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Case Studies

What are case studies.

Case studies are stories or scenarios, often in narrative form, created and used as a tool for analysis and discussion. They have long been used in higher education, particularly in business and law. Hatcher et al. (2018, pp. 274-5) write:

Case studies, at their core, are metaphors for larger, more general classes of administrative problems. When presented to a class, they are narratives allow students to envision themselves in the role of the protagonist and experience the application of theory to practice by struggling with and attempting to solve the problem or issue that the protagonist faces.... Out of the metaphor students can derive a series of “lessons learned” that they can apply or transfer to other, more general issues that may arise in their professional careers.

They further note (p. 276) that "[a] good case is one that achieves its learning objectives by means of a story and a critical analysis of the situation".

Cases are often based on actual events, which adds a sense of urgency or reality. Case studies have elements of simulations , although for case studies the students tend to be observers rather than participants.

Why use case studies?

Case studies are effective ways to get students to practically apply their skills and their understanding of learned facts to a real-world situation. They are particularly useful where situations are complex and solutions are uncertain.

They can serve as the launching pad for a class discussion, or as a project for individuals or small groups. A single case may be presented to several groups, with each group offering its solutions.

Used as a teaching tool, a case study:

• engages students in research and reflective discussion
• encourages higher-order thinking
• facilitates creative problem solving
• allows students to develop realistic solutions to complex problems
• develops students' ability to identify and distinguish between critical and extraneous factors
• enables students to apply previously acquired skills
• creates an opportunity for students to learn from one another.

Case studies bridge the gap between a more teacher-centred lecture method and pure problem-based learning. They leave room for teachers to give direct guidance, and the scenarios themselves provide hints and parameters within which the students operate.

Common issues using case studies

The challenges with case studies are similar to those with discussions :

• getting students to talk and keeping the class moving
• pointless arguments, which can throw a case analysis off track.

Since case-study analysis is student-led, it can be difficult to get the class to move through various stages of analysis and arrive at a reasonable conclusion.

How to write or choose case studies

Hatcher et al. (2018, p. 276) categorise case studies as either issue-driven (focusing on a particular problem or aspects of the course material) or organisationally based (focusing on the various issues faced by a particular type of organisation). They can be based on general knowledge or adopt the viewpoint of a single protagonist, an organisation as a whole or information gathered from governent, company or other public documents.

"Like any good story" (Hatcher et al., 2018, p. 279), a case study begins with an exposition that introduces the problem and the protagonist and launches the action. Next, the narrative escalates, with complications exacerbating the problem and constraining the protagonist's choices. These complications are revealed as the protagonist discovers them, rather than as part of the background information, to increase the verisimilitude of the case study. Eventually the situation comes to a head, and the protagonist must decide on a solution. Finally, the case study relates the consequences of that solution.

A case study should be engaging, relevant and clearly written. In particular it needs to be economical: every aspect must be directly relevant to the problem the case study is examining, with no extraneous details or digressions.

How to teach effectively with case studies

Case content should reflect the purposes of the course, and should align with the course learning outcomes, other teaching strategies and assessment in your course or program.

1) Use complex cases requiring multiple perspectives

A good case has sufficient detail to:

• necessitate research and
• stimulate analysis from a variety of viewpoints or perspectives.

It places the learner in the position of problem-solver. Students actively engage with the materials, discovering underlying issues, dilemmas and conflict issues.

2) Assess the process of analysis, not only the outcome

The resolution of a case is only the last stage of a process. You can observe or evaluate:

• the quality of research
• structural issues in written material
• organisation of arguments
• the feasibility of solutions presented
• intra-group dynamics
• evidence of consideration of all case factors.

Case studies may be resolved in more than one manner.

3) Use a variety of questions in case analysis

Various ways to use questions in teaching are discussed in detail on the Questioning page. If you are using the Harvard Business School Case Method , when analysing case studies, use a range of question types to enable the class to move through the stages of analysis:

• clarification / information seeking ( what? )
• analysis / diagnosis ( why? )
• conclusion / recommendation ( what now? )
• implementation ( how? ) and
• application / reflection ( so what? what does it mean to you?)
• For help using media to create case studies, see Creative Development and Educational Media Production .
• UNSW Assessment Toolkit:  Assessment by Case Studies and Scenarios
• The HBS Case Method (Harvard Business School).
• What the Case Method Really Teaches
• How to write a teaching case study

Gwee, J. (2018). The case writer's toolkit. Palgrave Macmillan.

Hatcher, W., McDonald, B. D., & Brainard, L. A. (2018). How to write a case study for public affairs. Journal of Public Affairs Education , 24 (2), 274-285. https://doi.org/10.1080/15236803.2018.1444902

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A range of easy-to-use templates featuring UNSW’s refreshed brand are available from the ‘downloads’ section of the UNSW Brand Hub .

The templates, which have been available since February this year, include a new email signature, Microsoft Word and PowerPoint templates, and many more. 

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We are also in the process of developing more sophisticated PowerPoint and Word templates which will be made available in the next few months, so watch this space!  

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Discussion Activity 10 - Case Study or Personal Examples

Our final discussion is based on a case study

Please read the short case Managing Grace  https://hbsp.harvard.edu/tu/6dabaf06  and answer  one  the following questions. You should draw on concepts from unit 10 as well as any other relevant concepts in answering the questions.

