and its potential impact. Will it change practice, or will it change the understanding of the disease process or its treatment? Will it generate new avenues for future scientific study? [ 30 ].

Hypothesis/aims and objectives

For the hypothesis, state the core idea of the grant in one or two sentences. It should be concise, and lead to testable specific aims. This section is fundamental; if it is unclear or poorly written, the reviewers may stop reading and reject the application. Do not attempt to make the aims overly complex. Well-written aims should be simply stated. Criteria such as PICO (population, intervention, comparison, outcomes) [ 31 ], and FINER (feasible, interesting, novel, ethical, relevant) [ 32 ], provide useful frameworks to help in writing aim(s), research question(s), objective(s) and hypotheses. Pay attention to the distinction between aim(s), research question(s), objective(s) and hypotheses. While it is tempting to want to claim that enormously complex problems can be solved in a single project, do not overreach. It is important to be realistic [ 25 ].

Experimental design, methods and expertise

The methodology is one of the most important parts of getting a grant proposal accepted. The reviewing board should be convinced that the relevant methodology is well within the research teams’ expertise. Any evidence of potential success, such as preliminary results or pilot studies strengthen the application significantly [ 33 ]. The methodology must relate directly to the aim. Structuring this section into specific activities/ set of activities that address each research question or objective should be considered. This clarifies how each question/ objective will be addressed. Each work-package should clearly define the title of the research question/objective to be addressed, the activities to be carried out including milestones and deliverables, and the overall duration of the proposed work-package. Deliverables should be presented in table format for ease of review. Each subsequent work-package should start once the previous one has been completed to provide a clear picture of timelines, milestones and deliverables which reflect stakeholder involvement and overall organisation of the proposed project. Using relevant EQUATOR Network reporting guidelines enhances the quality of detail included in the design [ 34 ]. Key elements of this methodology are detailed in Table  1 .

Proposed budget

The budget should be designed based on the needs of the project and the funding agency’s policies and instructions. Each aspect of the budget must be sufficiently justified to ensure accountability to the grant awarding body [ 35 ]. Costing and justification of the time of those involved, any equipment, consumables, travel, payment for participants, dissemination costs and other relevant costs are required. The funders will be looking for value for money and not necessarily a low-cost study. Ensure that the total budget is within the allocated funding frame.

Provide a breakdown of the key work packages and tasks to be completed, as well as an indication of the anticipated duration. Include a Gantt chart (A table detailing the most general project content milestones and activities) to demonstrate that all aspects of the proposal have been well thought through [ 21 ].

Critical appraisal, limitations, and impact of the proposed research

It is important to detail any strengths and limitations of the proposed project. Omitting these will present the reviewing board with sufficient grounds to reject the proposal [ 36 ]. Provide a clear statement about the short and long-term impact of the research [ 37 , 38 ]. The reviewers will pay particular attention to the differences the study can make and how potential impact aligns with the funding bodies goals as well as national policies. This statement is essential to make an informed decision whether or not to support the application. Useful diagrams summarise the different levels of impact [ 39 ].

Table  2 provides a summary of the key elements of project grants and key questions to ask oneself.

Although the grant writing process is time-consuming and complex, support is widely available at each stage. It is important to involve colleagues and collaborators to improve the proposal as much as possible and invest time in the detailed planning and execution. Even if the grant is not awarded, do not be disheartened. Use the feedback for improvement and exercise resilience and persistence in pursuing your research ambition.

The guidance in this paper is part of ESCP’s commitment to stimulate “innovative and high-quality research in all areas of clinical pharmacy”. In a previous ESCP survey, it was found that few opportunities for collaboration (especially for grant applications) was one of the key barriers for members towards conducting research [ 40 ]. ESCP promotes networking, which is essential for multi-centre grant applications, both among ESCP members and with other organisations as it recognises the need for “multi-centre research in all areas of clinical pharmacy both within countries and between countries or differing healthcare delivery systems”. ESCP is planning to relaunch its own research grant which was paused during the pandemic, and it is also planning to provide ESCP members with information about the research grants offered by other organizations. ESCP is exploring partnering with other organisations to develop research proposals in areas of common interest and, in the near future, it will ask its members about their research priorities. Taken together, these initiatives will inform ESCP’s research strategy and help it to formulate policies to address the challenges its members face.

Devine EB. The art of obtaining grants. Am J Health-Syst Pharm. 2009;66(15):580–7.

Article   PubMed   Google Scholar  

Arthurs OJ. Think it through first: questions to consider in writing a success grant application. Paediatr Radiol. 2014;44:1507–11.

Article   Google Scholar  

Elsevier Connect. 5 pitfalls to writing a wining grant application for your research. 2019. https://www.elsevier.com/connect/5-pitfalls-to-writing-a-winning-grant-application-for-your-research . Accessed 05 Dec 2022.

Best practice guidelines. WASP (write a Scientific Paper): writing a research grant – 1, applying for funding. Early Hum Dev. 2018;127:106–8.

National Institute for Health (NIH). Success Rates: R01-Equivalent and Research Project Grants. 2022. https://report.nih.gov/nihdatabook/category/10 . Accessed 05 Dec 2022.

Deutsche Forschungsgemeinschaft (DFG). Processing Times and Success rates., 2021. https://www.dfg.de/en/dfg_profile/facts_figures/statistics/processing_times_success_rates/index.html . Accessed 05 Dec 2022.

Mervis J. Odds improve for winning NSF grants, but drop in applications troubles some observers. Science. 2022. https://doi.org/10.1126/science.adc9471 .

Myklebust JP. Should the ERC be worried about its low success rate? University World News. 2021 https://www.universityworldnews.com/post.php?story=20210521093708482 Accessed 05 Dec 2022.

Koppelmann GH, Holloway JW. Successful grant writing. Paediatr Respir Rev. 2012;13:63–6.

Kanji S. Turning your research idea into a proposal worth funding. Canadian J Hosp Pharm. 2015;68(6):458.

Google Scholar  

COMPASS. The Message Box. 2022. https://www.compassscicomm.org/leadership-development/the-message-box/ . Accessed 05 Dec 2022.

Ebadi A, Schiffauerova A. How to receive more funding for your research? Get connected to the right people. PloS One. 2015;10(7):e0133061.

