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• What Is a Research Methodology? | Steps & Tips

What Is a Research Methodology? | Steps & Tips

Published on August 25, 2022 by Shona McCombes and Tegan George. Revised on November 20, 2023.

Your research methodology discusses and explains the data collection and analysis methods you used in your research. A key part of your thesis, dissertation , or research paper , the methodology chapter explains what you did and how you did it, allowing readers to evaluate the reliability and validity of your research and your dissertation topic .

It should include:

• The type of research you conducted
• How you collected and analyzed your data
• Any tools or materials you used in the research
• How you mitigated or avoided research biases
• Why you chose these methods
• Your methodology section should generally be written in the past tense .
• Academic style guides in your field may provide detailed guidelines on what to include for different types of studies.
• Your citation style might provide guidelines for your methodology section (e.g., an APA Style methods section ).

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Table of contents

How to write a research methodology, why is a methods section important, step 1: explain your methodological approach, step 2: describe your data collection methods, step 3: describe your analysis method, step 4: evaluate and justify the methodological choices you made, tips for writing a strong methodology chapter, other interesting articles, frequently asked questions about methodology.

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Your methods section is your opportunity to share how you conducted your research and why you chose the methods you chose. It’s also the place to show that your research was rigorously conducted and can be replicated .

It gives your research legitimacy and situates it within your field, and also gives your readers a place to refer to if they have any questions or critiques in other sections.

You can start by introducing your overall approach to your research. You have two options here.

Option 1: Start with your “what”

What research problem or question did you investigate?

• Aim to describe the characteristics of something?
• Explore an under-researched topic?
• Establish a causal relationship?

And what type of data did you need to achieve this aim?

• Quantitative data , qualitative data , or a mix of both?
• Primary data collected yourself, or secondary data collected by someone else?
• Experimental data gathered by controlling and manipulating variables, or descriptive data gathered via observations?

Option 2: Start with your “why”

Depending on your discipline, you can also start with a discussion of the rationale and assumptions underpinning your methodology. In other words, why did you choose these methods for your study?

• Why is this the best way to answer your research question?
• Is this a standard methodology in your field, or does it require justification?
• Were there any ethical considerations involved in your choices?
• What are the criteria for validity and reliability in this type of research ? How did you prevent bias from affecting your data?

Once you have introduced your reader to your methodological approach, you should share full details about your data collection methods .

Quantitative methods

In order to be considered generalizable, you should describe quantitative research methods in enough detail for another researcher to replicate your study.

Here, explain how you operationalized your concepts and measured your variables. Discuss your sampling method or inclusion and exclusion criteria , as well as any tools, procedures, and materials you used to gather your data.

Surveys Describe where, when, and how the survey was conducted.

• How did you design the questionnaire?
• What form did your questions take (e.g., multiple choice, Likert scale )?
• Were your surveys conducted in-person or virtually?
• What sampling method did you use to select participants?
• What was your sample size and response rate?

Experiments Share full details of the tools, techniques, and procedures you used to conduct your experiment.

• How did you design the experiment ?
• How did you recruit participants?
• How did you manipulate and measure the variables ?
• What tools did you use?

Existing data Explain how you gathered and selected the material (such as datasets or archival data) that you used in your analysis.

• Where did you source the material?
• How was the data originally produced?
• What criteria did you use to select material (e.g., date range)?

The survey consisted of 5 multiple-choice questions and 10 questions measured on a 7-point Likert scale.

The goal was to collect survey responses from 350 customers visiting the fitness apparel company’s brick-and-mortar location in Boston on July 4–8, 2022, between 11:00 and 15:00.

Here, a customer was defined as a person who had purchased a product from the company on the day they took the survey. Participants were given 5 minutes to fill in the survey anonymously. In total, 408 customers responded, but not all surveys were fully completed. Due to this, 371 survey results were included in the analysis.

• Information bias
• Omitted variable bias
• Regression to the mean
• Survivorship bias
• Undercoverage bias
• Sampling bias

Qualitative methods

In qualitative research , methods are often more flexible and subjective. For this reason, it’s crucial to robustly explain the methodology choices you made.

Be sure to discuss the criteria you used to select your data, the context in which your research was conducted, and the role you played in collecting your data (e.g., were you an active participant, or a passive observer?)

Interviews or focus groups Describe where, when, and how the interviews were conducted.

• How did you find and select participants?
• How many participants took part?
• What form did the interviews take ( structured , semi-structured , or unstructured )?
• How long were the interviews?
• How were they recorded?

Participant observation Describe where, when, and how you conducted the observation or ethnography .

• What group or community did you observe? How long did you spend there?
• How did you gain access to this group? What role did you play in the community?
• How long did you spend conducting the research? Where was it located?
• How did you record your data (e.g., audiovisual recordings, note-taking)?

Existing data Explain how you selected case study materials for your analysis.

• What type of materials did you analyze?
• How did you select them?

In order to gain better insight into possibilities for future improvement of the fitness store’s product range, semi-structured interviews were conducted with 8 returning customers.

Here, a returning customer was defined as someone who usually bought products at least twice a week from the store.

Surveys were used to select participants. Interviews were conducted in a small office next to the cash register and lasted approximately 20 minutes each. Answers were recorded by note-taking, and seven interviews were also filmed with consent. One interviewee preferred not to be filmed.

• The Hawthorne effect
• Observer bias
• The placebo effect
• Response bias and Nonresponse bias
• The Pygmalion effect
• Recall bias
• Social desirability bias
• Self-selection bias

Mixed methods

Mixed methods research combines quantitative and qualitative approaches. If a standalone quantitative or qualitative study is insufficient to answer your research question, mixed methods may be a good fit for you.

Mixed methods are less common than standalone analyses, largely because they require a great deal of effort to pull off successfully. If you choose to pursue mixed methods, it’s especially important to robustly justify your methods.

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Next, you should indicate how you processed and analyzed your data. Avoid going into too much detail: you should not start introducing or discussing any of your results at this stage.

In quantitative research , your analysis will be based on numbers. In your methods section, you can include:

• How you prepared the data before analyzing it (e.g., checking for missing data , removing outliers , transforming variables)
• Which software you used (e.g., SPSS, Stata or R)
• Which statistical tests you used (e.g., two-tailed t test , simple linear regression )

In qualitative research, your analysis will be based on language, images, and observations (often involving some form of textual analysis ).

Specific methods might include:

• Content analysis : Categorizing and discussing the meaning of words, phrases and sentences
• Thematic analysis : Coding and closely examining the data to identify broad themes and patterns
• Discourse analysis : Studying communication and meaning in relation to their social context

Mixed methods combine the above two research methods, integrating both qualitative and quantitative approaches into one coherent analytical process.

Above all, your methodology section should clearly make the case for why you chose the methods you did. This is especially true if you did not take the most standard approach to your topic. In this case, discuss why other methods were not suitable for your objectives, and show how this approach contributes new knowledge or understanding.

In any case, it should be overwhelmingly clear to your reader that you set yourself up for success in terms of your methodology’s design. Show how your methods should lead to results that are valid and reliable, while leaving the analysis of the meaning, importance, and relevance of your results for your discussion section .

• Quantitative: Lab-based experiments cannot always accurately simulate real-life situations and behaviors, but they are effective for testing causal relationships between variables .
• Qualitative: Unstructured interviews usually produce results that cannot be generalized beyond the sample group , but they provide a more in-depth understanding of participants’ perceptions, motivations, and emotions.
• Mixed methods: Despite issues systematically comparing differing types of data, a solely quantitative study would not sufficiently incorporate the lived experience of each participant, while a solely qualitative study would be insufficiently generalizable.

Remember that your aim is not just to describe your methods, but to show how and why you applied them. Again, it’s critical to demonstrate that your research was rigorously conducted and can be replicated.

1. Focus on your objectives and research questions

The methodology section should clearly show why your methods suit your objectives and convince the reader that you chose the best possible approach to answering your problem statement and research questions .

2. Cite relevant sources

Your methodology can be strengthened by referencing existing research in your field. This can help you to:

• Show that you followed established practice for your type of research
• Discuss how you decided on your approach by evaluating existing research
• Present a novel methodological approach to address a gap in the literature

3. Write for your audience

Consider how much information you need to give, and avoid getting too lengthy. If you are using methods that are standard for your discipline, you probably don’t need to give a lot of background or justification.

Regardless, your methodology should be a clear, well-structured text that makes an argument for your approach, not just a list of technical details and procedures.

If you want to know more about statistics , methodology , or research bias , make sure to check out some of our other articles with explanations and examples.

• Normal distribution
• Measures of central tendency
• Chi square tests
• Confidence interval
• Quartiles & Quantiles

Methodology

• Cluster sampling
• Stratified sampling
• Thematic analysis
• Cohort study
• Peer review
• Ethnography

Research bias

• Implicit bias
• Cognitive bias
• Conformity bias
• Hawthorne effect
• Availability heuristic
• Attrition bias

Methodology refers to the overarching strategy and rationale of your research project . It involves studying the methods used in your field and the theories or principles behind them, in order to develop an approach that matches your objectives.

Methods are the specific tools and procedures you use to collect and analyze data (for example, experiments, surveys , and statistical tests ).

In shorter scientific papers, where the aim is to report the findings of a specific study, you might simply describe what you did in a methods section .

In a longer or more complex research project, such as a thesis or dissertation , you will probably include a methodology section , where you explain your approach to answering the research questions and cite relevant sources to support your choice of methods.

In a scientific paper, the methodology always comes after the introduction and before the results , discussion and conclusion . The same basic structure also applies to a thesis, dissertation , or research proposal .

Depending on the length and type of document, you might also include a literature review or theoretical framework before the methodology.

Quantitative research deals with numbers and statistics, while qualitative research deals with words and meanings.

Quantitative methods allow you to systematically measure variables and test hypotheses . Qualitative methods allow you to explore concepts and experiences in more detail.

Reliability and validity are both about how well a method measures something:

• Reliability refers to the  consistency of a measure (whether the results can be reproduced under the same conditions).
• Validity   refers to the  accuracy of a measure (whether the results really do represent what they are supposed to measure).

If you are doing experimental research, you also have to consider the internal and external validity of your experiment.

A sample is a subset of individuals from a larger population . Sampling means selecting the group that you will actually collect data from in your research. For example, if you are researching the opinions of students in your university, you could survey a sample of 100 students.

In statistics, sampling allows you to test a hypothesis about the characteristics of a population.

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Blog Case Study

How to Present a Case Study like a Pro (With Examples)

By Danesh Ramuthi , Sep 07, 2023

Okay, let’s get real: case studies can be kinda snooze-worthy. But guess what? They don’t have to be!

In this article, I will cover every element that transforms a mere report into a compelling case study, from selecting the right metrics to using persuasive narrative techniques.

And if you’re feeling a little lost, don’t worry! There are cool tools like Venngage’s Case Study Creator to help you whip up something awesome, even if you’re short on time. Plus, the pre-designed case study templates are like instant polish because let’s be honest, everyone loves a shortcut.

Click to jump ahead: 

What is a case study presentation?

What is the purpose of presenting a case study, how to structure a case study presentation, how long should a case study presentation be, 5 case study presentation examples with templates, 6 tips for delivering an effective case study presentation, 5 common mistakes to avoid in a case study presentation, how to present a case study faqs.

A case study presentation involves a comprehensive examination of a specific subject, which could range from an individual, group, location, event, organization or phenomenon.

They’re like puzzles you get to solve with the audience, all while making you think outside the box.

Unlike a basic report or whitepaper, the purpose of a case study presentation is to stimulate critical thinking among the viewers. 

The primary objective of a case study is to provide an extensive and profound comprehension of the chosen topic. You don’t just throw numbers at your audience. You use examples and real-life cases to make you think and see things from different angles.

The primary purpose of presenting a case study is to offer a comprehensive, evidence-based argument that informs, persuades and engages your audience.

Here’s the juicy part: presenting that case study can be your secret weapon. Whether you’re pitching a groundbreaking idea to a room full of suits or trying to impress your professor with your A-game, a well-crafted case study can be the magic dust that sprinkles brilliance over your words.

Think of it like digging into a puzzle you can’t quite crack . A case study lets you explore every piece, turn it over and see how it fits together. This close-up look helps you understand the whole picture, not just a blurry snapshot.

It’s also your chance to showcase how you analyze things, step by step, until you reach a conclusion. It’s all about being open and honest about how you got there.

Besides, presenting a case study gives you an opportunity to connect data and real-world scenarios in a compelling narrative. It helps to make your argument more relatable and accessible, increasing its impact on your audience.

One of the contexts where case studies can be very helpful is during the job interview. In some job interviews, you as candidates may be asked to present a case study as part of the selection process.

Having a case study presentation prepared allows the candidate to demonstrate their ability to understand complex issues, formulate strategies and communicate their ideas effectively.

The way you present a case study can make all the difference in how it’s received. A well-structured presentation not only holds the attention of your audience but also ensures that your key points are communicated clearly and effectively.

In this section, let’s go through the key steps that’ll help you structure your case study presentation for maximum impact.

Let’s get into it. 

Open with an introductory overview 

Start by introducing the subject of your case study and its relevance. Explain why this case study is important and who would benefit from the insights gained. This is your opportunity to grab your audience’s attention.

Explain the problem in question

Dive into the problem or challenge that the case study focuses on. Provide enough background information for the audience to understand the issue. If possible, quantify the problem using data or metrics to show the magnitude or severity.

Detail the solutions to solve the problem

After outlining the problem, describe the steps taken to find a solution. This could include the methodology, any experiments or tests performed and the options that were considered. Make sure to elaborate on why the final solution was chosen over the others.

Key stakeholders Involved

Talk about the individuals, groups or organizations that were directly impacted by or involved in the problem and its solution. 

Stakeholders may experience a range of outcomes—some may benefit, while others could face setbacks.

For example, in a business transformation case study, employees could face job relocations or changes in work culture, while shareholders might be looking at potential gains or losses.

Discuss the key results & outcomes

Discuss the results of implementing the solution. Use data and metrics to back up your statements. Did the solution meet its objectives? What impact did it have on the stakeholders? Be honest about any setbacks or areas for improvement as well.

Include visuals to support your analysis

Visual aids can be incredibly effective in helping your audience grasp complex issues. Utilize charts, graphs, images or video clips to supplement your points. Make sure to explain each visual and how it contributes to your overall argument.

Pie charts illustrate the proportion of different components within a whole, useful for visualizing market share, budget allocation or user demographics.

This is particularly useful especially if you’re displaying survey results in your case study presentation.

Stacked charts on the other hand are perfect for visualizing composition and trends. This is great for analyzing things like customer demographics, product breakdowns or budget allocation in your case study.

Consider this example of a stacked bar chart template. It provides a straightforward summary of the top-selling cake flavors across various locations, offering a quick and comprehensive view of the data.

Not the chart you’re looking for? Browse Venngage’s gallery of chart templates to find the perfect one that’ll captivate your audience and level up your data storytelling.

Recommendations and next steps

Wrap up by providing recommendations based on the case study findings. Outline the next steps that stakeholders should take to either expand on the success of the project or address any remaining challenges.

Acknowledgments and references

Thank the people who contributed to the case study and helped in the problem-solving process. Cite any external resources, reports or data sets that contributed to your analysis.

Feedback & Q&A session

Open the floor for questions and feedback from your audience. This allows for further discussion and can provide additional insights that may not have been considered previously.

Closing remarks

Conclude the presentation by summarizing the key points and emphasizing the takeaways. Thank your audience for their time and participation and express your willingness to engage in further discussions or collaborations on the subject.

Well, the length of a case study presentation can vary depending on the complexity of the topic and the needs of your audience. However, a typical business or academic presentation often lasts between 15 to 30 minutes. 

This time frame usually allows for a thorough explanation of the case while maintaining audience engagement. However, always consider leaving a few minutes at the end for a Q&A session to address any questions or clarify points made during the presentation.

When it comes to presenting a compelling case study, having a well-structured template can be a game-changer. 

It helps you organize your thoughts, data and findings in a coherent and visually pleasing manner. 

Not all case studies are created equal and different scenarios require distinct approaches for maximum impact. 

To save you time and effort, I have curated a list of 5 versatile case study presentation templates, each designed for specific needs and audiences. 

Here are some best case study presentation examples that showcase effective strategies for engaging your audience and conveying complex information clearly.

1 . Lab report case study template

Ever feel like your research gets lost in a world of endless numbers and jargon? Lab case studies are your way out!

Think of it as building a bridge between your cool experiment and everyone else. It’s more than just reporting results – it’s explaining the “why” and “how” in a way that grabs attention and makes sense.

This lap report template acts as a blueprint for your report, guiding you through each essential section (introduction, methods, results, etc.) in a logical order.

Want to present your research like a pro? Browse our research presentation template gallery for creative inspiration!

2. Product case study template

It’s time you ditch those boring slideshows and bullet points because I’ve got a better way to win over clients: product case study templates.

Instead of just listing features and benefits, you get to create a clear and concise story that shows potential clients exactly what your product can do for them. It’s like painting a picture they can easily visualize, helping them understand the value your product brings to the table.

Grab the template below, fill in the details, and watch as your product’s impact comes to life!

3. Content marketing case study template

In digital marketing, showcasing your accomplishments is as vital as achieving them. 

A well-crafted case study not only acts as a testament to your successes but can also serve as an instructional tool for others. 

With this coral content marketing case study template—a perfect blend of vibrant design and structured documentation, you can narrate your marketing triumphs effectively.

4. Case study psychology template

Understanding how people tick is one of psychology’s biggest quests and case studies are like magnifying glasses for the mind. They offer in-depth looks at real-life behaviors, emotions and thought processes, revealing fascinating insights into what makes us human.

Writing a top-notch case study, though, can be a challenge. It requires careful organization, clear presentation and meticulous attention to detail. That’s where a good case study psychology template comes in handy.

Think of it as a helpful guide, taking care of formatting and structure while you focus on the juicy content. No more wrestling with layouts or margins – just pour your research magic into crafting a compelling narrative.

5. Lead generation case study template

Lead generation can be a real head-scratcher. But here’s a little help: a lead generation case study.

Think of it like a friendly handshake and a confident resume all rolled into one. It’s your chance to showcase your expertise, share real-world successes and offer valuable insights. Potential clients get to see your track record, understand your approach and decide if you’re the right fit.