Case: Managing Grace:  

1.       In order to effectively manage up what things should Grace understand about herself?

2.       What should she understand about Landon?

3.       Should Grace send that email to Bill? What would be the likely impact on Landon? On Grace?

4.       Imagine Grace has come to you for help. Develop a plan for her to manage her relationship with Landon in order to meet her own career goal

If you find that the questions on the case have been well addressed by the time you get to the forum (and this is often the case with case discussions) you can share some personal examples and address one of the following questions below:

Your boss is an important figure in your working life and you need the boss’s support: bosses can open doors and advocate for you and help you develop yourself. Symbiotically, your boss also needs your cooperation and engagement to achieve their objectives. Being able to effectively manage the reciprocal characteristics of this relationship with a manager is an important capability.

1.      Do you attempt to consciously manage your boss? Have you used any of the proposed six measures in  Reading 10.1  (compatible work styles, mutual expectations, information flow, dependability & honesty, good use of time and good use of resources) in managing your boss?

2.      How aware are you of your boss’s goals and objectives, pressures, strengths, weaknesses, blind spots, and preferred work style? How could you become more aware? How would becoming more aware of these factors change the dynamic of the relationship with your boss?

How to write a case study — examples, templates, and tools

It’s a marketer’s job to communicate the effectiveness of a product or service to potential and current customers to convince them to buy and keep business moving. One of the best methods for doing this is to share success stories that are relatable to prospects and customers based on their pain points, experiences, and overall needs.

That’s where case studies come in. Case studies are an essential part of a content marketing plan. These in-depth stories of customer experiences are some of the most effective at demonstrating the value of a product or service. Yet many marketers don’t use them, whether because of their regimented formats or the process of customer involvement and approval.

A case study is a powerful tool for showcasing your hard work and the success your customer achieved. But writing a great case study can be difficult if you’ve never done it before or if it’s been a while. This guide will show you how to write an effective case study and provide real-world examples and templates that will keep readers engaged and support your business.

In this article, you’ll learn:

What is a case study?

How to write a case study, case study templates, case study examples, case study tools.

A case study is the detailed story of a customer’s experience with a product or service that demonstrates their success and often includes measurable outcomes. Case studies are used in a range of fields and for various reasons, from business to academic research. They’re especially impactful in marketing as brands work to convince and convert consumers with relatable, real-world stories of actual customer experiences.

The best case studies tell the story of a customer’s success, including the steps they took, the results they achieved, and the support they received from a brand along the way. To write a great case study, you need to:

• Celebrate the customer and make them — not a product or service — the star of the story.
• Craft the story with specific audiences or target segments in mind so that the story of one customer will be viewed as relatable and actionable for another customer.
• Write copy that is easy to read and engaging so that readers will gain the insights and messages intended.
• Follow a standardized format that includes all of the essentials a potential customer would find interesting and useful.
• Support all of the claims for success made in the story with data in the forms of hard numbers and customer statements.

Case studies are a type of review but more in depth, aiming to show — rather than just tell — the positive experiences that customers have with a brand. Notably, 89% of consumers read reviews before deciding to buy, and 79% view case study content as part of their purchasing process. When it comes to B2B sales, 52% of buyers rank case studies as an important part of their evaluation process.

Telling a brand story through the experience of a tried-and-true customer matters. The story is relatable to potential new customers as they imagine themselves in the shoes of the company or individual featured in the case study. Showcasing previous customers can help new ones see themselves engaging with your brand in the ways that are most meaningful to them.

Besides sharing the perspective of another customer, case studies stand out from other content marketing forms because they are based on evidence. Whether pulling from client testimonials or data-driven results, case studies tend to have more impact on new business because the story contains information that is both objective (data) and subjective (customer experience) — and the brand doesn’t sound too self-promotional.

Case studies are unique in that there’s a fairly standardized format for telling a customer’s story. But that doesn’t mean there isn’t room for creativity. It’s all about making sure that teams are clear on the goals for the case study — along with strategies for supporting content and channels — and understanding how the story fits within the framework of the company’s overall marketing goals.

Here are the basic steps to writing a good case study.

1. Identify your goal

Start by defining exactly who your case study will be designed to help. Case studies are about specific instances where a company works with a customer to achieve a goal. Identify which customers are likely to have these goals, as well as other needs the story should cover to appeal to them.

The answer is often found in one of the buyer personas that have been constructed as part of your larger marketing strategy. This can include anything from new leads generated by the marketing team to long-term customers that are being pressed for cross-sell opportunities. In all of these cases, demonstrating value through a relatable customer success story can be part of the solution to conversion.

2. Choose your client or subject

Who you highlight matters. Case studies tie brands together that might otherwise not cross paths. A writer will want to ensure that the highlighted customer aligns with their own company’s brand identity and offerings. Look for a customer with positive name recognition who has had great success with a product or service and is willing to be an advocate.

The client should also match up with the identified target audience. Whichever company or individual is selected should be a reflection of other potential customers who can see themselves in similar circumstances, having the same problems and possible solutions.

Some of the most compelling case studies feature customers who:

• Switch from one product or service to another while naming competitors that missed the mark.
• Experience measurable results that are relatable to others in a specific industry.
• Represent well-known brands and recognizable names that are likely to compel action.
• Advocate for a product or service as a champion and are well-versed in its advantages.

Whoever or whatever customer is selected, marketers must ensure they have the permission of the company involved before getting started. Some brands have strict review and approval procedures for any official marketing or promotional materials that include their name. Acquiring those approvals in advance will prevent any miscommunication or wasted effort if there is an issue with their legal or compliance teams.

3. Conduct research and compile data

Substantiating the claims made in a case study — either by the marketing team or customers themselves — adds validity to the story. To do this, include data and feedback from the client that defines what success looks like. This can be anything from demonstrating return on investment (ROI) to a specific metric the customer was striving to improve. Case studies should prove how an outcome was achieved and show tangible results that indicate to the customer that your solution is the right one.