Article   PubMed   PubMed Central   Google Scholar  

Laurent GJ. Getting grant applications funded: lessons from the past and advice for the future. Thorax. 2004;59(12):1010–1.

Article   CAS   PubMed   PubMed Central   Google Scholar  

Research funding. Vitae, realising the potential of researchers. Available at https://www.vitae.ac.uk/researcher-careers/pursuing-an-academic-career/research-funding Accessed 05 Dec 2022.

Wellcome Trust. 2022. https://wellcome.org/grant-funding . Accessed 05 Dec 2022.

McIntosh J, Alonso A, MacLure K, et al. Case study of polypharmacy management in nine European countries: implications for change management and implementation. PLOS One. 2018;13(4):e0195232.

Molino CGRC, Chocano-Bedoya PO, Sadlon A, et al. Prevalence of polypharmacy in community-dwelling older adults from seven centres in five european countries: a cross-sectional study of DO-HEALTH. BMJ Open. 2022;12:e051881.

Bhagavathula AS, Assen Seid M, Adane A, et al. Prevalence and determinants of Multimorbidity, Polypharmacy and potentially inappropriate medication use in older outpatients: Findindgs from EuroAgeism H2020 ESR7 Project in Ethiopia. Pharmaceuticals. 2021;14(9):844.

Watson MC, Ferguson J, Barton GR, et al. A cohort study of influences, health outcomes and costs of patients’ health-seeking behaviour for minor ailments from primary and emergency care settings. BMJ Open. 2015;5:e006261.

Patton DE, Pearce CJ, Cartwright M, et al. A non-randomised pilot study of the solutions for Medication adherence problems (S-MAP) intervention in community pharmacies to support older adults adhere to multiple medications. Pilot Feasibility Stud. 2021;7:18.

Gantt.com. What is a Gantt chart. 2022. https://www.gantt.com . Accessed 05 Dec 2022.

Gholipour A, Lee EY, Warfield SK. The anatomy and art of writing a successful grant application: a pratical step-by-step approach. Pediatr Radiol. 2014;44:1512–7.

Centre for Open Science. 2022. https://www.cos.io . Accessed 05 Dec 2022.

Liu JC, Pynnonen MA, St John M, et al. Grant-writing pearls and pitfalls: Maximizing Funding Opportunities. Otolaryngol Head Neck Surg. 2016;154(2):226–32.

Sohn E. Secrets to writing a winning grant. Nature. 2020;577:133–5.

Article   CAS   PubMed   Google Scholar  

Powell K. The best-kept secrets to winning grants. Nat News. 2017;545:399.

Article   CAS   Google Scholar  

McGee R. Keys to writing successful NIH research and career development grant applications. https://www.northwestern.edu/climb/resources/written-communication/Effective_NIH_Research_Career_Development_Proposals_Overview.pdf . Accessed 05 Dec 2022.

Anon. Developing Research Aims and Objectives. In: David R Thomas, Ian Hodges. Designing and Planning Your Research Project: Core Skills for Social and Health Researchers. Sage Publications. 2010. P. 38–47.

Farrugia P, Petrisor BA, Farrokhyar F, et al. Research questions, hypotheses and objectives. Can J Surg. 2010;53(4):278.

PubMed   PubMed Central   Google Scholar  

University of York. Impact in research grant applications. 2022. https://www.york.ac.uk/staff/research/research-impact/impact-in-grants/ . Accessed 05 Dec 2022.

Schardt C, Adams MB, Owens T, et al. Utilization of the PICO framework to improve searching PubMed for clinical questions. BMC Med Inform Decis Making. 2007;7:16.

Hulley SB, Cummings SR, Browner WS, et al. Designing Clinical Research. 3rd ed. Lippincott Williams & Wilkins; 2007.

Best practice guidelines. WASP (write a Scientific Paper): writing a Research Grant – 2, Drafting the proposal. Early Hum Dev. 2018;127:109–11.

EQUATOR Network. Enhancing the QUAlity and Transparency Of health Research. 2022. https://www.equator-network.org/ . Accessed 05 Dec 2022.

Patil GP. How to plan and write a budget for research grant proposal? J Ayurveda Integr Med. 2019;10(20):139–42.

UW-Madison Writing Center. Planning and Writing a Grant Proposal: The Basics. 2017. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8642360/ . Accessed 05 Dec 2022.

UK Research Impact. Research Excellence Framework. 2021. Available at https://re.ukri.org/research/ref-impact/ . Accessed 05 Dec 2022.

Hughes A, Kitson M, Bullock A, et al. The dual funding structure for research in the UK: research council and funding council 244 allocation methods and the pathways to impact of UK academics. Cambridge: Department of Innovation and Skills, UK Innovation Research Centre; 2013.

Research Councils UK. Pathways to impact. Available at https://www.publicengagement.ac.uk/do-engagement/funding/pathways-impact#:~text=A%20clearly%20thought%20through%20and,our%20economic%20and%20social%20wellbeing . Accessed 05 Dec 2022.

Stewart D, Paudyal V, Cadogan C, et al. A survey of the European society of clinical pharmacy members’ research involvement, and associated enablers and barriers. Int J Clin Pharm. 2020;42(4):1073–87.

Download references

Acknowledgements

Research works of Assoc. Prof. Fialová were also supported by the institutional program Cooperation of the Faculty of Pharmacy, Charles University.

Open access funding provided by University of Innsbruck and Medical University of Innsbruck. This work was conducted without external funding.

Author information

Authors and affiliations.

Department of Clinical Pharmacy, Innsbruck University, Innsbruck, Austria

Anita E. Weidmann

School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, Dublin, Ireland

Cathal A. Cadogan

Department of Social and Clinical Pharmacy, Faculty of Pharmacy in Hradec Králové, Charles University, Hradec Králové, Czech Republic

Daniela Fialová

Department of Geriatrics and Gerontology, 1st Faculty of Medicine, Charles University, Prague, Czech Republic

Julius Centre for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands

Ankie Hazen

Trinity College Dublin, Dublin, Ireland

Martin Henman

Kantonsspital Aarau, Aarau, Switzerland

Monika Lutters

Department of Clinical Pharmacy, Faculty of Pharmacy, Marmara University, Istanbul, Turkey

Betul Okuyan

University of Birmingham, Birmingham, United Kingdom

Vibhu Paudyal

Department of Pharmacy, University of Malta, Msida, Malta

Francesca Wirth

You can also search for this author in PubMed   Google Scholar

Corresponding author

Correspondence to Anita E. Weidmann .