No need to start from scratch, though. This lead generation case study template guides you step-by-step through crafting a clear, compelling narrative that highlights your wins and offers actionable tips for others. Fill in the gaps with your specific data and strategies, and voilà! You’ve got a powerful tool to attract new customers.

Related: 15+ Professional Case Study Examples [Design Tips + Templates]

So, you’ve spent hours crafting the perfect case study and are now tasked with presenting it. Crafting the case study is only half the battle; delivering it effectively is equally important. 

Whether you’re facing a room of executives, academics or potential clients, how you present your findings can make a significant difference in how your work is received. 

Forget boring reports and snooze-inducing presentations! Let’s make your case study sing. Here are some key pointers to turn information into an engaging and persuasive performance:

• Know your audience : Tailor your presentation to the knowledge level and interests of your audience. Remember to use language and examples that resonate with them.
• Rehearse : Rehearsing your case study presentation is the key to a smooth delivery and for ensuring that you stay within the allotted time. Practice helps you fine-tune your pacing, hone your speaking skills with good word pronunciations and become comfortable with the material, leading to a more confident, conversational and effective presentation.
• Start strong : Open with a compelling introduction that grabs your audience’s attention. You might want to use an interesting statistic, a provocative question or a brief story that sets the stage for your case study.
• Be clear and concise : Avoid jargon and overly complex sentences. Get to the point quickly and stay focused on your objectives.
• Use visual aids : Incorporate slides with graphics, charts or videos to supplement your verbal presentation. Make sure they are easy to read and understand.
• Tell a story : Use storytelling techniques to make the case study more engaging. A well-told narrative can help you make complex data more relatable and easier to digest.

Ditching the dry reports and slide decks? Venngage’s case study templates let you wow customers with your solutions and gain insights to improve your business plan. Pre-built templates, visual magic and customer captivation – all just a click away. Go tell your story and watch them say “wow!”

Nailed your case study, but want to make your presentation even stronger? Avoid these common mistakes to ensure your audience gets the most out of it:

Overloading with information

A case study is not an encyclopedia. Overloading your presentation with excessive data, text or jargon can make it cumbersome and difficult for the audience to digest the key points. Stick to what’s essential and impactful. Need help making your data clear and impactful? Our data presentation templates can help! Find clear and engaging visuals to showcase your findings.

Lack of structure

Jumping haphazardly between points or topics can confuse your audience. A well-structured presentation, with a logical flow from introduction to conclusion, is crucial for effective communication.

Ignoring the audience

Different audiences have different needs and levels of understanding. Failing to adapt your presentation to your audience can result in a disconnect and a less impactful presentation.

Poor visual elements

While content is king, poor design or lack of visual elements can make your case study dull or hard to follow. Make sure you use high-quality images, graphs and other visual aids to support your narrative.

Not focusing on results

A case study aims to showcase a problem and its solution, but what most people care about are the results. Failing to highlight or adequately explain the outcomes can make your presentation fall flat.

How to start a case study presentation?

Starting a case study presentation effectively involves a few key steps:

• Grab attention : Open with a hook—an intriguing statistic, a provocative question or a compelling visual—to engage your audience from the get-go.
• Set the stage : Briefly introduce the subject, context and relevance of the case study to give your audience an idea of what to expect.
• Outline objectives : Clearly state what the case study aims to achieve. Are you solving a problem, proving a point or showcasing a success?
• Agenda : Give a quick outline of the key sections or topics you’ll cover to help the audience follow along.
• Set expectations : Let your audience know what you want them to take away from the presentation, whether it’s knowledge, inspiration or a call to action.

How to present a case study on PowerPoint and on Google Slides?

Presenting a case study on PowerPoint and Google Slides involves a structured approach for clarity and impact using presentation slides :

• Title slide : Start with a title slide that includes the name of the case study, your name and any relevant institutional affiliations.
• Introduction : Follow with a slide that outlines the problem or situation your case study addresses. Include a hook to engage the audience.
• Objectives : Clearly state the goals of the case study in a dedicated slide.
• Findings : Use charts, graphs and bullet points to present your findings succinctly.
• Analysis : Discuss what the findings mean, drawing on supporting data or secondary research as necessary.
• Conclusion : Summarize key takeaways and results.
• Q&A : End with a slide inviting questions from the audience.

What’s the role of analysis in a case study presentation?

The role of analysis in a case study presentation is to interpret the data and findings, providing context and meaning to them. 

It helps your audience understand the implications of the case study, connects the dots between the problem and the solution and may offer recommendations for future action.

Is it important to include real data and results in the presentation?

Yes, including real data and results in a case study presentation is crucial to show experience,  credibility and impact. Authentic data lends weight to your findings and conclusions, enabling the audience to trust your analysis and take your recommendations more seriously

How do I conclude a case study presentation effectively?

To conclude a case study presentation effectively, summarize the key findings, insights and recommendations in a clear and concise manner. 

End with a strong call-to-action or a thought-provoking question to leave a lasting impression on your audience.

What’s the best way to showcase data in a case study presentation ?

The best way to showcase data in a case study presentation is through visual aids like charts, graphs and infographics which make complex information easily digestible, engaging and creative. 

Don’t just report results, visualize them! This template for example lets you transform your social media case study into a captivating infographic that sparks conversation.

Choose the type of visual that best represents the data you’re showing; for example, use bar charts for comparisons or pie charts for parts of a whole. 

Ensure that the visuals are high-quality and clearly labeled, so the audience can quickly grasp the key points. 

Keep the design consistent and simple, avoiding clutter or overly complex visuals that could distract from the message.

Choose a template that perfectly suits your case study where you can utilize different visual aids for maximum impact. 

Need more inspiration on how to turn numbers into impact with the help of infographics? Our ready-to-use infographic templates take the guesswork out of creating visual impact for your case studies with just a few clicks.

Related: 10+ Case Study Infographic Templates That Convert

Congrats on mastering the art of compelling case study presentations! This guide has equipped you with all the essentials, from structure and nuances to avoiding common pitfalls. You’re ready to impress any audience, whether in the boardroom, the classroom or beyond.

And remember, you’re not alone in this journey. Venngage’s Case Study Creator is your trusty companion, ready to elevate your presentations from ordinary to extraordinary. So, let your confidence shine, leverage your newly acquired skills and prepare to deliver presentations that truly resonate.

Go forth and make a lasting impact!

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Home » Case Study – Methods, Examples and Guide

Case Study – Methods, Examples and Guide

Table of Contents

A case study is a research method that involves an in-depth examination and analysis of a particular phenomenon or case, such as an individual, organization, community, event, or situation.

It is a qualitative research approach that aims to provide a detailed and comprehensive understanding of the case being studied. Case studies typically involve multiple sources of data, including interviews, observations, documents, and artifacts, which are analyzed using various techniques, such as content analysis, thematic analysis, and grounded theory. The findings of a case study are often used to develop theories, inform policy or practice, or generate new research questions.

Types of Case Study

Types and Methods of Case Study are as follows:

Single-Case Study

A single-case study is an in-depth analysis of a single case. This type of case study is useful when the researcher wants to understand a specific phenomenon in detail.

For Example , A researcher might conduct a single-case study on a particular individual to understand their experiences with a particular health condition or a specific organization to explore their management practices. The researcher collects data from multiple sources, such as interviews, observations, and documents, and uses various techniques to analyze the data, such as content analysis or thematic analysis. The findings of a single-case study are often used to generate new research questions, develop theories, or inform policy or practice.

Multiple-Case Study

A multiple-case study involves the analysis of several cases that are similar in nature. This type of case study is useful when the researcher wants to identify similarities and differences between the cases.

For Example, a researcher might conduct a multiple-case study on several companies to explore the factors that contribute to their success or failure. The researcher collects data from each case, compares and contrasts the findings, and uses various techniques to analyze the data, such as comparative analysis or pattern-matching. The findings of a multiple-case study can be used to develop theories, inform policy or practice, or generate new research questions.

Exploratory Case Study

An exploratory case study is used to explore a new or understudied phenomenon. This type of case study is useful when the researcher wants to generate hypotheses or theories about the phenomenon.

For Example, a researcher might conduct an exploratory case study on a new technology to understand its potential impact on society. The researcher collects data from multiple sources, such as interviews, observations, and documents, and uses various techniques to analyze the data, such as grounded theory or content analysis. The findings of an exploratory case study can be used to generate new research questions, develop theories, or inform policy or practice.

Descriptive Case Study

A descriptive case study is used to describe a particular phenomenon in detail. This type of case study is useful when the researcher wants to provide a comprehensive account of the phenomenon.

For Example, a researcher might conduct a descriptive case study on a particular community to understand its social and economic characteristics. The researcher collects data from multiple sources, such as interviews, observations, and documents, and uses various techniques to analyze the data, such as content analysis or thematic analysis. The findings of a descriptive case study can be used to inform policy or practice or generate new research questions.

Instrumental Case Study

An instrumental case study is used to understand a particular phenomenon that is instrumental in achieving a particular goal. This type of case study is useful when the researcher wants to understand the role of the phenomenon in achieving the goal.

For Example, a researcher might conduct an instrumental case study on a particular policy to understand its impact on achieving a particular goal, such as reducing poverty. The researcher collects data from multiple sources, such as interviews, observations, and documents, and uses various techniques to analyze the data, such as content analysis or thematic analysis. The findings of an instrumental case study can be used to inform policy or practice or generate new research questions.

Case Study Data Collection Methods

Here are some common data collection methods for case studies:

Interviews involve asking questions to individuals who have knowledge or experience relevant to the case study. Interviews can be structured (where the same questions are asked to all participants) or unstructured (where the interviewer follows up on the responses with further questions). Interviews can be conducted in person, over the phone, or through video conferencing.

Observations

Observations involve watching and recording the behavior and activities of individuals or groups relevant to the case study. Observations can be participant (where the researcher actively participates in the activities) or non-participant (where the researcher observes from a distance). Observations can be recorded using notes, audio or video recordings, or photographs.

Documents can be used as a source of information for case studies. Documents can include reports, memos, emails, letters, and other written materials related to the case study. Documents can be collected from the case study participants or from public sources.

Surveys involve asking a set of questions to a sample of individuals relevant to the case study. Surveys can be administered in person, over the phone, through mail or email, or online. Surveys can be used to gather information on attitudes, opinions, or behaviors related to the case study.

Artifacts are physical objects relevant to the case study. Artifacts can include tools, equipment, products, or other objects that provide insights into the case study phenomenon.

How to conduct Case Study Research

Conducting a case study research involves several steps that need to be followed to ensure the quality and rigor of the study. Here are the steps to conduct case study research:

• Define the research questions: The first step in conducting a case study research is to define the research questions. The research questions should be specific, measurable, and relevant to the case study phenomenon under investigation.
• Select the case: The next step is to select the case or cases to be studied. The case should be relevant to the research questions and should provide rich and diverse data that can be used to answer the research questions.
• Collect data: Data can be collected using various methods, such as interviews, observations, documents, surveys, and artifacts. The data collection method should be selected based on the research questions and the nature of the case study phenomenon.
• Analyze the data: The data collected from the case study should be analyzed using various techniques, such as content analysis, thematic analysis, or grounded theory. The analysis should be guided by the research questions and should aim to provide insights and conclusions relevant to the research questions.
• Draw conclusions: The conclusions drawn from the case study should be based on the data analysis and should be relevant to the research questions. The conclusions should be supported by evidence and should be clearly stated.
• Validate the findings: The findings of the case study should be validated by reviewing the data and the analysis with participants or other experts in the field. This helps to ensure the validity and reliability of the findings.
• Write the report: The final step is to write the report of the case study research. The report should provide a clear description of the case study phenomenon, the research questions, the data collection methods, the data analysis, the findings, and the conclusions. The report should be written in a clear and concise manner and should follow the guidelines for academic writing.

Examples of Case Study

Here are some examples of case study research:

• The Hawthorne Studies : Conducted between 1924 and 1932, the Hawthorne Studies were a series of case studies conducted by Elton Mayo and his colleagues to examine the impact of work environment on employee productivity. The studies were conducted at the Hawthorne Works plant of the Western Electric Company in Chicago and included interviews, observations, and experiments.
• The Stanford Prison Experiment: Conducted in 1971, the Stanford Prison Experiment was a case study conducted by Philip Zimbardo to examine the psychological effects of power and authority. The study involved simulating a prison environment and assigning participants to the role of guards or prisoners. The study was controversial due to the ethical issues it raised.
• The Challenger Disaster: The Challenger Disaster was a case study conducted to examine the causes of the Space Shuttle Challenger explosion in 1986. The study included interviews, observations, and analysis of data to identify the technical, organizational, and cultural factors that contributed to the disaster.
• The Enron Scandal: The Enron Scandal was a case study conducted to examine the causes of the Enron Corporation’s bankruptcy in 2001. The study included interviews, analysis of financial data, and review of documents to identify the accounting practices, corporate culture, and ethical issues that led to the company’s downfall.
• The Fukushima Nuclear Disaster : The Fukushima Nuclear Disaster was a case study conducted to examine the causes of the nuclear accident that occurred at the Fukushima Daiichi Nuclear Power Plant in Japan in 2011. The study included interviews, analysis of data, and review of documents to identify the technical, organizational, and cultural factors that contributed to the disaster.

Application of Case Study

Case studies have a wide range of applications across various fields and industries. Here are some examples:

Business and Management

Case studies are widely used in business and management to examine real-life situations and develop problem-solving skills. Case studies can help students and professionals to develop a deep understanding of business concepts, theories, and best practices.

Case studies are used in healthcare to examine patient care, treatment options, and outcomes. Case studies can help healthcare professionals to develop critical thinking skills, diagnose complex medical conditions, and develop effective treatment plans.

Case studies are used in education to examine teaching and learning practices. Case studies can help educators to develop effective teaching strategies, evaluate student progress, and identify areas for improvement.

Social Sciences

Case studies are widely used in social sciences to examine human behavior, social phenomena, and cultural practices. Case studies can help researchers to develop theories, test hypotheses, and gain insights into complex social issues.

Law and Ethics

Case studies are used in law and ethics to examine legal and ethical dilemmas. Case studies can help lawyers, policymakers, and ethical professionals to develop critical thinking skills, analyze complex cases, and make informed decisions.

Purpose of Case Study

The purpose of a case study is to provide a detailed analysis of a specific phenomenon, issue, or problem in its real-life context. A case study is a qualitative research method that involves the in-depth exploration and analysis of a particular case, which can be an individual, group, organization, event, or community.

The primary purpose of a case study is to generate a comprehensive and nuanced understanding of the case, including its history, context, and dynamics. Case studies can help researchers to identify and examine the underlying factors, processes, and mechanisms that contribute to the case and its outcomes. This can help to develop a more accurate and detailed understanding of the case, which can inform future research, practice, or policy.

Case studies can also serve other purposes, including:

• Illustrating a theory or concept: Case studies can be used to illustrate and explain theoretical concepts and frameworks, providing concrete examples of how they can be applied in real-life situations.
• Developing hypotheses: Case studies can help to generate hypotheses about the causal relationships between different factors and outcomes, which can be tested through further research.
• Providing insight into complex issues: Case studies can provide insights into complex and multifaceted issues, which may be difficult to understand through other research methods.
• Informing practice or policy: Case studies can be used to inform practice or policy by identifying best practices, lessons learned, or areas for improvement.

Advantages of Case Study Research

There are several advantages of case study research, including:

• In-depth exploration: Case study research allows for a detailed exploration and analysis of a specific phenomenon, issue, or problem in its real-life context. This can provide a comprehensive understanding of the case and its dynamics, which may not be possible through other research methods.
• Rich data: Case study research can generate rich and detailed data, including qualitative data such as interviews, observations, and documents. This can provide a nuanced understanding of the case and its complexity.
• Holistic perspective: Case study research allows for a holistic perspective of the case, taking into account the various factors, processes, and mechanisms that contribute to the case and its outcomes. This can help to develop a more accurate and comprehensive understanding of the case.
• Theory development: Case study research can help to develop and refine theories and concepts by providing empirical evidence and concrete examples of how they can be applied in real-life situations.
• Practical application: Case study research can inform practice or policy by identifying best practices, lessons learned, or areas for improvement.
• Contextualization: Case study research takes into account the specific context in which the case is situated, which can help to understand how the case is influenced by the social, cultural, and historical factors of its environment.

Limitations of Case Study Research

There are several limitations of case study research, including:

• Limited generalizability : Case studies are typically focused on a single case or a small number of cases, which limits the generalizability of the findings. The unique characteristics of the case may not be applicable to other contexts or populations, which may limit the external validity of the research.
• Biased sampling: Case studies may rely on purposive or convenience sampling, which can introduce bias into the sample selection process. This may limit the representativeness of the sample and the generalizability of the findings.
• Subjectivity: Case studies rely on the interpretation of the researcher, which can introduce subjectivity into the analysis. The researcher’s own biases, assumptions, and perspectives may influence the findings, which may limit the objectivity of the research.
• Limited control: Case studies are typically conducted in naturalistic settings, which limits the control that the researcher has over the environment and the variables being studied. This may limit the ability to establish causal relationships between variables.
• Time-consuming: Case studies can be time-consuming to conduct, as they typically involve a detailed exploration and analysis of a specific case. This may limit the feasibility of conducting multiple case studies or conducting case studies in a timely manner.
• Resource-intensive: Case studies may require significant resources, including time, funding, and expertise. This may limit the ability of researchers to conduct case studies in resource-constrained settings.

About the author

Muhammad Hassan

Researcher, Academic Writer, Web developer

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Your Step-By-Step Guide To Writing a Case Study

Creating a case study is both an art and a science. It requires making an in-depth exploration of your chosen subject in order to extract meaningful insights and understand the dynamics that more general surveys or statistical research might not uncover. At the same time, your case study also needs to be a compelling read to ensure those insights get attention from other people!

Unsurprisingly, the prospect of crafting an effective case study can be daunting. It calls for strategic planning, careful organization, and clear communication, all of which can be challenging even for experienced researchers. That's why we've created this step-by-step guide, which breaks the process down into manageable steps, demystifying the journey from defining your research question to sharing your findings. Whether you're a seasoned researcher or a first-timer, this guide aims to equip you with the necessary tools and tips to create a case study that's not just informative, but also engaging and impactful.