This step could also include customer interviews. Make sure that the people being interviewed are key stakeholders in the purchase decision or deployment and use of the product or service that is being highlighted. Content writers should work off a set list of questions prepared in advance. It can be helpful to share these with the interviewees beforehand so they have time to consider and craft their responses. One of the best interview tactics to keep in mind is to ask questions where yes and no are not natural answers. This way, your subject will provide more open-ended responses that produce more meaningful content.

4. Choose the right format

There are a number of different ways to format a case study. Depending on what you hope to achieve, one style will be better than another. However, there are some common elements to include, such as:

• An engaging headline
• A subject and customer introduction
• The unique challenge or challenges the customer faced
• The solution the customer used to solve the problem
• The results achieved
• Data and statistics to back up claims of success
• A strong call to action (CTA) to engage with the vendor

It’s also important to note that while case studies are traditionally written as stories, they don’t have to be in a written format. Some companies choose to get more creative with their case studies and produce multimedia content, depending on their audience and objectives. Case study formats can include traditional print stories, interactive web or social content, data-heavy infographics, professionally shot videos, podcasts, and more.

5. Write your case study

We’ll go into more detail later about how exactly to write a case study, including templates and examples. Generally speaking, though, there are a few things to keep in mind when writing your case study.

• Be clear and concise. Readers want to get to the point of the story quickly and easily, and they’ll be looking to see themselves reflected in the story right from the start.
• Provide a big picture. Always make sure to explain who the client is, their goals, and how they achieved success in a short introduction to engage the reader.
• Construct a clear narrative. Stick to the story from the perspective of the customer and what they needed to solve instead of just listing product features or benefits.
• Leverage graphics. Incorporating infographics, charts, and sidebars can be a more engaging and eye-catching way to share key statistics and data in readable ways.
• Offer the right amount of detail. Most case studies are one or two pages with clear sections that a reader can skim to find the information most important to them.
• Include data to support claims. Show real results — both facts and figures and customer quotes — to demonstrate credibility and prove the solution works.

6. Promote your story

Marketers have a number of options for distribution of a freshly minted case study. Many brands choose to publish case studies on their website and post them on social media. This can help support SEO and organic content strategies while also boosting company credibility and trust as visitors see that other businesses have used the product or service.

Marketers are always looking for quality content they can use for lead generation. Consider offering a case study as gated content behind a form on a landing page or as an offer in an email message. One great way to do this is to summarize the content and tease the full story available for download after the user takes an action.

Sales teams can also leverage case studies, so be sure they are aware that the assets exist once they’re published. Especially when it comes to larger B2B sales, companies often ask for examples of similar customer challenges that have been solved.

Now that you’ve learned a bit about case studies and what they should include, you may be wondering how to start creating great customer story content. Here are a couple of templates you can use to structure your case study.

Template 1 — Challenge-solution-result format

• Start with an engaging title. This should be fewer than 70 characters long for SEO best practices. One of the best ways to approach the title is to include the customer’s name and a hint at the challenge they overcame in the end.
• Create an introduction. Lead with an explanation as to who the customer is, the need they had, and the opportunity they found with a specific product or solution. Writers can also suggest the success the customer experienced with the solution they chose.
• Present the challenge. This should be several paragraphs long and explain the problem the customer faced and the issues they were trying to solve. Details should tie into the company’s products and services naturally. This section needs to be the most relatable to the reader so they can picture themselves in a similar situation.
• Share the solution. Explain which product or service offered was the ideal fit for the customer and why. Feel free to delve into their experience setting up, purchasing, and onboarding the solution.
• Explain the results. Demonstrate the impact of the solution they chose by backing up their positive experience with data. Fill in with customer quotes and tangible, measurable results that show the effect of their choice.
• Ask for action. Include a CTA at the end of the case study that invites readers to reach out for more information, try a demo, or learn more — to nurture them further in the marketing pipeline. What you ask of the reader should tie directly into the goals that were established for the case study in the first place.

Template 2 — Data-driven format

• Start with an engaging title. Be sure to include a statistic or data point in the first 70 characters. Again, it’s best to include the customer’s name as part of the title.
• Create an overview. Share the customer’s background and a short version of the challenge they faced. Present the reason a particular product or service was chosen, and feel free to include quotes from the customer about their selection process.
• Present data point 1. Isolate the first metric that the customer used to define success and explain how the product or solution helped to achieve this goal. Provide data points and quotes to substantiate the claim that success was achieved.
• Present data point 2. Isolate the second metric that the customer used to define success and explain what the product or solution did to achieve this goal. Provide data points and quotes to substantiate the claim that success was achieved.
• Present data point 3. Isolate the final metric that the customer used to define success and explain what the product or solution did to achieve this goal. Provide data points and quotes to substantiate the claim that success was achieved.
• Summarize the results. Reiterate the fact that the customer was able to achieve success thanks to a specific product or service. Include quotes and statements that reflect customer satisfaction and suggest they plan to continue using the solution.
• Ask for action. Include a CTA at the end of the case study that asks readers to reach out for more information, try a demo, or learn more — to further nurture them in the marketing pipeline. Again, remember that this is where marketers can look to convert their content into action with the customer.

While templates are helpful, seeing a case study in action can also be a great way to learn. Here are some examples of how Adobe customers have experienced success.

Juniper Networks

One example is the Adobe and Juniper Networks case study , which puts the reader in the customer’s shoes. The beginning of the story quickly orients the reader so that they know exactly who the article is about and what they were trying to achieve. Solutions are outlined in a way that shows Adobe Experience Manager is the best choice and a natural fit for the customer. Along the way, quotes from the client are incorporated to help add validity to the statements. The results in the case study are conveyed with clear evidence of scale and volume using tangible data.