Ethics declarations

Conflicts of interest.

The authors have not disclosed any competing interests.

Additional information

Publisher’s note.

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ .

Reprints and permissions

About this article

Weidmann, A.E., Cadogan, C.A., Fialová, D. et al. How to write a successful grant application: guidance provided by the European Society of Clinical Pharmacy. Int J Clin Pharm 45 , 781–786 (2023). https://doi.org/10.1007/s11096-023-01543-7

Download citation

Received : 25 September 2022

Accepted : 12 January 2023

Published : 06 March 2023

Issue Date : June 2023

DOI : https://doi.org/10.1007/s11096-023-01543-7

Share this article

Anyone you share the following link with will be able to read this content:

Sorry, a shareable link is not currently available for this article.

Provided by the Springer Nature SharedIt content-sharing initiative

• Clinical pharmacy
• Peer review
• Find a journal
• Publish with us
• Track your research

Pharmacy research project guidance: Doing your literature review

• Project Management
• Ethical Approval
• Doing a systematic literature search
• Evaluating your sources
• Doing your literature review
• Citing references
• Using EndNote
• File and Data Management
• Your Lab/Log Book
• Reflective Writing
• Supervisory Expectations
• Frequently Asked Questions

Introduction

All projects will include a literature review:

• In a lab-based project the review may just be part of the introduction helping to outline the state of the knowledge and gap you are trying to address.
• For literature-based projects this will be the bulk of your discussion, although the way your report is structured will depend on the type of review you are doing. If you are doing a systematic review you will need to follow a specific protocol for writing it up. See ' Doing a systematic literature search ' for guidance and links.

Getting started

• Video tutorial on doing a literature review

A literature review sets up your project and positions it in relation to the background research. It also provides evidence you can refer back to later to help interpret your own results. When getting started on your literature review, it helps to know what role this plays in your overall project.

A literature review:

• Provides the background / context to your topic
• Demonstrates familiarity with previous research
• Positions your study in relation to the research
• Provides evidence that may help explain your findings later
• Highlights any gaps in the research
• Identifies your research question/s

In your literature review you should include:

• Background to the topic (e.g. general considerations, mechanisms of formation, analytical techniques, etc…)
• Why it is important (e.g. food with improve flavour, less carcinogens, more taste, less processed foods, new probiotics ......... & etc.)
• What research has been performed and what has been found out
• The specific area you are interested in (e.g. cheese, snacks, fruits, ….)
• Current ideas and hypotheses in this area
• The key research questions which remain

It can seem difficult to know where to start with your literature review, but to a certain extent it doesn’t matter where you start…as long as you do!

If you like understanding the bigger picture and seeing the whole of an idea before getting into the detail – try starting with a general text and then using the bibliography of this to find more specific journal articles.

If you like to start small with one idea or study, find a relevant journal article or single study and then build up by trying to find related studies and also contrasting studies.

Further help

For more on this view the video tutorial on the other tab in this box, or take a look at these study guides:

• Starting a literature review
• Undertaking a literature review

Read the script for the video (PDF)

Note-taking

• Tips on note-taking
• Video tutorial on critical note taking

A key to a good literature review, is having a good system for recording and keeping track of what you are reading. Good notes means you will have done a lot of the thinking, synthesising, and interpreting of the literature before you come to write it up and it will hopefully make the writing process that bit smoother. Systematic note-taking will also ensure you have all the details you need to write your references and won’t accidentally plagiarise.

Have a format for recording your notes that suits you – whether this is in a table, bullet points, spider diagrams, using a programme like Evernote, or in a traditional notebook! 

Tables can be a useful way of recording notes for a literature review as it enables you to compare and contrast studies side-by-side in the table. It also forces you to write a concise summary or it won’t fit into the table!  

e.g.  A suggested outline for a note-making table

Have a system for distinguishing quotations and your own words – you don’t want to accidentally include something only to discover it was someone else’s words and you may have plagiarised by mistake. Always make sure your quotation marks are clear in your notes (it is easy to miss them in a hurry) and it really helps to record the page number of any direct quotation so you can go back to check easily.

Avoid the temptation to copy out text – copying out large chunks of text is slow and also means you tend not to process and understand what you copy. Summarising and writing short phrases instead means you are likely to have a better understanding and will remember it and be able to use your notes more easily later. 

Summarise – writing a short summary or overview of what you have just read helps you to clarify their argument and position. It also means you have a handy short reminder when you come back to it later – you don’t want to be re-reading notes that are as long as the original text in the first place!

Always record the full bibliographical details – it only takes a few moments to write down everything you need for your reference. You may think it is fine to leave it as you will be able to find these details later…but you probably won’t and you will waste time searching for them when your deadline is fast approaching.

A top tip if you find it hard to put things in your own words – try reading a longer section of the text before taking notes. It is very difficult to paraphrase something line-by-line as you go along, because everything seems important and it is too easy to just lift the phrases the author has used. Reading a longer section will give you a better overview and fuller understanding, meaning you can choose what is important and relevant to your own project. 

For more on this watch the video tutorial on the other tab in this box, or take a look at these study guides:

• Managing academic reading
• Effective note-taking study guide This guide produced by the Study Advice Team gives tips on note-taking and outlines some different approaches.

If you are unable to view this video on YouTube it is also available on YuJa - view the Critical note taking video on YuJa (University username and password required)

Referencing and avoiding plagiarism

• Managing references
• Video tutorial on avoiding unintentional plagiarism

It is a good idea to keep your references up to date as you write so that you know exactly where each idea comes from (and it will save a tedious job at the end ).

Make sure you reference every idea that comes from another source, which includes things like images, diagrams, and statistics, not just word-for-word quotations.

Use the referencing style detailed in the 'Referencing' page in this guide and stick to it consistently! Don’t switch between styles or formats. It may seem petty, but meticulously formatted referencing shows you have taken care in your work and have a professional academic approach (and it will get you marks!). You could consider using a reference management tool, such as EndNote Online, for storing your references and inserting them into your report (see the 'Referencing' page ) - this will be essential if you are doing a literature-based project or a systematic review.