Are you ready to unlock the potential of case studies? Let's dive in!

What is a case study?

First, it's important to understand what a case study is – and what it isn't.

A case study is a thorough exploration of a specific subject or event over a certain time frame. Case studies are utilized in numerous fields, including sociology, psychology, education, anthropology, business, and the health sciences, and employ various research techniques to shed light on complex issues.

A case study does not provide absolute proof or conclusions that can be universally applied. Because it concentrates on one particular case or just a few cases, the findings might not apply to different contexts or subjects. Case studies also aren't ideal for determining cause-and-effect relationships as they do not use controlled conditions to separate and measure the impacts of different factors. Lastly, it must be said that a case study isn't just a random assortment of facts or observations; it necessitates a clear research question, a methodical approach to data collection and analysis, and a thoughtful interpretation of the results.

Getting started

Now that we've established the definition and purpose of a case study, let's explore the process by which one is created. You can produce a case study by following these nine steps:

1. Define the purpose of your case study

Before you start writing a case study, you need to define its purpose clearly. Ask yourself: What is the research question or problem you aim to solve? What insights are you looking to uncover? Your goals will guide your research design and influence your choice of case. This initial stage of introspection and clarification is crucial as it acts as a roadmap for your study.

2. Select the case to study

Once you've defined your research objective, the next step is to choose a suitable case that can help answer your research question. This might be a unique, critical, or representative instance. Unique cases offer the opportunity to observe and analyze a situation that is unusual or not well-understood. In contrast, a representative or typical case is often chosen because it represents other cases or a broader phenomenon.

In any case, be sure to justify your choice. Explain why the case is of interest and how it can contribute to the knowledge or understanding of the issue at hand. For instance, if you're studying the effects of corporate restructuring on employee morale, you might choose to focus on a company that recently underwent a significant restructure.

3. Conduct a thorough literature review

Performing a literature review involves a careful examination of relevant scholarly articles, books, and other sources related to your research question or problem. In the process, you identify gaps in the current knowledge and determine how your case study can address them. By critically examining existing research, you will not only gain a comprehensive understanding of your chosen topic but also be able to refine your research question or hypothesis, if necessary.

4. Choose a methodological approach

The methodological approach used in your case study will depend on your research objectives and the nature of the case. Methodologies that can be employed in case studies include qualitative, quantitative, and mixed methods .

Qualitative methods are often used when the goal is to explore, understand, or interpret certain phenomena. These involve approaches like interviews, focus groups, or ethnography. Quantitative methods, on the other hand, are used when the goal is to test hypotheses or examine relationships between variables. Quantitative approaches often include experiments. Also, surveys may be either qualitative or quantitative depending on the question design.

You may choose to use a combination of qualitative and quantitative methods (mixed methods) if it suits your research objectives.

5. Collect and organize your data

Data collection should be systematic and organized to maintain the integrity and reliability of your research. You need to plan how you will record and store your data to ensure that it's accessible and usable.

If you're conducting interviews or observations, consider using recording devices (with participant consent) to capture the data accurately. In addition, you may want to transcribe the recorded material for easier analysis. If you're using documents or archival records, develop a system for coding and categorizing the data.

6. Analyze the data

Analysis involves interpreting your data to draw out meaningful insights; it is in this stage that your findings start to take shape. Depending on the nature of your data and your research question, you might use any of a variety of analysis methods. For qualitative data, you might employ thematic analysis to identify key themes or grounded theory to generate a new theoretical framework. For quantitative data, you might use statistical analysis to identify patterns or correlations.

Always be open to unexpected findings. Your initial hypotheses might not be supported, or you might uncover new insights that you hadn't initially considered. Remember that all data, whether they fit neatly into your analysis or not, provide valuable insights and contribute to the holistic understanding of your case.

7. Write the case study report

After analyzing the data, it's finally time to compose your case study. In terms of structure, a typical case study might consist of an introduction, background information, the collected data (results), analysis of that data, and the conclusion. Here's a brief breakdown of each section:

• Introduction: The introduction should be brief but engaging, providing a clear statement of the research question or problem, explaining why the case was chosen, and outlining what the case study will cover.
• Background: The background provides the context for your case. Describe the case, its history, and any relevant information that will help readers understand the situation.
• Results: This section should provide a comprehensive account of what you found, without interpretation or opinion. Present your findings in a clear, organized manner. Use visuals such as charts or graphs if they aid comprehension.
• Analysis: This section should provide your interpretations and arguments. Discuss the patterns, themes, or relationships you've identified in your data. Explain what these findings mean in relation to your research question.
• Conclusion: Finally, summarize the key insights from your case study along with their implications. Discuss the limitations of your study and propose avenues for future research.

8. Review and revise

The process of writing a case study doesn't actually end when the report is written; you also need to review your writing for coherence, clarity, and correctness. Don't underestimate the importance of this step! Make sure the information flows logically and that your arguments are well-supported. Check for any grammar or spelling errors. Having a peer or mentor review your work can be incredibly helpful as they provide a fresh perspective and can catch mistakes you might have missed.

9. Get approval if required

If your case study involves human subjects, you may need to obtain approval from an ethical review board. You'll also need to obtain informed consent from your subjects and ensure you respect their privacy and confidentiality throughout the research process. Always follow your institution's ethical guidelines and any other relevant legislation .

Practical tips for writing a compelling case study

Getting through all those steps can feel like a formidable challenge, but here are some practical tips to make the process more manageable:

Be systematic and organized

Given the importance of detail in case studies, it's vital to be systematic and organized from the get-go. This means keeping meticulous records of your data, your sources, and any changes to your research design. A good practice is to maintain a research journal or log where you can record your process, thoughts, and reflections.

In addition, use technology to your advantage. Digital tools like citation managers can help you keep track of your sources and make formatting references a breeze, while spreadsheet or database software can assist in managing and organizing your data. Developing a consistent system for labeling and storing information at the outset will save you time and effort later when you need to retrieve data for analysis.

Stay focused

One common pitfall in research and writing is loss of focus: getting sidetracked by interesting but ultimately irrelevant digressions, which can be very easy, especially when you're dealing with a rich and complex case. Always remember your research question and objectives, and let these guide your study at every step. It's perfectly acceptable – and in fact advisable – to delineate what your study will not cover. Setting clear boundaries can help you stay focused and manage the scope of your study effectively.

Use visual aids

Visual aids such as charts, diagrams, or photographs can greatly enhance your case study. They provide readers with a break from the monotony of text and can communicate complex data or relationships more easily. For instance, if you're presenting a lot of numerical data, consider using a chart or graph. If you're describing a process or sequence of events, portraying it in a flowchart or timeline might be useful. Remember, the goal is to aid comprehension, so make sure your visual aids are clear, well-labeled, and integrated into the text.

Include direct quotes

If your case study involves interviews, including direct quotes can add depth and a sense of the personal to your findings. They provide readers with a firsthand perspective and make your case study more engaging.

When using quotes, be sure to integrate them smoothly into your text. Provide enough context so readers understand the quote's relevance. Also, remember to adhere to ethical guidelines– always respect confidentiality and anonymity agreements.

Maintain ethical standards

Ethics is a fundamental consideration in all research, including case studies. Ensure you have proper consent from participants, respect their privacy, and accurately present your findings without manipulation.

Misrepresenting data or failing to respect participants' rights can lead to serious ethical violations. Always follow your institution's ethical guidelines and any other relevant legislation. If in doubt, seek advice from a supervisor or your institution's ethics committee.

Acknowledge limitations

Every research study has limitations, which could relate to the research design, data collection methods, or other aspects of the study. Being transparent about the limitations of your study can enhance its credibility; moreover, not only does identifying limitations demonstrate your critical thinking and honesty, but it also helps readers accurately interpret your findings.

Finally, acknowledging the limitations of your work helps to set the stage for further research. By identifying aspects that your study couldn't address, you provide other researchers with avenues for building on your findings.

Learn from examples

Before you start writing your case study, it can be helpful to review some published case studies in your field. Different fields may have different conventions, and familiarizing yourself with case studies in your own field can help guide your writing. Look at the structure, tone, and style. Pay attention to how the authors present and analyze data, and how they link their findings back to the research question. You can also learn a lot from the strengths and weaknesses of previously published works. However, remember to develop your own unique voice and perspective – don't just mimic what others have done.

Design for triangulation

Triangulation involves using multiple data sources or methods to gain a more comprehensive and balanced understanding of your research topic. By coming at your research question from multiple directions, such as by examining different datasets or using different methods, you can increase the validity of your results and gain more nuanced insights.

For example, if you're studying the impact of a new teaching method in a school, you might observe classes, interview teachers, and also survey students. Each method will provide a slightly different perspective, and together, they allow you to develop a more complete picture of the teaching method's impact.

Practice reflexivity

Reflexivity involves reflecting on how your assumptions, values, or experiences might influence your research process and interpretations. As a researcher, it's essential to be aware of your potential biases and how they might shape your study.

Consider keeping a reflexivity journal where you can note your thoughts, feelings, and reflections throughout the research process. This practice can help you stay aware of your biases and ensure your research is as objective and balanced as possible.

Write for your audience

Always make sure that your writing is on target for your intended audience. If you're writing for an academic audience, for example, you'll likely use a more formal tone and include more detailed methodological information. If you're writing for practitioners or a general audience, you might use a more accessible language and focus more on practical implications.

Remember to define any technical terms or jargon, and provide sufficient context so your readers can understand your research. The goal is to communicate your findings effectively, regardless of who your readers are.

Seek feedback

Feedback is valuable for improving your case study. Consider sharing drafts with your peers, mentors, or supervisors and asking for their input. Fresh eyes can provide different perspectives, catch errors, or suggest ways to strengthen your arguments.

Remember, feedback is not personal; it's about improving your work. Be open to critique and willing to revise your work based on the feedback you receive.

Writing a case study is a meticulous process that requires clear purpose, careful planning, systematic data collection, and thoughtful analysis. Although it can be time-consuming, the rich, detailed insights a well-executed case study can provide make this study design an invaluable tool in research.

By following this guide and adopting its practical tips, you will be well on your way to crafting a compelling case study that contributes meaningful insights to your chosen field. Good luck with your research journey!

Header image by Kateryna Hliznitsova .

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Organizing Your Social Sciences Research Assignments

• Annotated Bibliography
• Analyzing a Scholarly Journal Article
• Group Presentations
• Dealing with Nervousness
• Using Visual Aids
• Grading Someone Else's Paper
• Types of Structured Group Activities
• Group Project Survival Skills
• Leading a Class Discussion
• Multiple Book Review Essay
• Reviewing Collected Works
• Writing a Case Analysis Paper
• Writing a Case Study
• About Informed Consent
• Writing Field Notes
• Writing a Policy Memo
• Writing a Reflective Paper
• Writing a Research Proposal
• Generative AI and Writing
• Acknowledgments

A case study research paper examines a person, place, event, condition, phenomenon, or other type of subject of analysis in order to extrapolate  key themes and results that help predict future trends, illuminate previously hidden issues that can be applied to practice, and/or provide a means for understanding an important research problem with greater clarity. A case study research paper usually examines a single subject of analysis, but case study papers can also be designed as a comparative investigation that shows relationships between two or more subjects. The methods used to study a case can rest within a quantitative, qualitative, or mixed-method investigative paradigm.

Case Studies. Writing@CSU. Colorado State University; Mills, Albert J. , Gabrielle Durepos, and Eiden Wiebe, editors. Encyclopedia of Case Study Research . Thousand Oaks, CA: SAGE Publications, 2010 ; “What is a Case Study?” In Swanborn, Peter G. Case Study Research: What, Why and How? London: SAGE, 2010.

How to Approach Writing a Case Study Research Paper

General information about how to choose a topic to investigate can be found under the " Choosing a Research Problem " tab in the Organizing Your Social Sciences Research Paper writing guide. Review this page because it may help you identify a subject of analysis that can be investigated using a case study design.

However, identifying a case to investigate involves more than choosing the research problem . A case study encompasses a problem contextualized around the application of in-depth analysis, interpretation, and discussion, often resulting in specific recommendations for action or for improving existing conditions. As Seawright and Gerring note, practical considerations such as time and access to information can influence case selection, but these issues should not be the sole factors used in describing the methodological justification for identifying a particular case to study. Given this, selecting a case includes considering the following:

• The case represents an unusual or atypical example of a research problem that requires more in-depth analysis? Cases often represent a topic that rests on the fringes of prior investigations because the case may provide new ways of understanding the research problem. For example, if the research problem is to identify strategies to improve policies that support girl's access to secondary education in predominantly Muslim nations, you could consider using Azerbaijan as a case study rather than selecting a more obvious nation in the Middle East. Doing so may reveal important new insights into recommending how governments in other predominantly Muslim nations can formulate policies that support improved access to education for girls.
• The case provides important insight or illuminate a previously hidden problem? In-depth analysis of a case can be based on the hypothesis that the case study will reveal trends or issues that have not been exposed in prior research or will reveal new and important implications for practice. For example, anecdotal evidence may suggest drug use among homeless veterans is related to their patterns of travel throughout the day. Assuming prior studies have not looked at individual travel choices as a way to study access to illicit drug use, a case study that observes a homeless veteran could reveal how issues of personal mobility choices facilitate regular access to illicit drugs. Note that it is important to conduct a thorough literature review to ensure that your assumption about the need to reveal new insights or previously hidden problems is valid and evidence-based.
• The case challenges and offers a counter-point to prevailing assumptions? Over time, research on any given topic can fall into a trap of developing assumptions based on outdated studies that are still applied to new or changing conditions or the idea that something should simply be accepted as "common sense," even though the issue has not been thoroughly tested in current practice. A case study analysis may offer an opportunity to gather evidence that challenges prevailing assumptions about a research problem and provide a new set of recommendations applied to practice that have not been tested previously. For example, perhaps there has been a long practice among scholars to apply a particular theory in explaining the relationship between two subjects of analysis. Your case could challenge this assumption by applying an innovative theoretical framework [perhaps borrowed from another discipline] to explore whether this approach offers new ways of understanding the research problem. Taking a contrarian stance is one of the most important ways that new knowledge and understanding develops from existing literature.
• The case provides an opportunity to pursue action leading to the resolution of a problem? Another way to think about choosing a case to study is to consider how the results from investigating a particular case may result in findings that reveal ways in which to resolve an existing or emerging problem. For example, studying the case of an unforeseen incident, such as a fatal accident at a railroad crossing, can reveal hidden issues that could be applied to preventative measures that contribute to reducing the chance of accidents in the future. In this example, a case study investigating the accident could lead to a better understanding of where to strategically locate additional signals at other railroad crossings so as to better warn drivers of an approaching train, particularly when visibility is hindered by heavy rain, fog, or at night.
• The case offers a new direction in future research? A case study can be used as a tool for an exploratory investigation that highlights the need for further research about the problem. A case can be used when there are few studies that help predict an outcome or that establish a clear understanding about how best to proceed in addressing a problem. For example, after conducting a thorough literature review [very important!], you discover that little research exists showing the ways in which women contribute to promoting water conservation in rural communities of east central Africa. A case study of how women contribute to saving water in a rural village of Uganda can lay the foundation for understanding the need for more thorough research that documents how women in their roles as cooks and family caregivers think about water as a valuable resource within their community. This example of a case study could also point to the need for scholars to build new theoretical frameworks around the topic [e.g., applying feminist theories of work and family to the issue of water conservation].

Eisenhardt, Kathleen M. “Building Theories from Case Study Research.” Academy of Management Review 14 (October 1989): 532-550; Emmel, Nick. Sampling and Choosing Cases in Qualitative Research: A Realist Approach . Thousand Oaks, CA: SAGE Publications, 2013; Gerring, John. “What Is a Case Study and What Is It Good for?” American Political Science Review 98 (May 2004): 341-354; Mills, Albert J. , Gabrielle Durepos, and Eiden Wiebe, editors. Encyclopedia of Case Study Research . Thousand Oaks, CA: SAGE Publications, 2010; Seawright, Jason and John Gerring. "Case Selection Techniques in Case Study Research." Political Research Quarterly 61 (June 2008): 294-308.

Structure and Writing Style

The purpose of a paper in the social sciences designed around a case study is to thoroughly investigate a subject of analysis in order to reveal a new understanding about the research problem and, in so doing, contributing new knowledge to what is already known from previous studies. In applied social sciences disciplines [e.g., education, social work, public administration, etc.], case studies may also be used to reveal best practices, highlight key programs, or investigate interesting aspects of professional work.

In general, the structure of a case study research paper is not all that different from a standard college-level research paper. However, there are subtle differences you should be aware of. Here are the key elements to organizing and writing a case study research paper.

I.  Introduction

As with any research paper, your introduction should serve as a roadmap for your readers to ascertain the scope and purpose of your study . The introduction to a case study research paper, however, should not only describe the research problem and its significance, but you should also succinctly describe why the case is being used and how it relates to addressing the problem. The two elements should be linked. With this in mind, a good introduction answers these four questions:

• What is being studied? Describe the research problem and describe the subject of analysis [the case] you have chosen to address the problem. Explain how they are linked and what elements of the case will help to expand knowledge and understanding about the problem.
• Why is this topic important to investigate? Describe the significance of the research problem and state why a case study design and the subject of analysis that the paper is designed around is appropriate in addressing the problem.
• What did we know about this topic before I did this study? Provide background that helps lead the reader into the more in-depth literature review to follow. If applicable, summarize prior case study research applied to the research problem and why it fails to adequately address the problem. Describe why your case will be useful. If no prior case studies have been used to address the research problem, explain why you have selected this subject of analysis.
• How will this study advance new knowledge or new ways of understanding? Explain why your case study will be suitable in helping to expand knowledge and understanding about the research problem.

Each of these questions should be addressed in no more than a few paragraphs. Exceptions to this can be when you are addressing a complex research problem or subject of analysis that requires more in-depth background information.