The story of Lenovo’s journey with Adobe is one that spans years of planning, implementation, and rollout. The Lenovo case study does a great job of consolidating all of this into a relatable journey that other enterprise organizations can see themselves taking, despite the project size. This case study also features descriptive headers and compelling visual elements that engage the reader and strengthen the content.

Tata Consulting

When it comes to using data to show customer results, this case study does an excellent job of conveying details and numbers in an easy-to-digest manner. Bullet points at the start break up the content while also helping the reader understand exactly what the case study will be about. Tata Consulting used Adobe to deliver elevated, engaging content experiences for a large telecommunications client of its own — an objective that’s relatable for a lot of companies.

Case studies are a vital tool for any marketing team as they enable you to demonstrate the value of your company’s products and services to others. They help marketers do their job and add credibility to a brand trying to promote its solutions by using the experiences and stories of real customers.

When you’re ready to get started with a case study:

• Think about a few goals you’d like to accomplish with your content.
• Make a list of successful clients that would be strong candidates for a case study.
• Reach out to the client to get their approval and conduct an interview.
• Gather the data to present an engaging and effective customer story.

Adobe can help

There are several Adobe products that can help you craft compelling case studies. Adobe Experience Platform helps you collect data and deliver great customer experiences across every channel. Once you’ve created your case studies, Experience Platform will help you deliver the right information to the right customer at the right time for maximum impact.

To learn more, watch the Adobe Experience Platform story .

Keep in mind that the best case studies are backed by data. That’s where Adobe Real-Time Customer Data Platform and Adobe Analytics come into play. With Real-Time CDP, you can gather the data you need to build a great case study and target specific customers to deliver the content to the right audience at the perfect moment.

Watch the Real-Time CDP overview video to learn more.

Finally, Adobe Analytics turns real-time data into real-time insights. It helps your business collect and synthesize data from multiple platforms to make more informed decisions and create the best case study possible.

Request a demo to learn more about Adobe Analytics.

https://business.adobe.com/blog/perspectives/b2b-ecommerce-10-case-studies-inspire-you

https://business.adobe.com/blog/basics/business-case

https://business.adobe.com/blog/basics/what-is-real-time-analytics

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Sample Abstracts for Writing

These pages show two examples of typical abstracts from honours theses. Notice that the stages of the abstracts have been labelled, so that you can see the function of each sentence or part-sentence. You can also see that there are differences in the type of information that is included in each abstract, as well as differences in level of detail.

Sample 1: Genetic Mechanisms and Dissemination of Antibiotic Resistance

Abstract (Background statement)  The spread of antibiotic resistance is aided by mobile elements such as transposons and conjugative plasmids. ( Narrowing statement)  Recently, integrons have been recognised as genetic elements that have the capacity to contribute to the spread of resistance. ( Elaboration of narrowing) (statement)  Integrons constitute an efficient means of capturing gene cassettes and allow expression of encoded resistance. (Aims)  The aims of this study were to screen clinical isolates for integrons, characterise gene cassettes and extended spectrum b-lactamase (ESBL) genes.   (Extended aim)  Subsequent to this, genetic linkage between ESBL genes and gentamicin resistance was investigated.  (Results)  In this study, 41 % of multiple antibiotic resistant bacteria and 79 % of extended-spectrum b-lactamase producing organisms were found to carry either one or two integrons, as detected by PCR.   (Results)   A novel gene cassette contained within an integron was identified from Stenotrophomonas maltophilia, encoding a protein that belongs to the small multidrug resistance (SMR) family of transporters.  (Results)   pLJ1, a transferable plasmid that was present in 86 % of the extended-spectrum b-lactamase producing collection, was found to harbour an integron carrying aadB, a gene cassette for gentamicin, kanamycin and tobramycin resistance and a blaSHV-12 gene for third generation cephalosporin resistance.  (Justification of results)  The presence of this plasmid accounts for the gentamicin resistance phenotype that is often associated with organisms displaying an extended-spectrum b-lactamase phenotype. (Jones 2004, p.9)

Sample 2: Permeable Treatment Walls 

Abstract (Background statement)   A review of groundwater remediation in use today shows that new techniques are required that solve the problems of pump and treat, containment and in-situ treatment.   (Narrowing statement)  One such technique is the method that involves the use of permeable treatment walls.   (Elaboration)  These methods use a reactive medium such as iron to remediate contaminated groundwater.   (Aim*)  Several methods of implementing this remediation strategy have been described.   (Elaboration of aim)  These methods include injection and trenching.   (Specific focus of aim)  The use of a funnel and gate system via a trench has been examined in detail  (Methods)  using a groundwater modelling option of the FLAC program.   (Methods)  The modelling involved an analysis of the effect of changing the lengths of the walls and gate, varying the permeability, and varying the number of gates.   (Results)  The results showed that increasing the wall length, gate length and permeability increases the size of the plume captured.   (Key result)  An important factor in designing the walls is the residence time of the water in the gate or the contact time of the contaminant with the reactive media.   (Evaluation of results)  A sensitivity analysis has been conducted that shows that increasing the size of the capture zone decreases the residence time  (Limitations)  which will limit the design.   (Future applications and research)  The results of the modelling and sensitivity analysis are presented such that they can be used as an aid to the design of permeable treatment walls. (Dasey G. 1996 p.i) 

 *   This is the aim of the research, but it is not very clearly stated.  It might be better if the aim was made more explicit.