A top tip is to have a proof-read through for referencing only – print out your literature review as it is easier to spot mistakes on paper than on screen.

Referencing checklist

• Is every idea from another source referenced?
• Does every word-for-word quotation have quote marks and is referenced?
• Are all paraphrases in your own words (not just changing a few words) and referenced?
• Does every in-text reference match a full reference in the bibliography?
• Are all names and titles in the references spelled correctly?
• Have you followed the department’s preferred referencing style consistently?

For more on this watch the video tutorial on the other tab in this box.

For detailed help on citing references see the Referencing page in this guide:

• Referencing guidance for the Pharmacy research project

If you are unable to view this video on YouTube it is also available on YuJa - view the Avoiding Unintentional Plagiarism video on YuJa (University username and password required)

Structuring your review

A literature review compares and contrasts the research that has been done on a topic. It isn’t a chronological account of how the research has developed in the field nor is it a summary of each source in turn like a ‘book review’. Instead a literature review explores the key themes or concepts in the literature and compares what different research has found about each theme.

Use sub-headings to structure your literature review as this helps you group the different studies to compare and contrast them and avoids a straight chronological narrative.

To help find your sub-headings:

• Brainstorm all the different concepts or themes in the research that relate to your topic or title
• Identify the ones that are important to your research question – think of what the reader needs to know about to understand the different aspects of your project
• Place the themes in an order that would make sense to your reader – usually going from broad themes to themes more directly related to your project (see funnel diagram in Getting started)
• Turn these into sub-headings
• Use these sub-headings as an outline plan for your literature review – what will come under each sub-heading

Below is an example structure of a literature review that starts broad and starts to narrow by linking the concepts that are specific to this project:

For more on this see the following study guide:

Writing the literature review

When writing a literature review, you want to be comparing and contrasting the studies to build up a picture of what the research says about your topic.

This means you should be using comparative and evaluative language more than descriptive language:

For more examples of the kinds of comparative and evaluative language used in literature reviews see:

• Academic Phrasebank Use this site for examples of linking phrases and ways to refer to sources.

Be selective

Also you want to be selective in how you refer to the literature . In a literature review, you don’t have to refer to each study in the same depth. Think of the points you want to make and then include just enough detail about the study to provide evidence for this. For example, you don’t have to analyse the strengths and weaknesses of the methodology for each study in depth, you only need to do this if you are making a point which relates to the methodology or a point about the findings which depends on the methods being robust and valid (e.g. the authors claim there are wide-spread applications of their trials, but they have used a very small sample size, which suggests they can’t make such a bold assertion). 

For example - the summary below maps out the state of current research and the positions taken by the key researchers. A significant amount of reading and in-depth understanding of the field has gone in to being able to summarise the research in these few sentences.

Sometimes you need to go into greater depth and refer to some sources in more detail in order to interrogate the methods and stand points expressed by these researchers. Even in this more analytical piece of writing, only the relevant points of the study and the theory are mentioned briefly - but you need a confident and thorough understanding to refer to them so concisely.

For example:

See the following study guide for more on this:

• Developing your literature review

Returning to your literature review - link to the discussion

Once you have written your literature review, its job doesn’t end there. The literature review sets up the ideas and concepts that you can draw upon later to help interpret your own findings.

Do your own findings confirm or contradict the previous research? And why might this be?

If your literature review funnels down from broad to narrow, you can think of your discussion like the other half of the hour-glass, broadening out to the wider applications of your project at the end:

So although you may draft your literature review as one of your first steps, you will probably come back to it towards the end of your project to redraft it to help fit in with your discussion. You may need to emphasise some studies that didn’t initially seem that important, but which are now more useful because of what you have found in your own experiments.

This is an example of the thinking that might go on behind interpreting a result and linking it to the previous literature:

• << Previous: Evaluating your sources
• Next: Citing references >>
• Last Updated: Apr 23, 2024 2:21 PM
• URL: https://libguides.reading.ac.uk/pharmacy-research-project-guide

• Privacy Policy

Buy Me a Coffee

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

You may also like

How To Write A Proposal – Step By Step Guide...

Grant Proposal – Example, Template and Guide

How To Write A Business Proposal – Step-by-Step...

Business Proposal – Templates, Examples and Guide

Proposal – Types, Examples, and Writing Guide

How to choose an Appropriate Method for Research?

Research Support

The mission of the Office of the Associate Dean for Research and Graduate Studies is to facilitate faculty and student researchers to be able to solve the complex problems and challenges facing professionals in the pharmaceutical sciences.

To accomplish this mission, we provide an administrative infrastructure to support the college’s research endeavors and to promote a collaborative and interdisciplinary research and training environment.  This support is designed to ensure the scholarly success of our faculty and to provide for exemplary training of pre- and postdoctoral students in the pharmaceutical sciences.

Submitting a proposal?  Fill out this proposal information form.

Research Support Services

Proposal and funding assistance.

• Proposal checklists and resources
• Assistance with planning and submitting proposals
• Recurring funding opportunity lists
• Search engines for funding

Office Resource Library

The resources listed below are hard copy resources available in our office:

• Directory of Research Grants - Lists over 4900 opportunities from 2500 sponsors by alphabetical order, subject, program type, and location
• The Grant Application Writer's Workbook - How to write an effective proposal for NIH, NSF, and other agencies
• Writing Grant Proposals that Win - Step-by-step guide on how to write grant proposals
• Making the Right Moves: A Practical Guide to Scientific Management for Postdocs and New Faculty - Tips for researchers on how to become better leaders in scientific management

Digital Resources

• Curated searchable database
• Funding search engines
• Pivot search tips
• Budget templates
• Checklists for funding opportunities
• Links to research compliance and policy guidelines
• Predoc and postdoc fellowship support
• Bi-weekly funding newsletter

Christina Fannon, CRA

Tonia Guida, Ph.D.