II.  Literature Review

The literature review for a case study research paper is generally structured the same as it is for any college-level research paper. The difference, however, is that the literature review is focused on providing background information and  enabling historical interpretation of the subject of analysis in relation to the research problem the case is intended to address . This includes synthesizing studies that help to:

• Place relevant works in the context of their contribution to understanding the case study being investigated . This would involve summarizing studies that have used a similar subject of analysis to investigate the research problem. If there is literature using the same or a very similar case to study, you need to explain why duplicating past research is important [e.g., conditions have changed; prior studies were conducted long ago, etc.].
• Describe the relationship each work has to the others under consideration that informs the reader why this case is applicable . Your literature review should include a description of any works that support using the case to investigate the research problem and the underlying research questions.
• Identify new ways to interpret prior research using the case study . If applicable, review any research that has examined the research problem using a different research design. Explain how your use of a case study design may reveal new knowledge or a new perspective or that can redirect research in an important new direction.
• Resolve conflicts amongst seemingly contradictory previous studies . This refers to synthesizing any literature that points to unresolved issues of concern about the research problem and describing how the subject of analysis that forms the case study can help resolve these existing contradictions.
• Point the way in fulfilling a need for additional research . Your review should examine any literature that lays a foundation for understanding why your case study design and the subject of analysis around which you have designed your study may reveal a new way of approaching the research problem or offer a perspective that points to the need for additional research.
• Expose any gaps that exist in the literature that the case study could help to fill . Summarize any literature that not only shows how your subject of analysis contributes to understanding the research problem, but how your case contributes to a new way of understanding the problem that prior research has failed to do.
• Locate your own research within the context of existing literature [very important!] . Collectively, your literature review should always place your case study within the larger domain of prior research about the problem. The overarching purpose of reviewing pertinent literature in a case study paper is to demonstrate that you have thoroughly identified and synthesized prior studies in relation to explaining the relevance of the case in addressing the research problem.

III.  Method

In this section, you explain why you selected a particular case [i.e., subject of analysis] and the strategy you used to identify and ultimately decide that your case was appropriate in addressing the research problem. The way you describe the methods used varies depending on the type of subject of analysis that constitutes your case study.

If your subject of analysis is an incident or event . In the social and behavioral sciences, the event or incident that represents the case to be studied is usually bounded by time and place, with a clear beginning and end and with an identifiable location or position relative to its surroundings. The subject of analysis can be a rare or critical event or it can focus on a typical or regular event. The purpose of studying a rare event is to illuminate new ways of thinking about the broader research problem or to test a hypothesis. Critical incident case studies must describe the method by which you identified the event and explain the process by which you determined the validity of this case to inform broader perspectives about the research problem or to reveal new findings. However, the event does not have to be a rare or uniquely significant to support new thinking about the research problem or to challenge an existing hypothesis. For example, Walo, Bull, and Breen conducted a case study to identify and evaluate the direct and indirect economic benefits and costs of a local sports event in the City of Lismore, New South Wales, Australia. The purpose of their study was to provide new insights from measuring the impact of a typical local sports event that prior studies could not measure well because they focused on large "mega-events." Whether the event is rare or not, the methods section should include an explanation of the following characteristics of the event: a) when did it take place; b) what were the underlying circumstances leading to the event; and, c) what were the consequences of the event in relation to the research problem.

If your subject of analysis is a person. Explain why you selected this particular individual to be studied and describe what experiences they have had that provide an opportunity to advance new understandings about the research problem. Mention any background about this person which might help the reader understand the significance of their experiences that make them worthy of study. This includes describing the relationships this person has had with other people, institutions, and/or events that support using them as the subject for a case study research paper. It is particularly important to differentiate the person as the subject of analysis from others and to succinctly explain how the person relates to examining the research problem [e.g., why is one politician in a particular local election used to show an increase in voter turnout from any other candidate running in the election]. Note that these issues apply to a specific group of people used as a case study unit of analysis [e.g., a classroom of students].

If your subject of analysis is a place. In general, a case study that investigates a place suggests a subject of analysis that is unique or special in some way and that this uniqueness can be used to build new understanding or knowledge about the research problem. A case study of a place must not only describe its various attributes relevant to the research problem [e.g., physical, social, historical, cultural, economic, political], but you must state the method by which you determined that this place will illuminate new understandings about the research problem. It is also important to articulate why a particular place as the case for study is being used if similar places also exist [i.e., if you are studying patterns of homeless encampments of veterans in open spaces, explain why you are studying Echo Park in Los Angeles rather than Griffith Park?]. If applicable, describe what type of human activity involving this place makes it a good choice to study [e.g., prior research suggests Echo Park has more homeless veterans].

If your subject of analysis is a phenomenon. A phenomenon refers to a fact, occurrence, or circumstance that can be studied or observed but with the cause or explanation to be in question. In this sense, a phenomenon that forms your subject of analysis can encompass anything that can be observed or presumed to exist but is not fully understood. In the social and behavioral sciences, the case usually focuses on human interaction within a complex physical, social, economic, cultural, or political system. For example, the phenomenon could be the observation that many vehicles used by ISIS fighters are small trucks with English language advertisements on them. The research problem could be that ISIS fighters are difficult to combat because they are highly mobile. The research questions could be how and by what means are these vehicles used by ISIS being supplied to the militants and how might supply lines to these vehicles be cut off? How might knowing the suppliers of these trucks reveal larger networks of collaborators and financial support? A case study of a phenomenon most often encompasses an in-depth analysis of a cause and effect that is grounded in an interactive relationship between people and their environment in some way.

NOTE:   The choice of the case or set of cases to study cannot appear random. Evidence that supports the method by which you identified and chose your subject of analysis should clearly support investigation of the research problem and linked to key findings from your literature review. Be sure to cite any studies that helped you determine that the case you chose was appropriate for examining the problem.

IV.  Discussion

The main elements of your discussion section are generally the same as any research paper, but centered around interpreting and drawing conclusions about the key findings from your analysis of the case study. Note that a general social sciences research paper may contain a separate section to report findings. However, in a paper designed around a case study, it is common to combine a description of the results with the discussion about their implications. The objectives of your discussion section should include the following:

Reiterate the Research Problem/State the Major Findings Briefly reiterate the research problem you are investigating and explain why the subject of analysis around which you designed the case study were used. You should then describe the findings revealed from your study of the case using direct, declarative, and succinct proclamation of the study results. Highlight any findings that were unexpected or especially profound.

Explain the Meaning of the Findings and Why They are Important Systematically explain the meaning of your case study findings and why you believe they are important. Begin this part of the section by repeating what you consider to be your most important or surprising finding first, then systematically review each finding. Be sure to thoroughly extrapolate what your analysis of the case can tell the reader about situations or conditions beyond the actual case that was studied while, at the same time, being careful not to misconstrue or conflate a finding that undermines the external validity of your conclusions.

Relate the Findings to Similar Studies No study in the social sciences is so novel or possesses such a restricted focus that it has absolutely no relation to previously published research. The discussion section should relate your case study results to those found in other studies, particularly if questions raised from prior studies served as the motivation for choosing your subject of analysis. This is important because comparing and contrasting the findings of other studies helps support the overall importance of your results and it highlights how and in what ways your case study design and the subject of analysis differs from prior research about the topic.

Consider Alternative Explanations of the Findings Remember that the purpose of social science research is to discover and not to prove. When writing the discussion section, you should carefully consider all possible explanations revealed by the case study results, rather than just those that fit your hypothesis or prior assumptions and biases. Be alert to what the in-depth analysis of the case may reveal about the research problem, including offering a contrarian perspective to what scholars have stated in prior research if that is how the findings can be interpreted from your case.

Acknowledge the Study's Limitations You can state the study's limitations in the conclusion section of your paper but describing the limitations of your subject of analysis in the discussion section provides an opportunity to identify the limitations and explain why they are not significant. This part of the discussion section should also note any unanswered questions or issues your case study could not address. More detailed information about how to document any limitations to your research can be found here .

Suggest Areas for Further Research Although your case study may offer important insights about the research problem, there are likely additional questions related to the problem that remain unanswered or findings that unexpectedly revealed themselves as a result of your in-depth analysis of the case. Be sure that the recommendations for further research are linked to the research problem and that you explain why your recommendations are valid in other contexts and based on the original assumptions of your study.

V.  Conclusion

As with any research paper, you should summarize your conclusion in clear, simple language; emphasize how the findings from your case study differs from or supports prior research and why. Do not simply reiterate the discussion section. Provide a synthesis of key findings presented in the paper to show how these converge to address the research problem. If you haven't already done so in the discussion section, be sure to document the limitations of your case study and any need for further research.

The function of your paper's conclusion is to: 1) reiterate the main argument supported by the findings from your case study; 2) state clearly the context, background, and necessity of pursuing the research problem using a case study design in relation to an issue, controversy, or a gap found from reviewing the literature; and, 3) provide a place to persuasively and succinctly restate the significance of your research problem, given that the reader has now been presented with in-depth information about the topic.

Consider the following points to help ensure your conclusion is appropriate:

• If the argument or purpose of your paper is complex, you may need to summarize these points for your reader.
• If prior to your conclusion, you have not yet explained the significance of your findings or if you are proceeding inductively, use the conclusion of your paper to describe your main points and explain their significance.
• Move from a detailed to a general level of consideration of the case study's findings that returns the topic to the context provided by the introduction or within a new context that emerges from your case study findings.

Note that, depending on the discipline you are writing in or the preferences of your professor, the concluding paragraph may contain your final reflections on the evidence presented as it applies to practice or on the essay's central research problem. However, the nature of being introspective about the subject of analysis you have investigated will depend on whether you are explicitly asked to express your observations in this way.

Problems to Avoid

Overgeneralization One of the goals of a case study is to lay a foundation for understanding broader trends and issues applied to similar circumstances. However, be careful when drawing conclusions from your case study. They must be evidence-based and grounded in the results of the study; otherwise, it is merely speculation. Looking at a prior example, it would be incorrect to state that a factor in improving girls access to education in Azerbaijan and the policy implications this may have for improving access in other Muslim nations is due to girls access to social media if there is no documentary evidence from your case study to indicate this. There may be anecdotal evidence that retention rates were better for girls who were engaged with social media, but this observation would only point to the need for further research and would not be a definitive finding if this was not a part of your original research agenda.

Failure to Document Limitations No case is going to reveal all that needs to be understood about a research problem. Therefore, just as you have to clearly state the limitations of a general research study , you must describe the specific limitations inherent in the subject of analysis. For example, the case of studying how women conceptualize the need for water conservation in a village in Uganda could have limited application in other cultural contexts or in areas where fresh water from rivers or lakes is plentiful and, therefore, conservation is understood more in terms of managing access rather than preserving access to a scarce resource.

Failure to Extrapolate All Possible Implications Just as you don't want to over-generalize from your case study findings, you also have to be thorough in the consideration of all possible outcomes or recommendations derived from your findings. If you do not, your reader may question the validity of your analysis, particularly if you failed to document an obvious outcome from your case study research. For example, in the case of studying the accident at the railroad crossing to evaluate where and what types of warning signals should be located, you failed to take into consideration speed limit signage as well as warning signals. When designing your case study, be sure you have thoroughly addressed all aspects of the problem and do not leave gaps in your analysis that leave the reader questioning the results.

Case Studies. Writing@CSU. Colorado State University; Gerring, John. Case Study Research: Principles and Practices . New York: Cambridge University Press, 2007; Merriam, Sharan B. Qualitative Research and Case Study Applications in Education . Rev. ed. San Francisco, CA: Jossey-Bass, 1998; Miller, Lisa L. “The Use of Case Studies in Law and Social Science Research.” Annual Review of Law and Social Science 14 (2018): TBD; Mills, Albert J., Gabrielle Durepos, and Eiden Wiebe, editors. Encyclopedia of Case Study Research . Thousand Oaks, CA: SAGE Publications, 2010; Putney, LeAnn Grogan. "Case Study." In Encyclopedia of Research Design , Neil J. Salkind, editor. (Thousand Oaks, CA: SAGE Publications, 2010), pp. 116-120; Simons, Helen. Case Study Research in Practice . London: SAGE Publications, 2009;  Kratochwill,  Thomas R. and Joel R. Levin, editors. Single-Case Research Design and Analysis: New Development for Psychology and Education .  Hilldsale, NJ: Lawrence Erlbaum Associates, 1992; Swanborn, Peter G. Case Study Research: What, Why and How? London : SAGE, 2010; Yin, Robert K. Case Study Research: Design and Methods . 6th edition. Los Angeles, CA, SAGE Publications, 2014; Walo, Maree, Adrian Bull, and Helen Breen. “Achieving Economic Benefits at Local Events: A Case Study of a Local Sports Event.” Festival Management and Event Tourism 4 (1996): 95-106.

Writing Tip

At Least Five Misconceptions about Case Study Research

Social science case studies are often perceived as limited in their ability to create new knowledge because they are not randomly selected and findings cannot be generalized to larger populations. Flyvbjerg examines five misunderstandings about case study research and systematically "corrects" each one. To quote, these are:

Misunderstanding 1 :  General, theoretical [context-independent] knowledge is more valuable than concrete, practical [context-dependent] knowledge. Misunderstanding 2 :  One cannot generalize on the basis of an individual case; therefore, the case study cannot contribute to scientific development. Misunderstanding 3 :  The case study is most useful for generating hypotheses; that is, in the first stage of a total research process, whereas other methods are more suitable for hypotheses testing and theory building. Misunderstanding 4 :  The case study contains a bias toward verification, that is, a tendency to confirm the researcher’s preconceived notions. Misunderstanding 5 :  It is often difficult to summarize and develop general propositions and theories on the basis of specific case studies [p. 221].

While writing your paper, think introspectively about how you addressed these misconceptions because to do so can help you strengthen the validity and reliability of your research by clarifying issues of case selection, the testing and challenging of existing assumptions, the interpretation of key findings, and the summation of case outcomes. Think of a case study research paper as a complete, in-depth narrative about the specific properties and key characteristics of your subject of analysis applied to the research problem.

Flyvbjerg, Bent. “Five Misunderstandings About Case-Study Research.” Qualitative Inquiry 12 (April 2006): 219-245.

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• Published: 27 June 2011

The case study approach

• Sarah Crowe 1 ,
• Kathrin Cresswell 2 ,
• Ann Robertson 2 ,
• Guro Huby 3 ,
• Anthony Avery 1 &
• Aziz Sheikh 2  

BMC Medical Research Methodology volume  11 , Article number:  100 ( 2011 ) Cite this article

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The case study approach allows in-depth, multi-faceted explorations of complex issues in their real-life settings. The value of the case study approach is well recognised in the fields of business, law and policy, but somewhat less so in health services research. Based on our experiences of conducting several health-related case studies, we reflect on the different types of case study design, the specific research questions this approach can help answer, the data sources that tend to be used, and the particular advantages and disadvantages of employing this methodological approach. The paper concludes with key pointers to aid those designing and appraising proposals for conducting case study research, and a checklist to help readers assess the quality of case study reports.

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Introduction

The case study approach is particularly useful to employ when there is a need to obtain an in-depth appreciation of an issue, event or phenomenon of interest, in its natural real-life context. Our aim in writing this piece is to provide insights into when to consider employing this approach and an overview of key methodological considerations in relation to the design, planning, analysis, interpretation and reporting of case studies.

The illustrative 'grand round', 'case report' and 'case series' have a long tradition in clinical practice and research. Presenting detailed critiques, typically of one or more patients, aims to provide insights into aspects of the clinical case and, in doing so, illustrate broader lessons that may be learnt. In research, the conceptually-related case study approach can be used, for example, to describe in detail a patient's episode of care, explore professional attitudes to and experiences of a new policy initiative or service development or more generally to 'investigate contemporary phenomena within its real-life context' [ 1 ]. Based on our experiences of conducting a range of case studies, we reflect on when to consider using this approach, discuss the key steps involved and illustrate, with examples, some of the practical challenges of attaining an in-depth understanding of a 'case' as an integrated whole. In keeping with previously published work, we acknowledge the importance of theory to underpin the design, selection, conduct and interpretation of case studies[ 2 ]. In so doing, we make passing reference to the different epistemological approaches used in case study research by key theoreticians and methodologists in this field of enquiry.

This paper is structured around the following main questions: What is a case study? What are case studies used for? How are case studies conducted? What are the potential pitfalls and how can these be avoided? We draw in particular on four of our own recently published examples of case studies (see Tables 1 , 2 , 3 and 4 ) and those of others to illustrate our discussion[ 3 – 7 ].

What is a case study?

A case study is a research approach that is used to generate an in-depth, multi-faceted understanding of a complex issue in its real-life context. It is an established research design that is used extensively in a wide variety of disciplines, particularly in the social sciences. A case study can be defined in a variety of ways (Table 5 ), the central tenet being the need to explore an event or phenomenon in depth and in its natural context. It is for this reason sometimes referred to as a "naturalistic" design; this is in contrast to an "experimental" design (such as a randomised controlled trial) in which the investigator seeks to exert control over and manipulate the variable(s) of interest.

Stake's work has been particularly influential in defining the case study approach to scientific enquiry. He has helpfully characterised three main types of case study: intrinsic , instrumental and collective [ 8 ]. An intrinsic case study is typically undertaken to learn about a unique phenomenon. The researcher should define the uniqueness of the phenomenon, which distinguishes it from all others. In contrast, the instrumental case study uses a particular case (some of which may be better than others) to gain a broader appreciation of an issue or phenomenon. The collective case study involves studying multiple cases simultaneously or sequentially in an attempt to generate a still broader appreciation of a particular issue.

These are however not necessarily mutually exclusive categories. In the first of our examples (Table 1 ), we undertook an intrinsic case study to investigate the issue of recruitment of minority ethnic people into the specific context of asthma research studies, but it developed into a instrumental case study through seeking to understand the issue of recruitment of these marginalised populations more generally, generating a number of the findings that are potentially transferable to other disease contexts[ 3 ]. In contrast, the other three examples (see Tables 2 , 3 and 4 ) employed collective case study designs to study the introduction of workforce reconfiguration in primary care, the implementation of electronic health records into hospitals, and to understand the ways in which healthcare students learn about patient safety considerations[ 4 – 6 ]. Although our study focusing on the introduction of General Practitioners with Specialist Interests (Table 2 ) was explicitly collective in design (four contrasting primary care organisations were studied), is was also instrumental in that this particular professional group was studied as an exemplar of the more general phenomenon of workforce redesign[ 4 ].

What are case studies used for?