Sample 3: The Effects of Flouride on the Reproduction of Three Native Australian Plant Species

Note: This abstract is referred to as an Executive Summary (original 2 pages)

(Background statement)  No other form of environmental pollution has had as widespread detrimental effect on the growth and reproductive capacity of plants as air pollution.  (Narrowing statement)  Fluorides have long been recognized as highly toxic and research has shown that they are the most phytotoxic of all air pollutants.  (Elaboration of narrowing statement)  One of the most subtle impacts of fluoride on plant development is on their reproductive processes… There has been very little work directed towards forest trees, and especially native Australian species. (Broad purpose of study)  An understanding of the effects of fluoride on the reproductive processes of plant species within a forest community may help predict changes within the community following an increase in atmospheric fluoride arising from industrial sources. (Narrowing of purpose of study)  This study investigates the effects of increased atmospheric fluoride emissions from an aluminium smelter, on the reproductive processes of three native species, Banksia aemula, Bossiaea heterophylla and Actinotus helianthi. Elaboration of purpose Attention has also been paid to the soil seed reserve as an important resource for the replacement of adult plants within the community. (Results)  For Banksia aemula the study found that the reproduction of this fluoride-sensitive species may be affected in the close vicinity of the smelter… For the two ground layer species the study found that the fluoride may be affecting the Bossiaea heterophylla but having no discernible or very little effect on the Actinotus helianthi.** (Significance of results 1)  The implications of these results for the forest community are that sensitive native species such as the long-lived Banksia aemula and Bossiaea heterophylla will be removed from the plant community close to the smelter. This will reduce the resources they provide to the existing ecosystem but will, however, free more resources for the more resistant opportunist species such as Actinotus helianthi as well as the many introduced species.  (Significance of results 2)  The soil seed reserve study indicated that the seed reserve was very small in all areas. This would have several negative impacts on the natural regeneration of the area in the event of the closure of the smelter… (Future research)  Further research is recommended to assess the biochemical pathways for both the vegetative and reproductive processes and the mechanisms of the pollination of this important species… This may need to be repeated at certain intervals to monitor any further changes that may result from the higher fluoride emissions of the new expansion.

Exercise for sample 3

The abstract (executive summary) above has been summarised to focus on key stages. Some of the omitted text is reproduced below. Can you identify the stages?

• The effects of the fluoride for the forest species were assessed by measuring several reproductive and associated characteristics of the plants found within forest areas along a fluoride gradient. 

See answer:

This is the only sentence which outlines the Method of the study. It is the next sentence after the Elaboration of purpose.

• Bossiaea heterophylla shows more visible signs of fluoride stress close to the smelter. Insect damage to the Bossiaea heterophylla seed pods were observed in the background sites but not in the high fluoride sites indicating that the fluoride may be having an effect on the seed predators close to the smelter. 

This short text is part of the Results and follows on from the results section above.

• This study looked at the difference in visible structures associated with reproduction. Leaves of the Banksia aemula trees growing close to the smelter have accumulated large concentrations of foliar fluoride. Whether this is affecting the physiology and biochemical processes of the plan(which in turn may indirectly affect the reproduction potential of the plants) or the increased fluoride in the atmosphere is directly affecting the reproduction mechanisms is difficult to ascertain from this study.

This text is the first part of the concluding paragraph. The remainder of the paragraph discusses further research.

Engineering & science

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Scholarly Resources 4 Students | scite.ai 21 May 2024

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Clinical Trials Research Governance

This site outlines the clinical trial research governance requirements for UNSW staff, students and researchers. Feedback on the clinical trials research governance process can be submitted by email to c [email protected] or directly to the Director RECS, Dr Ted Rohr E:  [email protected] .

At UNSW Clinical Trials are defined as any research study that prospectively assign human participants or groups of humans to one or more health-related interventions (which may include placebo or other control) where the primary aim of the research is to evaluate the effect of the intervention on health outcomes.

The  Clinical Trial Decision Tool  can be used to assist researchers in determining whether research meets the UNSW definition of a clinical trial. 

The sponsor of a trial is the company, institution or organisation which takes responsibility for the initiation, management, and/or financing of a clinical trial.  The main types of clinical trial sponsors are:

• Commercial Sponsor
• Contract Research Organisation Sponsor
• Collaborative Research Group Investigator Initiated Sponsor

Clinical Trials where UNSW is responsible as sponsor

UNSWs role as clinical trial sponsor is not automatically confirmed. UNSW researchers and staff members must obtain written confirmation from the UNSW Sponsors Delegate before recruitment and data collection for a clinical trial commences. UNSW can assume the role of trial sponsor for clinical trials conducted within Australia that meet UNSWs criteria for trial sponsorship. A list of the criteria is specified on the Sponsor Related Responsibilities webpage .

It is recommended that the following is completed before a clinical trial is submitted to a Human Research Ethics Committee for ethical approval to avoid further amendment or modification requests:

• A UNSW Clinical Trial Protocol Templates is used to develop the trial protocol.

The draft Clinical Trial Protocol is submitted for review by the UNSW Sponsors Delegate before submitting it for review and approval by a Human Research Ethics Committee.

Utilising an unapproved therapeutic good or an approved therapeutic good outside of the approved indications or unapproved purpose requires a Clinical Trail Notification through the Therapeutic Goods Administration (TGA) portal. The  UNSW Clinical Trials Governance office manages the Therapeutic Goods Administration (TGA) Clinical Trial Notification (CTN) submission portal and the notification and submission requirements as outlined on the UNSW Submitting a Clinical Trial Notification to the TGA page . 

The sponsor of a trial must enter into a clinical trial research agreement (CTRA) with each site, documenting the obligations of each party with respect to the conduct of the trial and outlining any payments that will be made to the site.

Information on how to develop the clinical trial research agreement request requirements, clinical research agreement information, submission instructions and the time involved in the process can be found on the  Clinical Trial Research Agreement Request for Signature page .