LaKesha Henry, M.A., CRA

Barbara King

Katie Traughber

• South Carolina Honors College
• Location Location
• Contact Contact
• Colleges and Schools
• About the Honors College

Senior psychology major reveals how South Carolina Honors College transformed her life

After distinguishing herself as one of the rare transfer students accepted into the highly competitive South Carolina Honors College as a sophomore, Ruth Moniz still had only a vague idea where she ultimately might fit in the wide spectrum of career opportunities for psychology majors. She was hungry for meaningful professional insight, and one Honors psychology course — Research, Practice, and Policy in School Behavioral Health — changed everything.

“Before taking this class, I knew I was interested in psychology, and I knew that I liked working with children, but, other than that, I had absolutely no idea what my future academic or professional path might look like,” Moniz recalls. “I was trying to get as much exposure as possible to different things. I was toying with the idea of counseling but didn’t really feel a strong connection to it. … I also had the opportunity to volunteer with a local middle school and trained in motivational interviewing. It was absolutely amazing and so rewarding to see the impacts of positive behavioral interventions and supports in action in a local environment.”

Finally discovering that school-based psychology would be her niche was not without its challenges. Moniz was initially intimidated by the academic rigor of Honors College courses, especially reading and understanding sophisticated academic articles. However, during the first week of Honors classes, she was stunned to experience a level of enthusiastic participation and engagement that was far different from high school. Soon, Moniz found herself looking forward to the Honors assignments and in-depth discussions.

“I had spoken to other friends who were in Honors and had read many wonderful things online about the enhanced experiences available to Honors students,” she says. “I knew that it would be a once-in-a-lifetime opportunity to take my college experience to the next level. … I had no idea just how impactful it would be.”

I would not be the student or person I am today without my Honors experience.

The psychology course was the catalyst that opened the door for Moniz to pursue her undergraduate research at USC, which ultimately led to her choice of senior thesis topic: “The use of effective health communication strategies to reduce inequitable and exclusionary discipline in schools.” It examines disciplinary practices in K-12 schools that remove students from the school environment as well as reviews the theory of planned behavior (TPB), which is how an individual’s belief systems influence their decisions to behave in a certain way.

Today, Moniz is a part-time research assistant on nationally renowned psychology instructor Mark Weist’s School Behavioral Health Team. As a senior, she was even invited to present her research findings at the 2023 Southeastern School Behavioral Health Conference where Moniz networked with top professionals in the field. She will become a full-time research assistant after graduation in May. Beyond that, she is keeping her options open.

Having previously served as a Peer Leader for University 101 programs, Moniz hopes to stay involved in the first-year seminars while preparing to apply for graduate school. She is proud that USC ranks No. 1 nationally for first-year experience and leads the state with 20 nationally ranked health science graduate programs.

“I would not be the student or person I am today without my Honors experience,” Moniz says. “I have gained so much knowledge as an Honors student, but I think, more importantly, I have gained so much more confidence in myself as a student and my ability to chase my dreams and aspirations. Honors will always have a special place in my heart.”

Challenge the conventional. Create the exceptional. No Limits.

An official website of the United States government

The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

• Publications
• Account settings

Preview improvements coming to the PMC website in October 2024. Learn More or Try it out now .

• Advanced Search
• Journal List
• Am J Pharm Educ
• v.72(4); 2008 Aug 15

Conducting a Successful Residency Research Project

The residency research project can be a challenging endeavor for pharmacy residents since they typically have limited experience in this area. Furthermore, as the number of accredited residency programs has increased, so has the demand for preceptors with research experience. This review is intended to assist the resident and preceptor by providing steps and guidance with conducting a successful residency research project. Items such as idea generation, proposing the right type of project, departmental review, and project management skills are discussed and guidance with writing the research protocol is provided. Items that must be addressed in every research protocol are described and a generalized protocol template is presented. In addition, the institutional review board review process is described and tips and pointers for obtaining approval are included. Finally, useful tools and resources are provided that can be used up front or throughout each phase of the research project.

The purpose of the residency research project is to provide the resident with the skills necessary to conduct and manage a major project over the course of 1 year. Additionally, it allows residents to prepare and present a major presentation at the regional level and improve their communication skills. Many college curriculums do not require pharmacy students to complete a major project prior to graduation; thus, the research project may be the resident's first experience with such a task and one of the more challenging aspects of completing a pharmacy residency program.

In 2006, over 1000 students successfully matched for an American Society of Health-System Pharmacists (ASHP) accredited residency, 1 a substantial increase from the 800 students matched in 2004 and 600 in 2001. The increasing number of pharmacy graduates seeking residency training has led to an increase in the number of residency programs. As of 2006, 853 ASHP-accredited programs existed, offering 1,900 positions, with 1,482 representing postgraduate year 1 (PGY-1) residency positions. This has translated into an increasing need for preceptors. While this need may be well matched with the number of qualified preceptors with regard to clinical activities, the volume of preceptors experienced in research may be limited, especially as outgoing residents transition into preceptor positions themselves. Additionally, preceptors with vast clinical experience may not have extensive research experience, as this may not be part of the job description for many pharmacists. One survey reported that only 46% of critical care practitioners were involved in research. 2

There are many varieties of major projects that exist for residents ranging from research to “non-research” ideas. For example, a non-research idea could be the development and implementation of a new service or a project related to quality improvement. These projects could be practical for a 1-year experience. Most residency projects, however, stem from a research idea or evaluation of “best-practice” at one's institution. This review is intended to assist residents and preceptors with conducting a successful residency project with an emphasis on research (as opposed to non-research projects). Procedural steps are offered along with clinical pearls and advice based on the experience of this author. Finally, useful resources are provided that can assist the pharmacist prior to and throughout the study to complete a successful research project.

IDEA GENERATION

Idea generation is the first step in conducting a research project and often a major barrier for new practitioners (Table ​ (Table1). 1 ). Potential research projects could be generated from questions that arise in everyday practice or in clinical rounds. Clinicians should consider areas where existing literature or recommendations are unavailable. If literature is available, several questions must be raised to determine whether an additional study is warranted. For example, were there inconsistencies among the results of various clinical trials? Can the methodology of these studies be improved? Was a study conducted in the population in question, and if not, would it be appropriate to extrapolate the findings from that study? Clinicians could also consult with medical/surgical attending physicians or other hospital staff members for potential research ideas. This could lead to a good research idea (and project) as well as the development of new professional relationships and the potential for future collaborations. Research ideas can also be generated from information obtained within cycles of the plan-do-study-act (PDSA) model. When developing research questions, clinicians should ultimately consider: (1) Is the study feasible? (2) Is the topic interesting (to the investigator)? (3) Is the idea new and/or novel? (4) Is the study ethical? (5) Will the results be relevant? 3 Finally, all research ideas should be consistent with the vision of the institution and yield information that is useful to the department, school, and/or college.