According to Yin, case studies can be used to explain, describe or explore events or phenomena in the everyday contexts in which they occur[ 1 ]. These can, for example, help to understand and explain causal links and pathways resulting from a new policy initiative or service development (see Tables 2 and 3 , for example)[ 1 ]. In contrast to experimental designs, which seek to test a specific hypothesis through deliberately manipulating the environment (like, for example, in a randomised controlled trial giving a new drug to randomly selected individuals and then comparing outcomes with controls),[ 9 ] the case study approach lends itself well to capturing information on more explanatory ' how ', 'what' and ' why ' questions, such as ' how is the intervention being implemented and received on the ground?'. The case study approach can offer additional insights into what gaps exist in its delivery or why one implementation strategy might be chosen over another. This in turn can help develop or refine theory, as shown in our study of the teaching of patient safety in undergraduate curricula (Table 4 )[ 6 , 10 ]. Key questions to consider when selecting the most appropriate study design are whether it is desirable or indeed possible to undertake a formal experimental investigation in which individuals and/or organisations are allocated to an intervention or control arm? Or whether the wish is to obtain a more naturalistic understanding of an issue? The former is ideally studied using a controlled experimental design, whereas the latter is more appropriately studied using a case study design.

Case studies may be approached in different ways depending on the epistemological standpoint of the researcher, that is, whether they take a critical (questioning one's own and others' assumptions), interpretivist (trying to understand individual and shared social meanings) or positivist approach (orientating towards the criteria of natural sciences, such as focusing on generalisability considerations) (Table 6 ). Whilst such a schema can be conceptually helpful, it may be appropriate to draw on more than one approach in any case study, particularly in the context of conducting health services research. Doolin has, for example, noted that in the context of undertaking interpretative case studies, researchers can usefully draw on a critical, reflective perspective which seeks to take into account the wider social and political environment that has shaped the case[ 11 ].

How are case studies conducted?

Here, we focus on the main stages of research activity when planning and undertaking a case study; the crucial stages are: defining the case; selecting the case(s); collecting and analysing the data; interpreting data; and reporting the findings.

Defining the case

Carefully formulated research question(s), informed by the existing literature and a prior appreciation of the theoretical issues and setting(s), are all important in appropriately and succinctly defining the case[ 8 , 12 ]. Crucially, each case should have a pre-defined boundary which clarifies the nature and time period covered by the case study (i.e. its scope, beginning and end), the relevant social group, organisation or geographical area of interest to the investigator, the types of evidence to be collected, and the priorities for data collection and analysis (see Table 7 )[ 1 ]. A theory driven approach to defining the case may help generate knowledge that is potentially transferable to a range of clinical contexts and behaviours; using theory is also likely to result in a more informed appreciation of, for example, how and why interventions have succeeded or failed[ 13 ].

For example, in our evaluation of the introduction of electronic health records in English hospitals (Table 3 ), we defined our cases as the NHS Trusts that were receiving the new technology[ 5 ]. Our focus was on how the technology was being implemented. However, if the primary research interest had been on the social and organisational dimensions of implementation, we might have defined our case differently as a grouping of healthcare professionals (e.g. doctors and/or nurses). The precise beginning and end of the case may however prove difficult to define. Pursuing this same example, when does the process of implementation and adoption of an electronic health record system really begin or end? Such judgements will inevitably be influenced by a range of factors, including the research question, theory of interest, the scope and richness of the gathered data and the resources available to the research team.

Selecting the case(s)

The decision on how to select the case(s) to study is a very important one that merits some reflection. In an intrinsic case study, the case is selected on its own merits[ 8 ]. The case is selected not because it is representative of other cases, but because of its uniqueness, which is of genuine interest to the researchers. This was, for example, the case in our study of the recruitment of minority ethnic participants into asthma research (Table 1 ) as our earlier work had demonstrated the marginalisation of minority ethnic people with asthma, despite evidence of disproportionate asthma morbidity[ 14 , 15 ]. In another example of an intrinsic case study, Hellstrom et al.[ 16 ] studied an elderly married couple living with dementia to explore how dementia had impacted on their understanding of home, their everyday life and their relationships.

For an instrumental case study, selecting a "typical" case can work well[ 8 ]. In contrast to the intrinsic case study, the particular case which is chosen is of less importance than selecting a case that allows the researcher to investigate an issue or phenomenon. For example, in order to gain an understanding of doctors' responses to health policy initiatives, Som undertook an instrumental case study interviewing clinicians who had a range of responsibilities for clinical governance in one NHS acute hospital trust[ 17 ]. Sampling a "deviant" or "atypical" case may however prove even more informative, potentially enabling the researcher to identify causal processes, generate hypotheses and develop theory.

In collective or multiple case studies, a number of cases are carefully selected. This offers the advantage of allowing comparisons to be made across several cases and/or replication. Choosing a "typical" case may enable the findings to be generalised to theory (i.e. analytical generalisation) or to test theory by replicating the findings in a second or even a third case (i.e. replication logic)[ 1 ]. Yin suggests two or three literal replications (i.e. predicting similar results) if the theory is straightforward and five or more if the theory is more subtle. However, critics might argue that selecting 'cases' in this way is insufficiently reflexive and ill-suited to the complexities of contemporary healthcare organisations.

The selected case study site(s) should allow the research team access to the group of individuals, the organisation, the processes or whatever else constitutes the chosen unit of analysis for the study. Access is therefore a central consideration; the researcher needs to come to know the case study site(s) well and to work cooperatively with them. Selected cases need to be not only interesting but also hospitable to the inquiry [ 8 ] if they are to be informative and answer the research question(s). Case study sites may also be pre-selected for the researcher, with decisions being influenced by key stakeholders. For example, our selection of case study sites in the evaluation of the implementation and adoption of electronic health record systems (see Table 3 ) was heavily influenced by NHS Connecting for Health, the government agency that was responsible for overseeing the National Programme for Information Technology (NPfIT)[ 5 ]. This prominent stakeholder had already selected the NHS sites (through a competitive bidding process) to be early adopters of the electronic health record systems and had negotiated contracts that detailed the deployment timelines.

It is also important to consider in advance the likely burden and risks associated with participation for those who (or the site(s) which) comprise the case study. Of particular importance is the obligation for the researcher to think through the ethical implications of the study (e.g. the risk of inadvertently breaching anonymity or confidentiality) and to ensure that potential participants/participating sites are provided with sufficient information to make an informed choice about joining the study. The outcome of providing this information might be that the emotive burden associated with participation, or the organisational disruption associated with supporting the fieldwork, is considered so high that the individuals or sites decide against participation.

In our example of evaluating implementations of electronic health record systems, given the restricted number of early adopter sites available to us, we sought purposively to select a diverse range of implementation cases among those that were available[ 5 ]. We chose a mixture of teaching, non-teaching and Foundation Trust hospitals, and examples of each of the three electronic health record systems procured centrally by the NPfIT. At one recruited site, it quickly became apparent that access was problematic because of competing demands on that organisation. Recognising the importance of full access and co-operative working for generating rich data, the research team decided not to pursue work at that site and instead to focus on other recruited sites.

Collecting the data

In order to develop a thorough understanding of the case, the case study approach usually involves the collection of multiple sources of evidence, using a range of quantitative (e.g. questionnaires, audits and analysis of routinely collected healthcare data) and more commonly qualitative techniques (e.g. interviews, focus groups and observations). The use of multiple sources of data (data triangulation) has been advocated as a way of increasing the internal validity of a study (i.e. the extent to which the method is appropriate to answer the research question)[ 8 , 18 – 21 ]. An underlying assumption is that data collected in different ways should lead to similar conclusions, and approaching the same issue from different angles can help develop a holistic picture of the phenomenon (Table 2 )[ 4 ].

Brazier and colleagues used a mixed-methods case study approach to investigate the impact of a cancer care programme[ 22 ]. Here, quantitative measures were collected with questionnaires before, and five months after, the start of the intervention which did not yield any statistically significant results. Qualitative interviews with patients however helped provide an insight into potentially beneficial process-related aspects of the programme, such as greater, perceived patient involvement in care. The authors reported how this case study approach provided a number of contextual factors likely to influence the effectiveness of the intervention and which were not likely to have been obtained from quantitative methods alone.

In collective or multiple case studies, data collection needs to be flexible enough to allow a detailed description of each individual case to be developed (e.g. the nature of different cancer care programmes), before considering the emerging similarities and differences in cross-case comparisons (e.g. to explore why one programme is more effective than another). It is important that data sources from different cases are, where possible, broadly comparable for this purpose even though they may vary in nature and depth.

Analysing, interpreting and reporting case studies

Making sense and offering a coherent interpretation of the typically disparate sources of data (whether qualitative alone or together with quantitative) is far from straightforward. Repeated reviewing and sorting of the voluminous and detail-rich data are integral to the process of analysis. In collective case studies, it is helpful to analyse data relating to the individual component cases first, before making comparisons across cases. Attention needs to be paid to variations within each case and, where relevant, the relationship between different causes, effects and outcomes[ 23 ]. Data will need to be organised and coded to allow the key issues, both derived from the literature and emerging from the dataset, to be easily retrieved at a later stage. An initial coding frame can help capture these issues and can be applied systematically to the whole dataset with the aid of a qualitative data analysis software package.

The Framework approach is a practical approach, comprising of five stages (familiarisation; identifying a thematic framework; indexing; charting; mapping and interpretation) , to managing and analysing large datasets particularly if time is limited, as was the case in our study of recruitment of South Asians into asthma research (Table 1 )[ 3 , 24 ]. Theoretical frameworks may also play an important role in integrating different sources of data and examining emerging themes. For example, we drew on a socio-technical framework to help explain the connections between different elements - technology; people; and the organisational settings within which they worked - in our study of the introduction of electronic health record systems (Table 3 )[ 5 ]. Our study of patient safety in undergraduate curricula drew on an evaluation-based approach to design and analysis, which emphasised the importance of the academic, organisational and practice contexts through which students learn (Table 4 )[ 6 ].

Case study findings can have implications both for theory development and theory testing. They may establish, strengthen or weaken historical explanations of a case and, in certain circumstances, allow theoretical (as opposed to statistical) generalisation beyond the particular cases studied[ 12 ]. These theoretical lenses should not, however, constitute a strait-jacket and the cases should not be "forced to fit" the particular theoretical framework that is being employed.

When reporting findings, it is important to provide the reader with enough contextual information to understand the processes that were followed and how the conclusions were reached. In a collective case study, researchers may choose to present the findings from individual cases separately before amalgamating across cases. Care must be taken to ensure the anonymity of both case sites and individual participants (if agreed in advance) by allocating appropriate codes or withholding descriptors. In the example given in Table 3 , we decided against providing detailed information on the NHS sites and individual participants in order to avoid the risk of inadvertent disclosure of identities[ 5 , 25 ].

What are the potential pitfalls and how can these be avoided?

The case study approach is, as with all research, not without its limitations. When investigating the formal and informal ways undergraduate students learn about patient safety (Table 4 ), for example, we rapidly accumulated a large quantity of data. The volume of data, together with the time restrictions in place, impacted on the depth of analysis that was possible within the available resources. This highlights a more general point of the importance of avoiding the temptation to collect as much data as possible; adequate time also needs to be set aside for data analysis and interpretation of what are often highly complex datasets.

Case study research has sometimes been criticised for lacking scientific rigour and providing little basis for generalisation (i.e. producing findings that may be transferable to other settings)[ 1 ]. There are several ways to address these concerns, including: the use of theoretical sampling (i.e. drawing on a particular conceptual framework); respondent validation (i.e. participants checking emerging findings and the researcher's interpretation, and providing an opinion as to whether they feel these are accurate); and transparency throughout the research process (see Table 8 )[ 8 , 18 – 21 , 23 , 26 ]. Transparency can be achieved by describing in detail the steps involved in case selection, data collection, the reasons for the particular methods chosen, and the researcher's background and level of involvement (i.e. being explicit about how the researcher has influenced data collection and interpretation). Seeking potential, alternative explanations, and being explicit about how interpretations and conclusions were reached, help readers to judge the trustworthiness of the case study report. Stake provides a critique checklist for a case study report (Table 9 )[ 8 ].

Conclusions

The case study approach allows, amongst other things, critical events, interventions, policy developments and programme-based service reforms to be studied in detail in a real-life context. It should therefore be considered when an experimental design is either inappropriate to answer the research questions posed or impossible to undertake. Considering the frequency with which implementations of innovations are now taking place in healthcare settings and how well the case study approach lends itself to in-depth, complex health service research, we believe this approach should be more widely considered by researchers. Though inherently challenging, the research case study can, if carefully conceptualised and thoughtfully undertaken and reported, yield powerful insights into many important aspects of health and healthcare delivery.

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Acknowledgements

We are grateful to the participants and colleagues who contributed to the individual case studies that we have drawn on. This work received no direct funding, but it has been informed by projects funded by Asthma UK, the NHS Service Delivery Organisation, NHS Connecting for Health Evaluation Programme, and Patient Safety Research Portfolio. We would also like to thank the expert reviewers for their insightful and constructive feedback. Our thanks are also due to Dr. Allison Worth who commented on an earlier draft of this manuscript.

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Sarah Crowe & Anthony Avery

Centre for Population Health Sciences, The University of Edinburgh, Edinburgh, UK

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AS conceived this article. SC, KC and AR wrote this paper with GH, AA and AS all commenting on various drafts. SC and AS are guarantors.

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Do Your Students Know How to Analyze a Case—Really?

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• Case Teaching
• Student Engagement

J ust as actors, athletes, and musicians spend thousands of hours practicing their craft, business students benefit from practicing their critical-thinking and decision-making skills. Students, however, often have limited exposure to real-world problem-solving scenarios; they need more opportunities to practice tackling tough business problems and deciding on—and executing—the best solutions.

To ensure students have ample opportunity to develop these critical-thinking and decision-making skills, we believe business faculty should shift from teaching mostly principles and ideas to mostly applications and practices. And in doing so, they should emphasize the case method, which simulates real-world management challenges and opportunities for students.

To help educators facilitate this shift and help students get the most out of case-based learning, we have developed a framework for analyzing cases. We call it PACADI (Problem, Alternatives, Criteria, Analysis, Decision, Implementation); it can improve learning outcomes by helping students better solve and analyze business problems, make decisions, and develop and implement strategy. Here, we’ll explain why we developed this framework, how it works, and what makes it an effective learning tool.

The Case for Cases: Helping Students Think Critically

Business students must develop critical-thinking and analytical skills, which are essential to their ability to make good decisions in functional areas such as marketing, finance, operations, and information technology, as well as to understand the relationships among these functions. For example, the decisions a marketing manager must make include strategic planning (segments, products, and channels); execution (digital messaging, media, branding, budgets, and pricing); and operations (integrated communications and technologies), as well as how to implement decisions across functional areas.

Faculty can use many types of cases to help students develop these skills. These include the prototypical “paper cases”; live cases , which feature guest lecturers such as entrepreneurs or corporate leaders and on-site visits; and multimedia cases , which immerse students into real situations. Most cases feature an explicit or implicit decision that a protagonist—whether it is an individual, a group, or an organization—must make.

For students new to learning by the case method—and even for those with case experience—some common issues can emerge; these issues can sometimes be a barrier for educators looking to ensure the best possible outcomes in their case classrooms. Unsure of how to dig into case analysis on their own, students may turn to the internet or rely on former students for “answers” to assigned cases. Or, when assigned to provide answers to assignment questions in teams, students might take a divide-and-conquer approach but not take the time to regroup and provide answers that are consistent with one other.

To help address these issues, which we commonly experienced in our classes, we wanted to provide our students with a more structured approach for how they analyze cases—and to really think about making decisions from the protagonists’ point of view. We developed the PACADI framework to address this need.

PACADI: A Six-Step Decision-Making Approach

The PACADI framework is a six-step decision-making approach that can be used in lieu of traditional end-of-case questions. It offers a structured, integrated, and iterative process that requires students to analyze case information, apply business concepts to derive valuable insights, and develop recommendations based on these insights.

Prior to beginning a PACADI assessment, which we’ll outline here, students should first prepare a two-paragraph summary—a situation analysis—that highlights the key case facts. Then, we task students with providing a five-page PACADI case analysis (excluding appendices) based on the following six steps.

Step 1: Problem definition. What is the major challenge, problem, opportunity, or decision that has to be made? If there is more than one problem, choose the most important one. Often when solving the key problem, other issues will surface and be addressed. The problem statement may be framed as a question; for example, How can brand X improve market share among millennials in Canada? Usually the problem statement has to be re-written several times during the analysis of a case as students peel back the layers of symptoms or causation.

Step 2: Alternatives. Identify in detail the strategic alternatives to address the problem; three to five options generally work best. Alternatives should be mutually exclusive, realistic, creative, and feasible given the constraints of the situation. Doing nothing or delaying the decision to a later date are not considered acceptable alternatives.

Step 3: Criteria. What are the key decision criteria that will guide decision-making? In a marketing course, for example, these may include relevant marketing criteria such as segmentation, positioning, advertising and sales, distribution, and pricing. Financial criteria useful in evaluating the alternatives should be included—for example, income statement variables, customer lifetime value, payback, etc. Students must discuss their rationale for selecting the decision criteria and the weights and importance for each factor.

Step 4: Analysis. Provide an in-depth analysis of each alternative based on the criteria chosen in step three. Decision tables using criteria as columns and alternatives as rows can be helpful. The pros and cons of the various choices as well as the short- and long-term implications of each may be evaluated. Best, worst, and most likely scenarios can also be insightful.

Step 5: Decision. Students propose their solution to the problem. This decision is justified based on an in-depth analysis. Explain why the recommendation made is the best fit for the criteria.

Step 6: Implementation plan. Sound business decisions may fail due to poor execution. To enhance the likeliness of a successful project outcome, students describe the key steps (activities) to implement the recommendation, timetable, projected costs, expected competitive reaction, success metrics, and risks in the plan.

“Students note that using the PACADI framework yields ‘aha moments’—they learned something surprising in the case that led them to think differently about the problem and their proposed solution.”

PACADI’s Benefits: Meaningfully and Thoughtfully Applying Business Concepts

The PACADI framework covers all of the major elements of business decision-making, including implementation, which is often overlooked. By stepping through the whole framework, students apply relevant business concepts and solve management problems via a systematic, comprehensive approach; they’re far less likely to surface piecemeal responses.