Insurance policies for clinical trials are not automatically covered. Therefore, researchers are required to confirm cover with UNSW Insurance . In addition, the following documentation must be prepared and sent via email to [email protected] with [email protected] copied on the submission email:

• Clinical Trials Insurance Application .
• Clinical Trial Protocol (a draft protocol is acceptable if the trial is pending approval by an HREC)

UNSW Insurance will confirm insurance or seek further clarifications via return email. A copy of this confirmation (if [email protected] ) is not copied on the return email must be sent to [email protected] .

Confirmation of clinical trials insurance cover must be provided before the following:

• Recruitment or Data Collection Commences.
• Clinical Trial Research Agreements are signed.

Insurance cover confirmation does not need to be provided on multiple occasions or each time a site clinical trial research agreement is submitted for signing.

A clinical trial protocol provides the plan for the undertaking of a clinical trial. The ICH GCP-guided requirements for the development of a clinical trial protocol are outlined at this section. The following templates are provided for use:

• Clinical Trial Protocol Template [ Medical Device]
• Clinical Trial Protocol Template [Medical Product]
• Clinical Trial Protocol Template [Health Interventions]

If UNSW agrees to be the sponsor for an international clinical trial, it is a requirement that an overseas clinical trial protocol template must be used. It is recommended that the standard sections such as delegation of sponsor duties, safety monitoring reporting, protocol deviations, serious breach, data ownership and risk based monitoring are included or added as an addendum to the protocol. 

Clinical trials that require a clinical trial protocol

A clinical trial protocol that complies with the Good Clinical Practice Guideline is to be developed for:

• Clinical trials that involve an investigational therapeutic medical product, device or biological;
• Clinical trials that require notification via the Therapeutic Goods Administration or the relevant regulatory body within the country that the trial will be conducted in; and/or
• Clinical trials where the trial sponsor requires a protocol.

A protocol is not required but is recommended for:

• Clinical trials involving a medical product, device or biological being used for the intended purpose listed in their respective Australian Register of Therapeutic Goods Public Summary or as per its conditions of approval in the country that the trial is being conducted;
• Clinical trials that do not involve a medical product, device or biological; and/or
• Trials that do not require notification via the Therapeutic Goods Administration Clinical Trial Notification process or the relevant regulatory body within the country that the trial will be conducted in.

Clinical Trial Protocol requirements for trials where UNSW is to be the Sponsor

The contents of the clinical trial protocol must include all items included at section 6.1 of the Guideline for Good Clinical Practice E6(R2) . In particular, the following items must be included as distinct sections in the clinical trial protocol:

• The risks relating to the investigational medical product, device, biological, trial conduct, design and methods must be defined in the clinical trial protocol.

Protocol Deviations and Serious Breaches

• Protocol deviation and serious breach definitions, procedures for recording, reporting and developing corrective and preventative action plans must be documented in the clinical trial protocol and reflect the requirements outlined in the protocol deviations and serious breach section.

Safety Monitoring

• Safety monitoring definitions, procedures for recording, reporting, and assessing safety monitoring reports must be documented in the clinical trial protocol and reflect the requirements outlined in the safety monitoring section. 

Delegation of duties

The UNSW Clinical Trial Delegation Log  defines the trial responsibilities of the UNSW Sponsor’s Delegate, the Coordinating Principal Investigator(s), Site Principal Investigator(s) and any trial-related personnel that accompany the clinical trial protocol.

The delegation's log must specify that the responsibilities for the conduct, oversight and monitoring for the trial are delegated to the Coordinating Principal Investigator. 

The Coordinating Principal Investigator may delegate trial-related responsibilities to the approved Principal Investigator(s) or trial related personnel. All trial-related duties delegated by the Coordinating Principal Investigator or Principal Investigator(s) and/or trial related personnel are only to be delegated to those that are qualified by experience and training.

The delegations log must specify that the UNSW Sponsor’s Delegate is notified of:

• Protocol Deviation reports outlined in the UNSW Research Misconduct Procedure.
• Any serious breach of Good Clinical Practice, the clinical trial protocol, the clinical trial standard operating procedures, or the human ethics approval that is likely to affect to a significant degree the safety or rights of participants or the reliability and robustness of the data generated in the clinical trial.
• Suspected Unexpected Adverse Reactions (SUSAR) or Unanticipated Serious Adverse Device Effect (USADE) events
• Significant Safety Issues likely to (or have the potential to) affect to a significant degree the safety or rights of participants or the reliability and robustness of the data generated in the clinical trial
• Urgent Safety Measures implemented to remove or prevent a significant safety issue
• Safety Reports relating to the continuation, suspension, or discontinuation of the clinical trial for safety reasons as they arise.
• Participant complaints or concerns received in relation to the conduct of the research.
• Any significant modifications to the clinical trial that are likely to affect to a significant degree the safety or rights of participants or the reliability and robustness of the data generated in the clinical trial.
• Amendments to clinical trial research agreements or service level agreements.
• Revisions to regulatory requirements including correspondence with the Therapeutic Goods Administration, clinical trial registries or the FDA.
• Site authorisation, addition of new sites, closure of approved sites of changes to the site Principal Investigator that is responsible for a site.

Monitoring of compliance

• Procedures for monitoring compliance must be documented in the trial protocol.

A trial should be conducted in compliance with the clinical trial protocol that has received prior Human Research Ethics Committee and, where applicable, overseas Institutional Review Board approval or favourable opinion.

A Human Research Ethics Committee/Institutional Review Board must be selected to complete an ethical review of the clinical trial. If the research requires the recruitment of participants from private institutions, public hospitals or sites in other countries, multiple HRECs or IRBs may need to be identified to review and approve a clinical trial. Trials conducted in Australia where UNSW is the sponsor must be reviewed and approved by an Australian Human Research Ethics Committee formally registered with NHMRC.