Steps for Conducting a Pharmacy Residency Research Project

PROPOSING THE RIGHT PROJECT

A crucial aspect of the residency research project is proposing the right type of project and it is ultimately the responsibility of the preceptor to make this determination. Most unsuccessful projects are those not suitable for a 1-year residency. While prospective, randomized, controlled trials are the best methods for answering a research question (and have the highest score in evidence-based ranking systems), they typically take several years to complete and are beyond the scope of a 1-year residency. In addition, residents may find it difficult to enroll patients given the time-sensitive nature of obtaining informed consent when they are on rotations that may not be flexible or have scheduling conflicts (eg, missing patient rounds to enroll a study patient). Therefore, priority should be given to projects where the resident can be involved with all aspects of the research study. This includes protocol development, institutional review board (IRB) submission, data collection, database development, data analysis, presentation of study results, and manuscript preparation (if required). Projects that are “handed down” from one year's resident to the next should be discouraged because they disallow exposure to all parts of a research project. If this is not possible, a special effort should be made to provide the resident with the “missing” experience by working on another project.

Given the barriers encountered in conducting a prospective trial, most residency projects should be retrospective or non-interventional (ie, observational) in nature. While this may rank lower than a randomized, controlled trial in the hierarchy of evidence-based medicine, it will yield the best learning experience for the resident in a 1-year timeframe. Even when conducting retrospective research, there are several factors that must be considered once the research question has been determined that can contribute substantially to the success of the project. The first factor is how patients will be identified. Will patient information come from a registry? ICD-9 codes? a centralized pharmacy database? Each method has its limitations, which must be carefully considered to avoid selection bias when choosing the study population. The second factor to consider is whether the required data are readily available. Are they available from a computerized database (eg, an electronic medical record) or must they be obtained from a paper-based patient record (ie, medical chart). It is important to consider not only what data are available but whether it is searchable and retrievable. A common pitfall is to assume one can obtain data that is actually not accessible. The third factor to consider is whether or not the necessary data points are clearly documented. Clinicians should keep in mind that many outcome measures may be difficult to determine in retrospect if an adequate documentation system was not in place up front. For example, early goal-directed therapy (EGDT) is a strategy for treating patients with severe sepsis/septic shock using definitive endpoints for resuscitation, hemodynamics, and oxygenation. These endpoints are to be achieved within 6 hours from the onset of severe sepsis/septic shock. 4 Early goal-directed therapy has demonstrated improvements in survival; thus, many institutions are working to implement this intervention in their emergency departments and intensive care units. If one were to study compliance with EGDT it would be necessary to assess whether specific goals were reached within 6 hours of the onset of severe sepsis/septic shock. If the onset of severe sepsis/septic shock was not clearly recorded at the time of presentation, it would be difficult to assess these endpoints.

Finally, careful consideration should be given to the sample size required to yield meaningful results and whether that sample size can be met at the given institution. For example, it would be difficult to evaluate the relationship between duration of antimicrobial prophylaxis and clinical outcomes in patients with penetrating abdominal trauma if patients with gunshot wounds were rarely admitted at one's institution. A sample size analysis should be performed to decrease the probability of type II error occurring or inappropriately accepting the null hypothesis. If a sample size is too large it may be impractical for a 1-year research project. The actual number that may be considered impractical will vary based on the type, volume, and availability of data collected. Several computer programs exist for calculating sample size. If these are not available, alternative methods (using direct mathematical calculations) do exist. 5

With any major project, it is important to plan in advance and the research project is no exception. Residents and preceptors should anticipate possible barriers such as the inability to access data, obtain patient lists, or accurately determine clinical outcomes. Additionally, a basic understanding of statistics is required so the data can be accurately interpreted upon collection. Residents and preceptors are encouraged to consult with statisticians if they are unsure how to analyze the data. If a statistician is not available at the resident's institution, several published resources are available. 6 - 11

Although funding opportunities specifically for pharmacy residents exist, the grant-writing process can be somewhat overwhelming for a PGY-1 resident. In addition, the entire process (from grant writing to acceptance of the grant) can be extremely time consuming and not fit with the goal of completing the project within 1 year. Potential barriers include delays in writing the grant, obtaining approval from the IRB, obtaining letters of support, review by the institution's grants administration department, and review by the funding agency. Residents and preceptors must consider alternative options if the grant is not funded and the project can not be started. While grant writing can be a useful experience for a resident, it should be done as an additional exercise independent of the residency research project.

DEPARTMENTAL REVIEW

Many residency programs have a residency advisory committee (RAC) that meets regularly throughout the year to discuss the residents' progress and the status of their program. The size and structure of the RAC will be specific to the program but generally consists of the residency program director, residency preceptors, and management. Preceptors (or residents) should forward their potential ideas/projects to the RAC, which is encouraged to provide input regarding the appropriateness of each proposed project. In this setting, an open forum should be provided for multiple preceptors/investigators to discuss the objectives of their project, the relevance to their department or institution, study design, potential barriers, and likelihood the project can be completed. This approach is intended to highlight issues that might not be foreseen originally by the individual generating the idea, correct suboptimal methodology, and potentially improve the efficiency of the research study. It also provides a forum for mentorship of new preceptors. Conflicts among RAC members should ultimately be resolved by the residency program director.

PROJECT SELECTION

Once an approved list of projects has been determined by the RAC, they should be presented to the residents. This list should include at a minimum the title of the project, the study goals, and the names of the preceptor(s). Before a project is selected, each resident is encouraged to conduct a literature review and determine whether the subject is an area of interest. Furthermore, residents should meet with their preceptor to discuss the project in detail and determine the goals and expectations of the preceptor. Preceptors should disclose future plans for publication along with the necessary requirements for authorship. 12 Residents should be informed that data collection alone does not satisfy these criteria, and in order to be considered an author, their commitment to the project is required even after they have graduated from the residency program.