As students explore each part of the framework, they may realize that they need to make changes to a previous step. For instance, when working on implementation, students may realize that the alternative they selected cannot be executed or will not be profitable, and thus need to rethink their decision. Or, they may discover that the criteria need to be revised since the list of decision factors they identified is incomplete (for example, the factors may explain key marketing concerns but fail to address relevant financial considerations) or is unrealistic (for example, they suggest a 25 percent increase in revenues without proposing an increased promotional budget).

In addition, the PACADI framework can be used alongside quantitative assignments, in-class exercises, and business and management simulations. The structured, multi-step decision framework encourages careful and sequential analysis to solve business problems. Incorporating PACADI as an overarching decision-making method across different projects will ultimately help students achieve desired learning outcomes. As a practical “beyond-the-classroom” tool, the PACADI framework is not a contrived course assignment; it reflects the decision-making approach that managers, executives, and entrepreneurs exercise daily. Case analysis introduces students to the real-world process of making business decisions quickly and correctly, often with limited information. This framework supplies an organized and disciplined process that students can readily defend in writing and in class discussions.

PACADI in Action: An Example

Here’s an example of how students used the PACADI framework for a recent case analysis on CVS, a large North American drugstore chain.

The CVS Prescription for Customer Value*

PACADI Stage

Summary Response

How should CVS Health evolve from the “drugstore of your neighborhood” to the “drugstore of your future”?

Alternatives

A1. Kaizen (continuous improvement)

A2. Product development

A3. Market development

A4. Personalization (micro-targeting)

Criteria (include weights)

C1. Customer value: service, quality, image, and price (40%)

C2. Customer obsession (20%)

C3. Growth through related businesses (20%)

C4. Customer retention and customer lifetime value (20%)

Each alternative was analyzed by each criterion using a Customer Value Assessment Tool

Alternative 4 (A4): Personalization was selected. This is operationalized via: segmentation—move toward segment-of-1 marketing; geodemographics and lifestyle emphasis; predictive data analysis; relationship marketing; people, principles, and supply chain management; and exceptional customer service.

Implementation

Partner with leading medical school

Curbside pick-up

Pet pharmacy

E-newsletter for customers and employees

Employee incentive program

CVS beauty days

Expand to Latin America and Caribbean

Healthier/happier corner

Holiday toy drives/community outreach

*Source: A. Weinstein, Y. Rodriguez, K. Sims, R. Vergara, “The CVS Prescription for Superior Customer Value—A Case Study,” Back to the Future: Revisiting the Foundations of Marketing from Society for Marketing Advances, West Palm Beach, FL (November 2, 2018).

Results of Using the PACADI Framework

When faculty members at our respective institutions at Nova Southeastern University (NSU) and the University of North Carolina Wilmington have used the PACADI framework, our classes have been more structured and engaging. Students vigorously debate each element of their decision and note that this framework yields an “aha moment”—they learned something surprising in the case that led them to think differently about the problem and their proposed solution.

These lively discussions enhance individual and collective learning. As one external metric of this improvement, we have observed a 2.5 percent increase in student case grade performance at NSU since this framework was introduced.

Tips to Get Started

The PACADI approach works well in in-person, online, and hybrid courses. This is particularly important as more universities have moved to remote learning options. Because students have varied educational and cultural backgrounds, work experience, and familiarity with case analysis, we recommend that faculty members have students work on their first case using this new framework in small teams (two or three students). Additional analyses should then be solo efforts.

To use PACADI effectively in your classroom, we suggest the following:

Advise your students that your course will stress critical thinking and decision-making skills, not just course concepts and theory.

Use a varied mix of case studies. As marketing professors, we often address consumer and business markets; goods, services, and digital commerce; domestic and global business; and small and large companies in a single MBA course.

As a starting point, provide a short explanation (about 20 to 30 minutes) of the PACADI framework with a focus on the conceptual elements. You can deliver this face to face or through videoconferencing.

Give students an opportunity to practice the case analysis methodology via an ungraded sample case study. Designate groups of five to seven students to discuss the case and the six steps in breakout sessions (in class or via Zoom).

Ensure case analyses are weighted heavily as a grading component. We suggest 30–50 percent of the overall course grade.

Once cases are graded, debrief with the class on what they did right and areas needing improvement (30- to 40-minute in-person or Zoom session).

Encourage faculty teams that teach common courses to build appropriate instructional materials, grading rubrics, videos, sample cases, and teaching notes.

When selecting case studies, we have found that the best ones for PACADI analyses are about 15 pages long and revolve around a focal management decision. This length provides adequate depth yet is not protracted. Some of our tested and favorite marketing cases include Brand W , Hubspot , Kraft Foods Canada , TRSB(A) , and Whiskey & Cheddar .

Art Weinstein , Ph.D., is a professor of marketing at Nova Southeastern University, Fort Lauderdale, Florida. He has published more than 80 scholarly articles and papers and eight books on customer-focused marketing strategy. His latest book is Superior Customer Value—Finding and Keeping Customers in the Now Economy . Dr. Weinstein has consulted for many leading technology and service companies.

Herbert V. Brotspies , D.B.A., is an adjunct professor of marketing at Nova Southeastern University. He has over 30 years’ experience as a vice president in marketing, strategic planning, and acquisitions for Fortune 50 consumer products companies working in the United States and internationally. His research interests include return on marketing investment, consumer behavior, business-to-business strategy, and strategic planning.

John T. Gironda , Ph.D., is an assistant professor of marketing at the University of North Carolina Wilmington. His research has been published in Industrial Marketing Management, Psychology & Marketing , and Journal of Marketing Management . He has also presented at major marketing conferences including the American Marketing Association, Academy of Marketing Science, and Society for Marketing Advances.

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Creating a Patient-Centered Case Study

• First Online: 25 August 2023

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• Lisa Wesinger 6 ,
• Judi Gentes 7 ,
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Case studies provide an invaluable record of professional clinical practice and have been used in medicine since the late 1800s to describe both traditional and unusual presentations of specific disease pathologies. In medicine, case studies traditionally take a detached, objective approach to outlining the clinical course of a disease and its treatment. In keeping with the holistic approach to patient care found in nursing and using the theoretical foundations established in Jean Watson’s Theory of Human Caring as well as the Relationship-Based Care Model, this research team sought to revolutionize the case study paradigm and deconstruct the traditional case study approach, placing the patient, instead of the provider, at the center of the narrative. This new case study method intercalates the clinicians’ analysis of the case with the patient’s commentary. This chapter outlines the methods and theoretical underpinnings used to create a patient-centered case study and seeks to provide nurses with a creative alternative to the traditional, objective case study approach. Implications for future research include whether using patient-centered case studies, instead of traditional case studies, provide a valuable learning tool to educate nurses.

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Holl, J., Wesinger, L., Gentes, J., Morton, C., Coffey, J. (2023). Creating a Patient-Centered Case Study. In: Coffey, J., Hill Jr., J.M., Long, T., McGrath, E.B. (eds) Patients’ Lived Experiences During the Transplant and Cellular Therapy Journey. Springer, Cham. https://doi.org/10.1007/978-3-031-25602-8_2

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Creating a Corporate Social Responsibility Program with Real Impact

• Emilio Marti,
• David Risi,
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• Andromachi Athanasopoulou

Lessons from multinational companies that adapted their CSR practices based on local feedback and knowledge.

Exploring the critical role of experimentation in Corporate Social Responsibility (CSR), research on four multinational companies reveals a stark difference in CSR effectiveness. Successful companies integrate an experimental approach, constantly adapting their CSR practices based on local feedback and knowledge. This strategy fosters genuine community engagement and responsive initiatives, as seen in a mining company’s impactful HIV/AIDS program. Conversely, companies that rely on standardized, inflexible CSR methods often fail to achieve their goals, demonstrated by a failed partnership due to local corruption in another mining company. The study recommends encouraging broad employee participation in CSR and fostering a culture that values CSR’s long-term business benefits. It also suggests that sustainable investors and ESG rating agencies should focus on assessing companies’ experimental approaches to CSR, going beyond current practices to examine the involvement of diverse employees in both developing and adapting CSR initiatives. Overall, embracing a dynamic, data-driven approach to CSR is essential for meaningful social and environmental impact.

By now, almost all large companies are engaged in corporate social responsibility (CSR): they have CSR policies, employ CSR staff, engage in activities that aim to have a positive impact on the environment and society, and write CSR reports. However, the evolution of CSR has brought forth new challenges. A stark contrast to two decades ago, when the primary concern was the sheer neglect of CSR, the current issue lies in the ineffective execution of these practices. Why do some companies implement CSR in ways that create a positive impact on the environment and society, while others fail to do so? Our research reveals that experimentation is critical for impactful CSR, which has implications for both companies that implement CSR and companies that externally monitor these CSR activities, such as sustainable investors and ESG rating agencies.

• EM Emilio Marti is an associate professor at the Rotterdam School of Management, Erasmus University. His research focuses on corporate sustainability with a specific focus on sustainable investing.
• DR David Risi is a professor at the Bern University of Applied Sciences and a habilitated lecturer at the University of St. Gallen. His research focuses on how companies organize CSR and sustainability.
• ES Eva Schlindwein is a professor at the Bern University of Applied Sciences and a postdoctoral fellow at the University of Oxford. Her research focuses on how organizations navigate tensions between business and society.
• AA Andromachi Athanasopoulou is an associate professor at Queen Mary University of London and an associate fellow at the University of Oxford. Her research focuses on how individuals manage their leadership careers and make ethically charged decisions.

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Case study definition

Case study, a term which some of you may know from the "Case Study of Vanitas" anime and manga, is a thorough examination of a particular subject, such as a person, group, location, occasion, establishment, phenomena, etc. They are most frequently utilized in research of business, medicine, education and social behaviour. There are a different types of case studies that researchers might use:

• Collective case studies

• Descriptive case studies

• Explanatory case studies

• Exploratory case studies

• Instrumental case studies

• Intrinsic case studies

Case studies are usually much more sophisticated and professional than regular essays and courseworks, as they require a lot of verified data, are research-oriented and not necessarily designed to be read by the general public.

How to write a case study?

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• Your case scenario should be precisely defined in terms of your unique assessment criteria.

• Determine the primary issues by analyzing the scenario. Think about how they connect to the main ideas and theories in your piece.

• Find and investigate any theories or methods that might be relevant to your case.

• Keep your audience in mind. Exactly who are your stakeholder(s)? If writing a case study on coffee roasters, it's probably gonna be suppliers, landlords, investors, customers, etc.

• Indicate the best solution(s) and how they should be implemented. Make sure your suggestions are grounded in pertinent theories and useful resources, as well as being realistic, practical, and attainable.

• Carefully proofread your case study. Keep in mind these four principles when editing: clarity, honesty, reality and relevance.

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The case study approach

Sarah crowe.

1 Division of Primary Care, The University of Nottingham, Nottingham, UK

Kathrin Cresswell

2 Centre for Population Health Sciences, The University of Edinburgh, Edinburgh, UK

Ann Robertson

3 School of Health in Social Science, The University of Edinburgh, Edinburgh, UK

Anthony Avery

Aziz sheikh.

The case study approach allows in-depth, multi-faceted explorations of complex issues in their real-life settings. The value of the case study approach is well recognised in the fields of business, law and policy, but somewhat less so in health services research. Based on our experiences of conducting several health-related case studies, we reflect on the different types of case study design, the specific research questions this approach can help answer, the data sources that tend to be used, and the particular advantages and disadvantages of employing this methodological approach. The paper concludes with key pointers to aid those designing and appraising proposals for conducting case study research, and a checklist to help readers assess the quality of case study reports.

Introduction

The case study approach is particularly useful to employ when there is a need to obtain an in-depth appreciation of an issue, event or phenomenon of interest, in its natural real-life context. Our aim in writing this piece is to provide insights into when to consider employing this approach and an overview of key methodological considerations in relation to the design, planning, analysis, interpretation and reporting of case studies.

The illustrative 'grand round', 'case report' and 'case series' have a long tradition in clinical practice and research. Presenting detailed critiques, typically of one or more patients, aims to provide insights into aspects of the clinical case and, in doing so, illustrate broader lessons that may be learnt. In research, the conceptually-related case study approach can be used, for example, to describe in detail a patient's episode of care, explore professional attitudes to and experiences of a new policy initiative or service development or more generally to 'investigate contemporary phenomena within its real-life context' [ 1 ]. Based on our experiences of conducting a range of case studies, we reflect on when to consider using this approach, discuss the key steps involved and illustrate, with examples, some of the practical challenges of attaining an in-depth understanding of a 'case' as an integrated whole. In keeping with previously published work, we acknowledge the importance of theory to underpin the design, selection, conduct and interpretation of case studies[ 2 ]. In so doing, we make passing reference to the different epistemological approaches used in case study research by key theoreticians and methodologists in this field of enquiry.

This paper is structured around the following main questions: What is a case study? What are case studies used for? How are case studies conducted? What are the potential pitfalls and how can these be avoided? We draw in particular on four of our own recently published examples of case studies (see Tables ​ Tables1, 1 , ​ ,2, 2 , ​ ,3 3 and ​ and4) 4 ) and those of others to illustrate our discussion[ 3 - 7 ].

Example of a case study investigating the reasons for differences in recruitment rates of minority ethnic people in asthma research[ 3 ]

Example of a case study investigating the process of planning and implementing a service in Primary Care Organisations[ 4 ]

Example of a case study investigating the introduction of the electronic health records[ 5 ]

Example of a case study investigating the formal and informal ways students learn about patient safety[ 6 ]

What is a case study?

A case study is a research approach that is used to generate an in-depth, multi-faceted understanding of a complex issue in its real-life context. It is an established research design that is used extensively in a wide variety of disciplines, particularly in the social sciences. A case study can be defined in a variety of ways (Table ​ (Table5), 5 ), the central tenet being the need to explore an event or phenomenon in depth and in its natural context. It is for this reason sometimes referred to as a "naturalistic" design; this is in contrast to an "experimental" design (such as a randomised controlled trial) in which the investigator seeks to exert control over and manipulate the variable(s) of interest.

Definitions of a case study

Stake's work has been particularly influential in defining the case study approach to scientific enquiry. He has helpfully characterised three main types of case study: intrinsic , instrumental and collective [ 8 ]. An intrinsic case study is typically undertaken to learn about a unique phenomenon. The researcher should define the uniqueness of the phenomenon, which distinguishes it from all others. In contrast, the instrumental case study uses a particular case (some of which may be better than others) to gain a broader appreciation of an issue or phenomenon. The collective case study involves studying multiple cases simultaneously or sequentially in an attempt to generate a still broader appreciation of a particular issue.

These are however not necessarily mutually exclusive categories. In the first of our examples (Table ​ (Table1), 1 ), we undertook an intrinsic case study to investigate the issue of recruitment of minority ethnic people into the specific context of asthma research studies, but it developed into a instrumental case study through seeking to understand the issue of recruitment of these marginalised populations more generally, generating a number of the findings that are potentially transferable to other disease contexts[ 3 ]. In contrast, the other three examples (see Tables ​ Tables2, 2 , ​ ,3 3 and ​ and4) 4 ) employed collective case study designs to study the introduction of workforce reconfiguration in primary care, the implementation of electronic health records into hospitals, and to understand the ways in which healthcare students learn about patient safety considerations[ 4 - 6 ]. Although our study focusing on the introduction of General Practitioners with Specialist Interests (Table ​ (Table2) 2 ) was explicitly collective in design (four contrasting primary care organisations were studied), is was also instrumental in that this particular professional group was studied as an exemplar of the more general phenomenon of workforce redesign[ 4 ].

What are case studies used for?

According to Yin, case studies can be used to explain, describe or explore events or phenomena in the everyday contexts in which they occur[ 1 ]. These can, for example, help to understand and explain causal links and pathways resulting from a new policy initiative or service development (see Tables ​ Tables2 2 and ​ and3, 3 , for example)[ 1 ]. In contrast to experimental designs, which seek to test a specific hypothesis through deliberately manipulating the environment (like, for example, in a randomised controlled trial giving a new drug to randomly selected individuals and then comparing outcomes with controls),[ 9 ] the case study approach lends itself well to capturing information on more explanatory ' how ', 'what' and ' why ' questions, such as ' how is the intervention being implemented and received on the ground?'. The case study approach can offer additional insights into what gaps exist in its delivery or why one implementation strategy might be chosen over another. This in turn can help develop or refine theory, as shown in our study of the teaching of patient safety in undergraduate curricula (Table ​ (Table4 4 )[ 6 , 10 ]. Key questions to consider when selecting the most appropriate study design are whether it is desirable or indeed possible to undertake a formal experimental investigation in which individuals and/or organisations are allocated to an intervention or control arm? Or whether the wish is to obtain a more naturalistic understanding of an issue? The former is ideally studied using a controlled experimental design, whereas the latter is more appropriately studied using a case study design.

Case studies may be approached in different ways depending on the epistemological standpoint of the researcher, that is, whether they take a critical (questioning one's own and others' assumptions), interpretivist (trying to understand individual and shared social meanings) or positivist approach (orientating towards the criteria of natural sciences, such as focusing on generalisability considerations) (Table ​ (Table6). 6 ). Whilst such a schema can be conceptually helpful, it may be appropriate to draw on more than one approach in any case study, particularly in the context of conducting health services research. Doolin has, for example, noted that in the context of undertaking interpretative case studies, researchers can usefully draw on a critical, reflective perspective which seeks to take into account the wider social and political environment that has shaped the case[ 11 ].

Example of epistemological approaches that may be used in case study research

How are case studies conducted?

Here, we focus on the main stages of research activity when planning and undertaking a case study; the crucial stages are: defining the case; selecting the case(s); collecting and analysing the data; interpreting data; and reporting the findings.

Defining the case

Carefully formulated research question(s), informed by the existing literature and a prior appreciation of the theoretical issues and setting(s), are all important in appropriately and succinctly defining the case[ 8 , 12 ]. Crucially, each case should have a pre-defined boundary which clarifies the nature and time period covered by the case study (i.e. its scope, beginning and end), the relevant social group, organisation or geographical area of interest to the investigator, the types of evidence to be collected, and the priorities for data collection and analysis (see Table ​ Table7 7 )[ 1 ]. A theory driven approach to defining the case may help generate knowledge that is potentially transferable to a range of clinical contexts and behaviours; using theory is also likely to result in a more informed appreciation of, for example, how and why interventions have succeeded or failed[ 13 ].