Specific details identifying the reviewing/approving HRECs/IRBs and the sites covered by the ethics approval must be included in the clinical trial protocol.

Approvals established with an NHMRC-recognised HREC outside of UNSW must be submitted for noting via the UNSW external ethics approval process . Clinical trials conducted overseas require UNSW HREC approval before a submission is made to the in-country IRB or equivalent.

ICH Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.

Clinical Trials Involving Investigational Therapeutic Goods

The therapeutic goods legislation requires that the use of investigational therapeutic medical products or devices in a clinical trial conducted under the CTN/CTX schemes are designed, conducted and monitored in accordance with the Guidelines for Good Clinical Practice (E6, R2 ), the Australian National Statement on Ethical Conduct in Human Research , and the clinical trial protocol as approved by the reviewing Human Research Ethics Committee (or Institutional Review Board as known in the US and other countries).

It is the responsibility of the Coordinating and Principal Investigators to ensure that all investigators and trial-related staff have current ICH Good Clinical Practice Training. Certificates of training completion need to be stored as an GCP essential document. According to ICH GCP, clinical trial staff are required to update their GCP training at least once every 3 years.

It is the responsibility of the Coordinating and Principal Investigators to familiarise themselves with the requirements of the  Guideline for Good Clinical Practice (E6, R2) .  

Other Clinical Trials

It is recommended that the requirements of GCP are met for all other trials involving human participants outside the strict definition of a clinical trial per se . The recommendation refers to researchers' recognition that best practice leads to good research outcomes.

Documenting GCP Training

Records of Good Clinical Practice Certificates from an accredited training authority must be documented for all investigators and personnel conducting clinical trial activities. Therefore, it is the responsibility of the Coordinating Principal Investigator to retain records of Good Clinical Practice certification and make them available to the UNSW Sponsors Delegate if requested.

The Investigator's Brochure (IB) is a compilation of the clinical and nonclinical data of the investigational product(s) that are relevant to the study of the product(s) in human subjects. Its purpose is to provide investigators and others involved in the trial with the information to facilitate their understanding of the rationale for, and their compliance with key features of the protocol, such as the dose, dose frequency/interval, methods of administration and safety monitoring procedures.

Clinical trials that require an investigator brochure

An investigator brochure that complies with the Good Clinical Practice Guideline must be developed for:

• Clinical trials that involve an investigational medical product, device or biological where this information has not been included in the clinical trial protocol.
• Clinical trials that require notification via the Therapeutic Goods Administration or the relevant regulatory body within the country that the trial will be conducted in.
• Clinical trials where the trial sponsor requires an investigator brochure.

Clinical trials that do not require an investigator brochure

An investigator brochure is not required but can be submitted for:

• Clinical trials involving a medical product, device or biological being used for the intended purpose listed in their respective Australian Register of Therapeutic Goods Public Summary or as per its conditions of approval in the country that the trial is being conducted.
• Clinical trials that do not involve a medical product, device or biological.
• Trials do not require notification via the Therapeutic Goods Administration Clinical Trial Notification process or the relevant regulatory body within the country that the trial will be conducted in.

The sponsor is responsible for developing procedures for identifying, assessing, and selecting the site(s), institution(s) and investigator(s) that are to participate in the clinical trial.

For trials sponsored by UNSW, the Coordinating Principal Investigator will be responsible for selection of trial sites, site principal investigator(s) and for the completion of feasibility activities.

The Coordinating Principal Investigator must ensure that the following is in place for each participating site:

Site Principal Investigator

• The Principal Investigator is qualified by experience and training to provide oversight and conduct the clinical trial at the site.
• The Principal Investigator has expertise with the target population and disease area being studied.
• The Principal Investigator has or is to be provided with protocol specific training and is aware of the requirement to conduct the trial in accordance with the protocol, HREC approved procedures and GCP.

Institution

• The institution responsible for the site has research governance. procedures in place for authorising the commencement of a clinical trial.
• The institution responsible for the site has adequate facilities, resources, technology, and qualified personnel to conduct the trial in accordance with the protocol, HREC approval and where applicable GCP.  
• The institution has procedures in place for facilitating the review of clinical trial research agreements, service agreements, insurance and indemnity requirements.
• The institution responsible for the site has procedures in place for responding to participant complaints, allegations of research misconduct and/or serious breaches of GCP.
• The site has access to the target population to meet recruitment targets.

Site Personnel

• All site personnel responsible for conducting the clinical trial in accordance with the protocol are qualified by experience and training.
• Copies of CVs, Good Clinical Practice training certificates and records of qualifications to demonstrate experience by qualification and training are obtained and documented.  

The Coordinating Principal Investigator must register the clinical trial on a publicly accessible register complying with international standards before the recruitment of the first participant. Below are the recommended platforms to register clinical trials.  

• International Clinical Trials Registry Platform
• Australian New Zealand Clinical Trials Registry.
• ISRCTN Registry

Information to assist with classifying the risk profile of clinical trials and the monitoring requirements can be accessed on the following webpage:

• https://research.unsw.edu.au/risk-based-management-and-monitoring-clinical-trials

This section outlines the requirements and definitions for safety reporting. 

Safety Monitoring Reporting

Adverse Event (AE), Adverse Device Effect (ADE), Adverse Reaction (AR), Serious Adverse Event (SAE)/Serious Adverse Reaction (SAR), Serious Adverse Device Effect (SADE), Suspected Unexpected Serious Adverse Reaction (SUSAR), Unanticipated Serious Adverse Device Effect (USADE), Significant Safety Issue (SSI) and Urgent Safety Measure (USM) are to be reported by the principal site investigator to the Sponsor. If UNSW is the Sponsor, the site principal investigator report must be sent to the Coordinating Principal Investigator. 