ESTABLISHING A TIMELINE

Once an agreement has been reached between the resident and preceptor, the next step should be to develop a timeline. This timeline should include deadlines for the following components: literature review, protocol development, development of the data collection tool, IRB submission, completion of data collection, database development and data entry, and data analysis. Timelines should also include regularly scheduled meetings with the resident and all preceptors, which can help keep the project on track. This may be particularly useful for multisite programs where the resident may have clinical experiences at another institution. Ample time should be incorporated into these timelines to allow for the necessary revisions (which may actually be required multiple times) throughout the process as well as for presentation development. Time should also be incorporated for any unexpected barriers that may not have been predicted at the start of the process. As with most major projects, barriers almost certainly will be encountered and will be different for each research project (eg, delays in obtaining IRB approval, patient lists, or medical charts).

Preceptors should be in constant contact with the resident during the data collection phase to ensure adequate progress is being made. Otherwise, residents may be faced with trying to collect data on a large percentage of their estimated sample size with a short time remaining before their regional residency conference. The degree of procrastination tends to be greater with research projects than with other residency projects. This may be due to the fact that the final deadline (ie, presentation at the regional residency conference) is approximately 9 months from the start of the project with other residency responsibilities taking priority in the meantime (eg, medication use evaluations, daily topic discussions with preceptors, presentations to medical staff).

WRITING THE PROTOCOL

The protocol is the document that describes the steps that will be taken to answer the research question. A clear and concise protocol is pertinent to the success of any research project. In addition, a clearly written protocol can help facilitate manuscript preparation since many of the components (ie, introduction and methods) can be transcribed. All aspects of the study design and all data collection techniques should be included in the protocol. While there are no set criteria for writing a protocol, the common headings/subheadings are described below (Table ​ (Table2 2 ).

Components of a Research Protocol

Title Page.

The title page should contain the full title of the study along with the names, full titles and affiliations of all investigators involved. In addition, contact information (ie, mailing address, e-mail address, telephone number, and fax number) for the corresponding or principle investigator should be included. Other information might include the name of the study sponsor (if applicable).

Introduction.

The introduction should describe the specific reasons for conducting the study. A brief overview of past related studies should be provided, along with their individual limitations or conflicts with the collective literature. It is important to specify why this study may be different and the impact the results might have in clinical practice. In general, introductions should be concise but comprehensive enough to justify what led to the specific research question. The introduction should conclude with a research question that is clearly stated and easy to comprehend. The introduction will either enthrall or deter the interest of a reader or reviewer.

Objectives/Purpose.

The objectives of the study should relate to the research question that was proposed previously. As such, the variables that will be measured should be clearly identified. For example, rather than stating, “the objective of this study is to compare dexmedetomidine versus propofol in surgical patients,” one should state, “the objective of this study is to compare the incidence of delirium in patients who received dexmedetomidine versus propofol following surgery.” Furthermore, the distinction should be clearly made between the primary and secondary objectives (if applicable).

The Methods section is the most important part of the research protocol and should describe the study design, study population (which includes how patients will be identified, inclusion criteria, exclusion criteria) and study procedure. The study population and procedure must be well thought out and defined to avoid confusion or deviations once the study is underway. The study procedure should include a descriptive narrative pertaining to each step of the study process. Outcome measurements along with definitions should be provided.

Statistics.

The statistical tests that will be utilized should be noted along with a sample size analysis. Sufficient detail should be provided with the presumption that the reader would be able to verify the results themselves, given the original data set. The computer software that will be used should also be mentioned.

Data Handling and Record Keeping.

This section should describe how the data will be maintained (eg, a regulatory binder in the locked office of the PI) and if/when the de-identification tool will be destroyed. A statement regarding confidentiality could be included as well.

Miscellaneous.

Some IRBs require additional items such as a budget, data collection tool, timeline, etc. Clinicians should consult their individual IRB for specific instructions in these areas.

References.

Direct references should be provided to the original studies whenever possible. References should be numbered in the order in which they appear in the text. Since journals may vary on the format required for references, a complete listing of all authors of each publication should be provided in the protocol (as opposed to listing the first 3 authors followed by “et al”). The reference format can then be easily conformed to any journal's style.

DEVELOPING THE DATA COLLECTION TOOL

The data collection tool should be a user-friendly instrument that allows the resident to efficiently capture the necessary data. Data collection tools can be either electronic or paper based. Advantages of electronic-based instruments are that, in some instances, they can eliminate the need for transcription into an electronic database (and possibly decrease transcription errors). Disadvantages include that they require computer access, which may not be readily available. The volume of data collected should err on the side of too much rather than too little. It is easier to collect more data up front (with the realization it might not be used) than to re-collect data at a later date, especially given some of the barriers to data retrieval (eg, waiting for medical charts to be pulled, slow functioning computer databases). Nonetheless, emphasis should be placed on collecting the right data through careful planning. Residents should keep in mind that any revisions to the data collection tool after IRB submission may require resubmission and approval by the IRB before the form can be implemented. This could result in delays to project completion. Review by multiple preceptors/investigators upfront is therefore warranted.

SUBMITTING TO THE IRB

All research projects should be approved by the institutions IRB. Most IRBs have different levels of review (eg, full, expedited, or exempt) based on the type of project being proposed (Table ​ (Table3 3 ). 13 , 14 As most pharmacy residency projects will be either observational or retrospective, they may qualify for an expedited (or non-full board) review. Clinicians should consult with their IRB to determine the appropriate steps to obtain approval.

Examples 13 , 14 of Human Subject Investigations Requiring Full Review, Expedited Review, or Exempt from Review by Institutional Review Boards a

Some examples adapted from Parvizi J, Tarity TD, Conner K, Smith JB. Institutional review board approval: why it matters. J Bone Joint Surg Am . 2007;89:418-26 13

Most IRBs will require all investigators to complete some form of training, which can usually be obtained through a web-based program. One example is the Collaborative Institutional Training Initiative Program. 15 This course provides facts and information regarding common concepts and principles relative to human subject protection.

Upon submitting their protocols to the IRB, residents should assure their submissions are complete and meet all of the IRB requirements. The materials needed may vary based on whether or not the study requires full board or expedited approval. The Health Insurance Portability and Accountability Act (HIPAA) requires authorization for the release of protected health information and is usually included as part of the informed consent. Some studies (ie, retrospective studies) may qualify for waiver of authorization and this request must also be submitted to the IRB. If the IRB requires the data collection form to be submitted, careful inspection should occur to assure all information is de-identified.