Example of a checklist for rating a case study proposal[ 8 ]

For example, in our evaluation of the introduction of electronic health records in English hospitals (Table ​ (Table3), 3 ), we defined our cases as the NHS Trusts that were receiving the new technology[ 5 ]. Our focus was on how the technology was being implemented. However, if the primary research interest had been on the social and organisational dimensions of implementation, we might have defined our case differently as a grouping of healthcare professionals (e.g. doctors and/or nurses). The precise beginning and end of the case may however prove difficult to define. Pursuing this same example, when does the process of implementation and adoption of an electronic health record system really begin or end? Such judgements will inevitably be influenced by a range of factors, including the research question, theory of interest, the scope and richness of the gathered data and the resources available to the research team.

Selecting the case(s)

The decision on how to select the case(s) to study is a very important one that merits some reflection. In an intrinsic case study, the case is selected on its own merits[ 8 ]. The case is selected not because it is representative of other cases, but because of its uniqueness, which is of genuine interest to the researchers. This was, for example, the case in our study of the recruitment of minority ethnic participants into asthma research (Table ​ (Table1) 1 ) as our earlier work had demonstrated the marginalisation of minority ethnic people with asthma, despite evidence of disproportionate asthma morbidity[ 14 , 15 ]. In another example of an intrinsic case study, Hellstrom et al.[ 16 ] studied an elderly married couple living with dementia to explore how dementia had impacted on their understanding of home, their everyday life and their relationships.

For an instrumental case study, selecting a "typical" case can work well[ 8 ]. In contrast to the intrinsic case study, the particular case which is chosen is of less importance than selecting a case that allows the researcher to investigate an issue or phenomenon. For example, in order to gain an understanding of doctors' responses to health policy initiatives, Som undertook an instrumental case study interviewing clinicians who had a range of responsibilities for clinical governance in one NHS acute hospital trust[ 17 ]. Sampling a "deviant" or "atypical" case may however prove even more informative, potentially enabling the researcher to identify causal processes, generate hypotheses and develop theory.

In collective or multiple case studies, a number of cases are carefully selected. This offers the advantage of allowing comparisons to be made across several cases and/or replication. Choosing a "typical" case may enable the findings to be generalised to theory (i.e. analytical generalisation) or to test theory by replicating the findings in a second or even a third case (i.e. replication logic)[ 1 ]. Yin suggests two or three literal replications (i.e. predicting similar results) if the theory is straightforward and five or more if the theory is more subtle. However, critics might argue that selecting 'cases' in this way is insufficiently reflexive and ill-suited to the complexities of contemporary healthcare organisations.

The selected case study site(s) should allow the research team access to the group of individuals, the organisation, the processes or whatever else constitutes the chosen unit of analysis for the study. Access is therefore a central consideration; the researcher needs to come to know the case study site(s) well and to work cooperatively with them. Selected cases need to be not only interesting but also hospitable to the inquiry [ 8 ] if they are to be informative and answer the research question(s). Case study sites may also be pre-selected for the researcher, with decisions being influenced by key stakeholders. For example, our selection of case study sites in the evaluation of the implementation and adoption of electronic health record systems (see Table ​ Table3) 3 ) was heavily influenced by NHS Connecting for Health, the government agency that was responsible for overseeing the National Programme for Information Technology (NPfIT)[ 5 ]. This prominent stakeholder had already selected the NHS sites (through a competitive bidding process) to be early adopters of the electronic health record systems and had negotiated contracts that detailed the deployment timelines.

It is also important to consider in advance the likely burden and risks associated with participation for those who (or the site(s) which) comprise the case study. Of particular importance is the obligation for the researcher to think through the ethical implications of the study (e.g. the risk of inadvertently breaching anonymity or confidentiality) and to ensure that potential participants/participating sites are provided with sufficient information to make an informed choice about joining the study. The outcome of providing this information might be that the emotive burden associated with participation, or the organisational disruption associated with supporting the fieldwork, is considered so high that the individuals or sites decide against participation.

In our example of evaluating implementations of electronic health record systems, given the restricted number of early adopter sites available to us, we sought purposively to select a diverse range of implementation cases among those that were available[ 5 ]. We chose a mixture of teaching, non-teaching and Foundation Trust hospitals, and examples of each of the three electronic health record systems procured centrally by the NPfIT. At one recruited site, it quickly became apparent that access was problematic because of competing demands on that organisation. Recognising the importance of full access and co-operative working for generating rich data, the research team decided not to pursue work at that site and instead to focus on other recruited sites.

Collecting the data

In order to develop a thorough understanding of the case, the case study approach usually involves the collection of multiple sources of evidence, using a range of quantitative (e.g. questionnaires, audits and analysis of routinely collected healthcare data) and more commonly qualitative techniques (e.g. interviews, focus groups and observations). The use of multiple sources of data (data triangulation) has been advocated as a way of increasing the internal validity of a study (i.e. the extent to which the method is appropriate to answer the research question)[ 8 , 18 - 21 ]. An underlying assumption is that data collected in different ways should lead to similar conclusions, and approaching the same issue from different angles can help develop a holistic picture of the phenomenon (Table ​ (Table2 2 )[ 4 ].

Brazier and colleagues used a mixed-methods case study approach to investigate the impact of a cancer care programme[ 22 ]. Here, quantitative measures were collected with questionnaires before, and five months after, the start of the intervention which did not yield any statistically significant results. Qualitative interviews with patients however helped provide an insight into potentially beneficial process-related aspects of the programme, such as greater, perceived patient involvement in care. The authors reported how this case study approach provided a number of contextual factors likely to influence the effectiveness of the intervention and which were not likely to have been obtained from quantitative methods alone.

In collective or multiple case studies, data collection needs to be flexible enough to allow a detailed description of each individual case to be developed (e.g. the nature of different cancer care programmes), before considering the emerging similarities and differences in cross-case comparisons (e.g. to explore why one programme is more effective than another). It is important that data sources from different cases are, where possible, broadly comparable for this purpose even though they may vary in nature and depth.

Analysing, interpreting and reporting case studies

Making sense and offering a coherent interpretation of the typically disparate sources of data (whether qualitative alone or together with quantitative) is far from straightforward. Repeated reviewing and sorting of the voluminous and detail-rich data are integral to the process of analysis. In collective case studies, it is helpful to analyse data relating to the individual component cases first, before making comparisons across cases. Attention needs to be paid to variations within each case and, where relevant, the relationship between different causes, effects and outcomes[ 23 ]. Data will need to be organised and coded to allow the key issues, both derived from the literature and emerging from the dataset, to be easily retrieved at a later stage. An initial coding frame can help capture these issues and can be applied systematically to the whole dataset with the aid of a qualitative data analysis software package.

The Framework approach is a practical approach, comprising of five stages (familiarisation; identifying a thematic framework; indexing; charting; mapping and interpretation) , to managing and analysing large datasets particularly if time is limited, as was the case in our study of recruitment of South Asians into asthma research (Table ​ (Table1 1 )[ 3 , 24 ]. Theoretical frameworks may also play an important role in integrating different sources of data and examining emerging themes. For example, we drew on a socio-technical framework to help explain the connections between different elements - technology; people; and the organisational settings within which they worked - in our study of the introduction of electronic health record systems (Table ​ (Table3 3 )[ 5 ]. Our study of patient safety in undergraduate curricula drew on an evaluation-based approach to design and analysis, which emphasised the importance of the academic, organisational and practice contexts through which students learn (Table ​ (Table4 4 )[ 6 ].

Case study findings can have implications both for theory development and theory testing. They may establish, strengthen or weaken historical explanations of a case and, in certain circumstances, allow theoretical (as opposed to statistical) generalisation beyond the particular cases studied[ 12 ]. These theoretical lenses should not, however, constitute a strait-jacket and the cases should not be "forced to fit" the particular theoretical framework that is being employed.

When reporting findings, it is important to provide the reader with enough contextual information to understand the processes that were followed and how the conclusions were reached. In a collective case study, researchers may choose to present the findings from individual cases separately before amalgamating across cases. Care must be taken to ensure the anonymity of both case sites and individual participants (if agreed in advance) by allocating appropriate codes or withholding descriptors. In the example given in Table ​ Table3, 3 , we decided against providing detailed information on the NHS sites and individual participants in order to avoid the risk of inadvertent disclosure of identities[ 5 , 25 ].

What are the potential pitfalls and how can these be avoided?

The case study approach is, as with all research, not without its limitations. When investigating the formal and informal ways undergraduate students learn about patient safety (Table ​ (Table4), 4 ), for example, we rapidly accumulated a large quantity of data. The volume of data, together with the time restrictions in place, impacted on the depth of analysis that was possible within the available resources. This highlights a more general point of the importance of avoiding the temptation to collect as much data as possible; adequate time also needs to be set aside for data analysis and interpretation of what are often highly complex datasets.

Case study research has sometimes been criticised for lacking scientific rigour and providing little basis for generalisation (i.e. producing findings that may be transferable to other settings)[ 1 ]. There are several ways to address these concerns, including: the use of theoretical sampling (i.e. drawing on a particular conceptual framework); respondent validation (i.e. participants checking emerging findings and the researcher's interpretation, and providing an opinion as to whether they feel these are accurate); and transparency throughout the research process (see Table ​ Table8 8 )[ 8 , 18 - 21 , 23 , 26 ]. Transparency can be achieved by describing in detail the steps involved in case selection, data collection, the reasons for the particular methods chosen, and the researcher's background and level of involvement (i.e. being explicit about how the researcher has influenced data collection and interpretation). Seeking potential, alternative explanations, and being explicit about how interpretations and conclusions were reached, help readers to judge the trustworthiness of the case study report. Stake provides a critique checklist for a case study report (Table ​ (Table9 9 )[ 8 ].

Potential pitfalls and mitigating actions when undertaking case study research

Stake's checklist for assessing the quality of a case study report[ 8 ]

Conclusions

The case study approach allows, amongst other things, critical events, interventions, policy developments and programme-based service reforms to be studied in detail in a real-life context. It should therefore be considered when an experimental design is either inappropriate to answer the research questions posed or impossible to undertake. Considering the frequency with which implementations of innovations are now taking place in healthcare settings and how well the case study approach lends itself to in-depth, complex health service research, we believe this approach should be more widely considered by researchers. Though inherently challenging, the research case study can, if carefully conceptualised and thoughtfully undertaken and reported, yield powerful insights into many important aspects of health and healthcare delivery.

Competing interests

The authors declare that they have no competing interests.

Authors' contributions

AS conceived this article. SC, KC and AR wrote this paper with GH, AA and AS all commenting on various drafts. SC and AS are guarantors.

Pre-publication history

The pre-publication history for this paper can be accessed here:

http://www.biomedcentral.com/1471-2288/11/100/prepub

Acknowledgements

We are grateful to the participants and colleagues who contributed to the individual case studies that we have drawn on. This work received no direct funding, but it has been informed by projects funded by Asthma UK, the NHS Service Delivery Organisation, NHS Connecting for Health Evaluation Programme, and Patient Safety Research Portfolio. We would also like to thank the expert reviewers for their insightful and constructive feedback. Our thanks are also due to Dr. Allison Worth who commented on an earlier draft of this manuscript.

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Case study - Creating a Methodology Background John Compton, the...

Case study - Creating a Methodology

John Compton, the president of the company, expressed his feelings quite bluntly at the executive staff meeting:

We are no longer competitive in the marketplace. Almost all of the Requests for Proposal (RFP) that we want to bid on have a requirement that we must identify in the proposal the project management methodology we will use on the contract should we be awarded the contract. We have no project management methodology. We have just a few templates we use based upon the PMBOK® Guide. All of our competitors have methodologies, but not us.

I have been asking for a methodology to be developed for more than a year now, and all I get are excuses. Some of you are obviously afraid that you might lose power and authority once the methodology is up and running. That may be true, but losing some power and authority is obviously better than losing your job. In six months, I want to see a methodology in use on all projects or I will handle the situation myself. I simply cannot believe that my executive staff is afraid to develop a project management methodology.

Critical Issues

The executive staff knew this day was inevitable; they had to take the initiative in the implementation of a project management methodology. Last year, a consultant was brought in to conduct a morning three-hour session on the benefits of project management and the value of an enterprise project management methodology (EPM). As part of the session, the consultant explained that the time needed to develop and implement an EPM system can be shortened if the company has a project management office (PMO) in place to take the lead role. The consultant also explained that whichever executive gets control of the PMO may become more powerful than other executives because he or she now controls all of the project management intellectual property. The executive staff fully understood the implication of this and therefore became reluctant to visibly support project management until they could see how their organization would be affected. In the meantime, project management suffered.

Reluctantly, a PMO was formed reporting to the chief information officer. The PMO comprised a handful of experienced project managers who could hopefully take the lead in the development of a methodology. The PMO concluded that there were five steps that had to be done initially. After the five steps were done, the executive committee would receive a final briefing on what had been accomplished. The final briefing would be in addition to the monthly updates and progress reports. The PMO believed that getting executive support and sign-offs in a timely manner would be difficult.

The first step that needed to be done was the establishment of the number of life-cycle phases. Some people interviewed wanted ten to twelve life-cycle phases. That meant that there would be ten to twelve gate review meetings and the project managers would spend a great deal of time preparing paperwork for the gate review meetings rather than managing the project. The decision was then made to have no more than six life-cycle phases.

The second step was to decide whether the methodology should be designed around rigid policies and procedures or go the more informal route of using forms, guidelines, checklists, and templates. The PMO felt that project managers needed some degree of freedom in dealing with clients and therefore the more informal approach would work best. Also, clients were asking to have the methodology designed around the client's business needs and the more informal approach would provide the flexibility.

The third step was to see what could be salvaged from the existing templates and checklists. The company had a few templates and checklists but not all of the project managers used them. The decision was made to develop a standardized set of documents in accordance with the information in the PMBOK® Guide. The project managers could then select whatever forms, guidelines, templates, and checklists were appropriate for a particular project and client.

The fourth step would be to develop a means for capturing best practices using the EPM system. Clients were now requiring in their RFP that best practices on a project must be captured and shared with the client prior to the closeout of the project. Most of the people in the PMO believed that this could be done using forms or checklists at the final project debriefing meeting.

The fifth step involved education and training. The project managers and functional organizations that would staff the projects would need to be trained in the use of the new methodology. The PMO believed that a one-day training program would suffice and the functional organizations could easily release their people for a one-day training session.

• What can you determine about the corporate culture from the fact that they waited this long to consider the development of an EPM system?
• Can a PMO accelerate the implementation process?
• Is it acceptable for the PMO to report to the chief information officer or to someone else?
• Why is it best to have six or fewer life-cycle phases in an EPM system?
• Is it best to design an EPM system around flexible or inflexible elements? Generally, when first developing an EPM system, do companies prefer to use formality or informality in the design?
• Should an EPM system have the capability of capturing best practices?

Please provide detailed description.

Note: Provide References at the end.

Answer & Explanation

Question 1. Because they put off thinking about developing an EPM system for so long, the company culture is one that is hostile to change and wary of ceding control. Question 2. By taking the lead in developing the approach and obtaining executive backing and sign-offs quickly, a PMO may hasten the implementation process. Question 3. The PMO may report to the chief of information or to another person. Question 4. In order for project managers to spend more managing business project and less time preparing documentation for gate review meetings, it is ideal for an EPM system to have six or fewer life-cycle stages. Question 5. To make an EPM system readily adaptable to the client's business demands, it is ideal to build it around flexible components. Question 6 In order to readily update and adjust the system as required, firms often opt to employ an informal design when creating their initial EPM system. Question 7. Best practices should be able to be recorded by an EPM system so they may be shared with the customer before the project is finished.

• The executive staff's fear of losing their positions of authority and influence is the reason why the corporate culture is resistant to change. Due to the fact that they would be in charge of the PMO and have complete control over all project management intellectual property, the executive staff is frightened of losing their position of power and dominance. The executive staff is averse to publicly demonstrating their support for managing projects since they do not want to seem to be in favor of a system that may provide them an advantage over other executives.
• Because they do not want to be viewed as backing a system that may provide them an advantage over other executives, the executive staff is hesitant to endorse project management. Due to the fact that they would be in charge of the PMO and have complete control over all project management intellectual property, the executive staff is frightened of losing their position of power and dominance. The executive staff is averse to publicly demonstrating their support for program management since they do not want to seem to be in favor of a system that may provide them an advantage over other executives.
• Because they are concerned about losing their position of authority and control, the executive staff is hesitant to endorse project management. They would be in command of the PMO and have complete control over all of the program delivery intellectual property, therefore they are terrified of losing control and authority. The executive staff is averse to publicly demonstrating their support for project management because they do not want to seem to be in favor of a system that may provide them an advantage over other executives.

Question 2.

• By creating a collection of standard papers in line with the details in the PMBOK® Guide, a PMO may take the responsibility for the creation of the methodology. By holding a morning three-hour seminar on the advantages of managing projects and the worth of an EPM system, the PMO may also get executive support and approvals in a timely way.
• A morning three-hour lecture on the advantages of managing projects and the worth of an EPM system may help a PMO quickly get senior backing and sign-offs. By creating a collection of standardized papers in line with the details in the PMBOK® Guide, the PMO may also assume the lead role in the creation of the methodology.
• By creating a collection of standardized papers in line with the details in the PMBOK® Guide, the PMO may assume the lead position in the development of the methodology. By holding a morning three-hour seminar on the advantages of project management and the worth of an EPM system, the PMO may also get executive support and approvals in a timely way.

Question 3.

• The executive staff is unwilling to publicly embrace project management, hence it is okay for the PMO to answer to the CIO. Because the PMO is in charge of developing the technique, it is also permissible for the PMO to report to someone else.
• Given that the PMO is in charge of developing the approach, reporting to someone else is permissible. Because the executive staff is hesitant to publicly embrace project management, it is also permissible for the PMO to subordinate to the chief information officers.
• The executive staff is hesitant to openly embrace project management, and the PMO is in charge of developing the approach. As a result, the PMO may report to the chief data officer or to another individual.

Question 4.

• In order to allow construction companies to spend more time administering the project, an EPM system should include six or fewer life-cycle stages. This is due to the fact that if there were ten to twelve life-cycle stages, project managers would have to
• spend a lot of time creating documentation for gate review meetings. If there were ten to twelve life-cycle stages, project managers would spend a lot of time preparing documents for gate review meetings. So that project managers can devote more time to managing the project, it is ideal to have six or fewer life-cycle stages.
• If there were ten to 12 life-cycle stages, project managers would have to spend a lot of time preparing documents for gate review meetings. Therefore, it is ideal for an EPM system to contain six life-cycle stages or less so that project managers may devote more time to managing the project.

Question 5.

• To make an EPM system readily adaptable to the client's business demands, it is ideal to build it around flexible components. This is because customers want the technique to be tailored to their specific business needs, whereas a more flexible approach will provide them that freedom.
• Customers want the technique to be tailored to their specific business requirements, and the more flexible approach will deliver on that need. Therefore, it is better to build an EPM system with adaptable components.
• The more adaptable strategy will allow for the flexibility in technique design that customers are requesting. Therefore, it is better to create an EPM system with adaptable components.

Question 6. 

• In general, businesses choose to employ casualness in the design when creating their initial EPM system. This is due to the fact that the more casual approach will allow for the flexibility required to quickly alter and adjust the system as necessary.
• The less formal strategy will allow for the flexibility required to quickly modify and adjust the system as necessary. Therefore, businesses often opt to employ informality in the design when creating their initial EPM system.
• The EPM system must be flexible in order to be quickly modified and customized as required. As a result, firms often opt to employ informality in the design while establishing an EPM system in the beginning.

Question 7.

• Best practices should be able to be recorded by an EPM system so they may be shared with the customer before the project is finished. This is due to the fact that customers are increasingly stipulating in their RFP that appropriate procedures on a program must be recorded and communicated to the client before the project is closed.
• Standard procedures on such a project must now be documented and communicated to the customer before the project is closed off, according to a recent trend in client RFPs. Therefore, best practices should be able to be recorded by an EPM system.
• Prior to the project's closeout, appropriate procedures must be documented and communicated to the customer. Therefore, best practices should be able to be recorded by an EPM system.

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• Open access
• Published: 05 April 2024

The clinical trial activation process: a case study of an Italian public hospital

• Carolina Pelazza   ORCID: orcid.org/0000-0002-7875-3710 1 ,
• Marta Betti 1 ,
• Francesca Marengo 1 ,
• Annalisa Roveta 2 &
• Antonio Maconi 1  

Trials volume  25 , Article number:  240 ( 2024 ) Cite this article

Metrics details

Background/aims

In order to make the centers more attractive to trial sponsors, in recent years, some research institutions around the world have pursued projects to reorganize the pathway of trial activation, developing new organizational models to improve the activation process and reduce its times.

This study aims at analyzing and reorganizing the start-up phase of trials conducted at the Research and Innovation Department (DAIRI) of the Public Hospital of Alessandria (Italy).

A project was carried out to reorganize the trial authorization process at DAIRI by involving the three facilities responsible for this pathway: clinical trial center (CTC), ethics committee secretariat (ESC), and administrative coordination (AC).

Lean Thinking methodology was used with the A3 report tool, and the analysis was carried out by monitoring specific key performance indicators, derived from variables representing highlights of the trials’ activation pathway.

The project involved phases of analysis, implementation of identified countermeasures, and monitoring of timelines in eight 4-month periods.

The overall mean and median values of studies activation times were calculated as well as the average times for each facility involved in the process.

In this study, 298 studies both sponsored by research associations and industry with both observational and interventional study design were monitored.

The mean trial activation time was reduced from 218 days before the project to 56 days in the last period monitored.

From the first to the last monitoring period, each facility involved achieved at least a halving of the average time required to carry out its activities in the clinical trials’ activation pathway (CTC: 55 days vs 23, ECS: 25 days vs 8, AC 29 days vs 10).

Average activation time for studies with agreement remains longer than those without agreement (100 days vs. 46).

Conclusions

The reorganization project emphasized the importance of having clinical and administrative staff specifically trained on the trial activation process.

This reorganization led to the development of a standard operating procedure and a tool to monitor the time (KPIs of the process) that can also be implemented in other clinical centers.

Peer Review reports

Introduction

In the European context, Italy continues to represent a geographical area of great interest for clinical research, an indispensable activity not only for its value in terms of economic investment made in the national territory but also for the opportunity offered to this country to improve clinical practice, grant timely access to therapies to patients, and, more generally, growth.

The scientific excellence of the various Italian trial centers is unfortunately often penalized by the slow process of activating clinical trials, which goes so far as affect Italy’s participation in international studies [ 1 ]. This slowness very often is due to the following: (1) a large number of ethics committees and not always adequate; (2) a lack of availability of research infrastructure including dedicated administrative and clinical staff; (3) a complex regulative process [ 2 ].

Clinical trials can only start if they have obtained a favorable opinion from the ethics committee. In Italy, interventional pharmacological and medical devices studies also require approval from the competent authorities, Italian Drug Agency (AIFA) and the Ministry of Health, respectively. The request for authorization is based on a complete dossier that includes the study protocol and informed consent for the patient as well as all available information about the experimental products, if any. The structure of the trial dossier is standard and meets the requirements identified in European legislation and transposed into national one, which refer to international scientific standards [ 3 ]. State-specific regulations therefore have an impact on the initial phase of trial activation, which therefore makes this phase one of the most complex and costly for sponsors who decide to undertake the initiation of new studies [ 4 , 5 ].

Currently, through the application of the European Clinical Trials Regulation No. 536/14 [ 6 ], this pathway is undergoing a significant reorganization, including a harmonization of clinical trial assessment decisions and administrative processes. This new pathway is fully adopted as of January 2023.

Notwithstanding the quality that a clinical center can demonstrate in the research setting, in terms of qualified personnel and facilities available, the selection of centers conducted by trial sponsors also relies heavily on the timelines required for trial activation. For a clinical center to be selected as a participant in a trial, it must represent an opportunity to provide innovative treatment to its patients. In particular, in trials involving competitive enrollment among participating centers, rapid process for its activation allows a higher rate of recruitment of patients eligible for the experimental treatment.

Difficulties encountered in trial activation have been identified for studies in different therapeutics areas, and pathways have been studied for both industry-sponsored and investigator-sponsored studies [ 7 , 8 , 9 ]. In order to make the centers more attractive, in recent years, some research institutes have carried out projects to internally reorganize the pathway for trial activation, identifying the main critical issues and developing new organizational models with a reduction of the time for the start-up phase of trials [ 10 , 11 , 12 ]. None of these projects have so far been performed in Italian centers.

This study aims at analyzing and reorganizing the start-up phase of trials conducted at the Research and Innovation Department (DAIRI) of the public hospital “SS Antonio e Biagio e Cesare Arrigo” of Alessandria (AO AL) in Piedmont region (Italy).

Materials and methods

In the period from November 2019 to August 2022, a project about the reorganization of the trial authorization process was carried out at DAIRI.

Setting and participants

This process involved different facilities (clinical trial center, ethic committee secretariat, and administrative coordination), everyone with specific roles. The clinical trial center (CTC) was responsible for conducting an assessment of the trial for scientific and economic aspects as well as checking the completeness of the trial dossier provided by the sponsor. Once the assessment has been carried out, the CTC forwards the trial documentation to the secretariat of the Ethic Committee (ECS), which was responsible for including it in the first useful meeting of the Ethic Committee (EC) and producing the minutes of approval. The administrative coordination (AC) was responsible for negotiating the agreement when required and preparing the authorization act for the conduct of the trial at AO AL.

Prior to the start of the project, in September 2019, the trial activation process consisted of these three phases that took place consecutively, and the average time of this process at the hospital was 218 days.

Lean methodology

The system development methodology refers to the Lean Thinking, a new way to organize processes and activities in different scenarios, including HealthCare, in order to eliminate waste and to optimize resources and to create more value to individuals [ 13 , 14 ].

Lean Thinking encourages the practice of continuous improvement and is based on the fundamental idea of respect for people. The basis of performance management is the effective use of resources, as measured by quantifying processes and outcomes using key performance indicators (KPIs) [ 15 ].

We used the “A3 report” both in the communication process within the team and as a tool for describing, analyzing, and solving the problem (see Additional file 1 : Table S1).

The A3 report reflects the results of the whole process, in several different steps:

Problem description: to clarify the problem and briefly describe it

Current situation: to describe the current situation in the area where the issue appears and to map the process as it is

Root cause analysis: to know and fight the root cause of the problem

Targets/goals: to set goals and step by step to go to the end, also by coming back to previous step and add more details to the initial goals

Countermeasures: to find and apply solutions

Implementation: to present an implementation plan of the actions that will be applied

Results/follow-up: to measure the results and confirm the effect of the applied countermeasures; the step is crucial to set up a continuous improvement

In order to measure and quantify the process improvement, we chose appropriate KPIs (Table  1 ), and we monitored them by using a graphical dashboard.

The project

In the first phase of the project, the trial activation process was reviewed as a whole, and all the steps were evaluated to identify initial countermeasures with the aim of streamlining processes and reducing waste. In the second phase of the project, the implementation of the identified countermeasures and the beginning of the new trial activation process was initiated.

After testing these countermeasures, a monitoring period (November 2019–February 2020) of the timeframe of studies activation was carried out, from which additional and more refined countermeasures useful for achieving process standardization emerged. Following the introduction of the last countermeasures, a new phase of monitoring the timing of trial activation started (May 2020–September 2020).

The monitoring period continued even throughout 2021 until August 2022. We defined further six quarters, from September 2020 to August 2022. In each period, we considered all the studies submitted to the local EC.

In order to monitor the timelines related to the process of trials’ activation, a database already in use at the CTC for monitoring active studies was implemented. The variables identified for timing monitoring were based on the activities carried out by the three facilities (CTC, ECS, AC): date of receipt of trials’ documentation, date of completion of documentation and economic and scientific evaluation, date of transmission of trials’ dossier, date of ethics committee meeting, date of issuance of approval minutes, date of start and end of agreement negotiation (if any), date of authorization by the AO AL, date of last signing of the agreement. We considered all trials sponsored by companies or non-profit institutions. For studies sponsored by AO AL, the time of study design and planning was not considered; thus, the time of activation was monitored, since the protocol and attached documents were completed.

The overall mean and median values of studies activation times were calculated as well as the average times for each facility involved in the process. Median activation time values were also calculated by dividing studies with and without an agreement.

During the eight periods between November 2019 and August 2022, 298 trials were monitored (Table  2 ).

Of these, 282 were activated at AO AL, while 13 received conditional or suspensive opinion from the local EC with no response from the sponsor within the defined timeframe, 2 received a negative opinion from the national competent authority (i.e., AIFA), and 1 was withdrawn by the sponsor.

Of the 298 studies, 98 were interventional (e.g., studies on the evaluation of innovative drug therapies or medical devices or the study of diagnostic, surgical, or assistive procedures). The other 200 studies were epidemiological or observational pharmacological or observational medical device studies. Regarding the nature of the studies monitored, 56 were for-profit, while 242 were sponsored by research associations or no-profit organizations. Of all the studies considered, 100 involved the signing of an agreement between the sponsor and the AO AL to conduct the study, not only limited to industry-sponsored studies.

The 298 studies examined in the project were not related to COVID-19 because all trials on this specific topic followed a faster activation process due to national regulations.

As a result of the reorganization project, the mean trial activation time was reduced from 123 and 110 days in the first two periods monitored to 56 days in the last period from May to August 2022 (Fig.  1 ).

Mean and median activation times of the trials considered in each monitoring period

Median values decreased from 81 days in period I to 55 days in period II to 31 days in the last two periods monitored.

From the first to the last monitoring period, each facility involved achieved at least a halving of the average time required to carry out its activities in the clinical trials’ activation pathway (Fig.  2 ).

Average times recorded for carrying out the activities of each individual sector in the first and last monitoring period of the trial activation pathway

The average time to carry out CTC activities decreased from 55 to 23 days. The time between the completion of the documentation by the CTC and the submission of the study to the EC cannot be less than 15 days because this is a fixed time stipulated by the study activation procedure. The time required for the ECS to issue approval has decreased from an average of 25 days to 8 days. The time required for approval by the institute, carried out by the AC after EC approval, decreased from an average of 29 days to 10 days.

The activation process for studies that do not involve an agreement between sponsor and AO AL has gone from an average time of 91 days in the period from November 2019 to February 2020 to an average of 47 days in the last time frame. The average time frame for activation of studies with agreement has decreased from 159 days in the initial phase to 100 in the last period considered (Fig.  3 ).

Comparison of the average activation time of trials with and without agreement in the first and last monitoring period

The agreement finalization time (from the beginning of text negotiation to final signature) decreased from 117 to 69 days in the last monitored period.

The current average time of the clinical trial activation process is 56 days and is more influenced by the larger number of studies that do not have agreements and therefore take less time to complete the activation process.

Analyzing the data according to the type of sponsor, studies promoted by industry went from an average activation time of 195 days in the first project monitoring period to 122 days in the final one. In comparison, studies promoted by institutions went from an average activation time of 106 days in the period between November 2019 and February 2020 to 50 days in the period between May 2022 and August 2022 (Fig.  4 ).

Comparison of the average activation time of industry or institution promoted trials in the first and last monitoring period

At the DAIRI in the Piedmont Region (Italy), a project of the reorganization of the start-up phase led to a reduction from 218 to 56 days of the clinical trial activation process.

During the course of the project, an implementation and reorganization of the staff was also carried out. The turnover of staff involved in this process had a negative impact on the average timelines for the last quarter of 2020 and the first quarter of 2021. This critical issue was agilely overcome thanks to the expertise developed by the working group composed by healthcare (e.g., biologist, research coordinators and data mangers) and administrative staff, which enabled the new staff involved to be trained quickly. This can be observed because the average times monitored in the second quarter of 2021 decreased further compared to those in the second quarter of 2020.

The importance of having trained staff in these specific activities was also observed in another reorganization project [ 10 ].

Despite the fact that the project was conducted during the COVID-19 pandemic, we did not identify any factors related to this that may have positively or negatively influenced the average timing of the activation phase of the studies. The studies on this specific topic were not included in the project precisely to avoid a bias because the COVID-19 trials’ activation process was fast-tracked, given the emergency status, according to national legislation.

Active participation in the project to reorganize the clinical trials’ authorization process by all the staff of the three facilities involved enabled them to gain the ability to analyze any criticalities that arise along the way and, through discussion in scheduled meetings, to develop additional countermeasures to facilitate the process.

Among the countermeasures taken that led to the reduced timelines was the identification and training of a group of data managers who check the completeness and assess the suitability of documents before the EC meeting, maintaining contact with the sponsor, principal investigator, clinical research organization (CRO), and ECS. This reduced the number of documentation integration requests from the EC, making the ethics approval phase faster.

In a further move to streamline the EC approval process, ECS compiles a draft opinion before each EC meeting, and once the study is approved, the approval is digitally signed by the EC chair.

The most effective countermeasure applied was to no longer run a linear pathway but to run it in parallel across sectors, as found in similar reorganization projects [ 10 , 11 ]. According to the current process, the negotiation of the agreement begins in parallel with the evaluation conducted by the CTC, so that once the trial can be forwarded to the EC, the text of the agreement has already been finalized between the AO AL and the promoter (or its delegate). In addition, in order to simplify the agreement negotiation phase, the institution decided to adopt the draft agreement issued by the national authority in charge of drug studies (AIFA) and propose its use to sponsors and CROs.

Finally, in view of the fact that more and more sponsors are requesting digital signature of the agreement, it has been fully adopted, and the director general of the institute has delegated the signing of clinical trial agreements to the head of the AC.

A factor that influences the average timing of the activities carried out by the CTC is the parallel submission of interventional drug trials to the competent authority, coordinating ethics committee, and satellite ethics committee: according to regulations of the local ethics committee, it was not possible to release the approval until it was acquired the favorable approval issued by the coordinating EC. In the case of interventional drug trials, many times the documentation was taken over by the CTC, which carried out the scientific-technical evaluation but then could not proceed to submit the study to the EC.

This delay was eliminated with the full entry into force of the European Clinical Trials Regulation No. 536/14, which, for the activation of this specific type of study, removes the need to submit a trial to several ethics committees in the same country, requiring the approval of only one [ 6 ].

The time required to activate a trial is even longer for studies with agreement, because after approval by the institution, there are additional steps, which also depend on the rapidity of the sponsor’s response. This has also been highlighted at other centers that have conducted an analysis related to the management of the trial activation process [ 9 , 10 , 11 ].

Comparing the time reduction achieved with that found in other projects [ 12 ], it can be considered that the reorganization of the trial activation pathway was successful and that the pathway was fully standardized.

In conclusion, to the best of our knowledge, this is the first study to analyze and improve the clinical trial activation process in Italy, using the lean thinking methodology.

This study reported an analysis of the clinical trials’ activation pathway in a public hospital of Alessandria in northern Italy. Lean approach allowed a reduction from 218 to 56 days, from documentation intake to authorization act. The hospital includes a Research and Innovation Department characterized by a research infrastructure with facilities as centralized clinical trial center and administrative coordination equipped with dedicated and qualified clinical and administrative.

The reorganization of the complex regulative process led to the development of a standard operating procedure and a tool to monitor the KPIs of the clinical trial activation process that can also be implemented in other clinical centers.

Availability of data and materials

Raw data were generated at DAIRI. Derived data supporting the findings of this study are available from the corresponding author CP on request.

Abbreviations

Research and Innovation Department

Clinical trial center

Ethics committee secretariat

Administrative coordination

Key performance indicator

Italian Drug Agency

Public Hospital “SS Antonio e Biagio e Cesare Arrigo” of Alessandria

Ethic committee

Clinical Research Organization

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Carolina Pelazza, Marta Betti, Francesca Marengo & Antonio Maconi

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Pelazza, C., Betti, M., Marengo, F. et al. The clinical trial activation process: a case study of an Italian public hospital. Trials 25 , 240 (2024). https://doi.org/10.1186/s13063-024-08059-z

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Received : 12 July 2023

Accepted : 14 March 2024

Published : 05 April 2024

DOI : https://doi.org/10.1186/s13063-024-08059-z

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• Clinical trials’ activation
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