It is this author's opinion that preceptors, and not residents, should serve as the principle investigator (PI). The PI is ultimately responsible for every aspect of the research study. They are also the individual listed for all correspondence from the IRB (which will typically continue beyond the time the resident may be present). Since many residents will be conducting a research project for the first time, they may not have the skills or knowledge base to assume the many responsibilities of the PI. The PI can transfer authority but not responsibility for the research study; thus, this role should be served by the preceptor. However, residents should not use this as a “safety net” and leave an unfinished project for the preceptor to complete once they have graduated.

DATA COLLECTION

The data collection phase can be a time-consuming process for a pharmacy resident, especially if the project entails retrospective chart review. It is helpful if the preceptor and the resident evaluate the first 1 or 2 patients' charts together so the resident can learn where to find certain information and develop strategies for being more efficient. This can also serve as a “pilot” for the data collection tool. It is pertinent to ensure there is no ambiguity in definitions or procedure. In fact, preceptors and residents should meet periodically to ensure the data are being collected properly. Deadlines should be set not only for 100% completion of the data collection, but for 25%, 50%, and 75% completion as well. It may be useful to conduct a preliminary analysis after approximately 10% of the total sample size has been collected to ensure the data collected will yield meaningful information and can be accurately analyzed. If necessary, alterations can be made (after the initial pilot or the preliminary analysis) to collect additional information sooner, rather than re-reviewing medical records for new data after all patients have been evaluated. If there is any variation to the protocol or data collection form, a revised form/proposal must be submitted to the IRB for approval.

DATA ANALYSIS

Statistical analysis should be done with both the preceptor and resident (and biostatistician if needed). It may be useful to have other investigators present as well. It is important that the data are validated before any statistical testing is performed. Residents and preceptors should search for incorrect data entries (eg, an extra 0 on a data entry), values that simply do not make sense (eg, ICU length of stay that exceeds hospital length of stay) or values that may have been miscoded (eg, mechanical ventilation coded as “no” but a length of mechanical ventilation of “5 days”).

It is this phase of the research study when residents will gain experience with using statistical tests and software. Preceptors (or statisticians) are encouraged to explain which tests are being used to analyze each piece of data and why this may be the most appropriate test.

DATA INTERPRETATION

Once statistical analysis has been completed, the results should be shared with all investigators. Residents should prepare a results summary page listing the values for each parameter evaluated along with a p value and the statistical test that was used. Preceptors should review these data for accuracy, trends, and limitations. In many cases, additional data may be required.

SHARING THE DATA

The final results of the research study should be distributed to the necessary individuals within the department and clinical relevance should be discussed. Action plans (based on the conclusions of the study) should be developed that are consistent with the PDSA model. 16 Once the presentation has been created, practice sessions—first between the resident and co-investigators, and then between the resident and RAC–should be scheduled. This can provide an opportunity for useful critique on the quality/structure of the presentation from clinicians who have a “fresh look” at the project. Final recommendations can then be shared with other clinicians along with the appropriate institutional governing bodies or committees (ie, Pharmacy and Therapeutics Committee, Quality Committee, etc). It is hoped that presenting the study multiple times within the institution prior to the regional residency conference will increase the resident's comfort level with the data and help promote a polished presentation. Multiple presentations will also provide the resident with the opportunity to modify the presentation for different audiences or disciplines (eg, physicians, nurses, administrators, etc).

The residency research project may be the resident's first attempt at conducting research. The key to success is proper planning by both the resident and preceptor, along with the use of an organized approach. This review has provided a framework for the resident and preceptor, highlighting the major steps throughout the process, with the goal of accomplishing a successful residency research project.

Research Funding Weeks 2024 May 21 - 31

Research funding weeks.

Join us for the Research Funding Weeks, from May 21 to May 31. Especially tailored for the UT community, this event offers researchers the opportunity to connect with support services and explore funding prospects for their research ideas. Special attention will be given to tangible how-to's and tools as first steppingstones for exploring funding further.

Dates : May 21 - May 31

Objective : Provide insights into Dutch and European funding landscapes, and practical tips and tricks on how to develop your funding efforts.

Save the dates for engaging webinar sessions, networking, and the chance to connect with experts. Look out for the official program announcement with details on speakers, panel discussions, and workshops tailored to meet the needs of our research community.

Curious about what sessions will cover? Here's a sneak peek into a few key topics:

WHERE TO LOOK, WHEN LOOKING FOR FUNDING

Wanting to write a proposal starts with knowing what to look for and where to find it. Whether it be European or Dutch research funding, you must orient yourself well first. Join several webinars for insights into the research funding landscape and discover how to find the right funding instrument(s) for you.

LEARN FROM OTHER'S MISTAKES, BEFORE MAKING THEM YOURSELF...

Whether an application is granted or not is ultimately in the hands of a small group of people: the assessment committee members! Both in Dutch and European funding instrument they hold the power for the final assessment and score your proposal. Join a webinar on insider’s view on assessment procedures and learn how to optimize your winning chances.  

WRITE BETTER AND QUICKER PROPOSALS WITH AI?

Uncover the transformative capabilities of Generative AI tools like ChatGPT and MidJourney in shaping research proposals. How can they help you with innovative ideation, content creation, optimization strategies and even revolutionize your proposal writing methods? Join a webinar for an insightful exploration of Generative AI's potential for your proposal development. 

More recent news

The Federal Register

The daily journal of the united states government, request access.

Due to aggressive automated scraping of FederalRegister.gov and eCFR.gov, programmatic access to these sites is limited to access to our extensive developer APIs.

If you are human user receiving this message, we can add your IP address to a set of IPs that can access FederalRegister.gov & eCFR.gov; complete the CAPTCHA (bot test) below and click "Request Access". This process will be necessary for each IP address you wish to access the site from, requests are valid for approximately one quarter (three months) after which the process may need to be repeated.

An official website of the United States government.

If you want to request a wider IP range, first request access for your current IP, and then use the "Site Feedback" button found in the lower left-hand side to make the request.