Safety Monitoring Report Form

A form used to report events must be designed for the trial. Paper-based versions or electronic versions can be developed. The forms should include a mechanism for assessment of seriousness, causality, and expectedness to be made.

Assessment and Management of Safety Monitoring Reports

Once a report has been made, procedures for assessing and classifying reports following the safety reporting assessment flowchart must be developed and documented in the protocol before recruitment and data collection starts. If UNSW is the Sponsor, the Coordinating Principal Investigator must develop the following procedures to meet these requirements.

Adverse Event Report Assessments

Event report forms classified the safety monitoring event as "not serious" must be assessed by a Qualified Physician named in the clinical trial protocol. The Qualified Physician must use the Safety Reporting Assessment Flowchart to determine whether the event is an adverse reaction or an adverse event. The Qualified Physician cannot delegate this responsibility to other research personnel. Please note that non IMD/IMP Clinical Trials do not require a Qualified Medical Physician to provide oversight over the trial however adverse events should be reviewed by Trial Monitoring Group that should consist of a physician. The reporting timeframes for adverse event reports from participating sites to the Coordinating Principal Investigator must be specified in the protocol. All adverse event reports must be recorded in the safety monitoring register.

Definition of a Qualified Physician/Medical Expert: A medical expert or clinician that is a listed investigator who has experienced by qualification and training in the research area that provides safety oversight, such as the ongoing monitoring of reports of adverse events (AEs) submitted by investigational sites to identify safety concerns. The Qualified Physician/Medical Expert cannot be a Principal Investigator responsible for a trial site. The name of this person must be specified in the general information section of the protocol. The role cannot be delegated to another party.

Serious Event Report Assessments

The Sponsor's Medical Expert must assess event report forms that classify the event as "serious". Therefore, a report must be sent to the Sponsor's Medical Expert for assessment as soon as possible and within seven working days of receiving the report form. The following criteria classify the report as serious:

• Life-threatening illness or injury (actual risk of death at the time of the event)
• Permanent impairment of body structure or body function
• In-patient or prolonged hospitalisation (not for a pre-existing condition or an elective surgery)
• Medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or function
• Led to fetal distress, fetal death or congenital abnormality or birth defect.

The Sponsor's Independent Medical Expert must use the Safety Reporting Assessment Flowchart to determine whether the event is a serious adverse reaction, a serious adverse event, or a serious adverse device effect.

The Sponsor's Independent Medical Expert cannot delegate this responsibility to other research personnel. Therefore, all decisions made by the Sponsor's Medical Expert are to be recorded.

Sponsor's Independent Medical Expert

A person who is independent of the listed investigators that is a qualified medical physician or clinician who is qualified by experience and training in the research area that provides safety oversight, such as the ongoing monitoring of reports of serious adverse events (SAEs) submitted by investigational sites to identify safety concerns and make recommendations for continuing or stopping a trial.

Serious Adverse Reaction (SAR) or Serious Adverse Device Effect (SADE)

Any serious adverse events related to the investigational medical product or device that occur and are referenced in the clinical trial protocol, the product information, referenced safety information or the investigator brochure must be classified by the Sponsor’s Independent Medical Expert as a SAR or a SADE.

Suspected Unexpected Adverse Reaction (SUSAR) or Unanticipated Serious Adverse Device Effect (USADE)

Any serious adverse events related to the investigational medical product or device that occur and are not referenced in the clinical trial protocol, the product information or investigator brochure must be classified by the Sponsors Independent Medical Expert as a SUSAR or USADE.

Register of Clinical Trial Safety Monitoring Reports

A register of all event reports made and assessed is to be kept by the Sponsor. If UNSW is the Sponsor, the Coordinating Principal Investigator (or delegated staff member as reflected in the trial delegation log) must maintain a register of safety monitoring events.

Reporting of Clinical Trial Safety Monitoring Reports

For trials where UNSW is the Sponsor, single case reports of Adverse Events (AEs), Adverse Reactions (AR), Adverse Device Effect, Serious Adverse Events (SAEs) Serious Adverse Reactions (SARs), Serious Adverse Device Effects (SADEs) reports do not need to be reported to the UNSW Sponsor's Delegate. However, all single case reports must be recorded in a safety monitoring register and need to be reported to the UNSW Sponsor's Delegate annually. The  UNSW Safety Monitoring Register Template UNSW  is provided as an example of the information to be recorded in a register. 

The Trial Management Group (TMG), Trial Safety Committee (TSC) or the Data Safety Monitoring Board (DSMB) must review the safety information to identify any serious emerging safety concerns. If safety concerns are identified, a plan to minimise the time participants may be placed at excess risk of harm must be developed. If no emerging safety issues are identified, the TMG must provide a safety review summary at least annually to the Clinical Trial Governance Office. In addition, the following must be reported to the UNSW Sponsor's Delegate via email to   [email protected] :

• A brief analysis of the safety profile of the trial intervention(s) and its implications for participants considering all available safety data and the results of relevant clinical or non-clinical studies (annually).
• A brief discussion of the implications of the safety data to the trial's risk-benefit ratio
• A description of any measures taken or proposed to minimise risks. (annually).
• Copies all safety review summaries along with the line listings that relate to these summaries.
• A report of emerging safety issues or where no safety issues have been identified documented evidence (e.g., minutes of a meeting) confirming that a review was undertaken.
• Plan to minimise the time participants are placed at excess risk due to emerging safety issues (within seven days of becoming aware of the safety issues).

Reporting of Suspected Unexpected Adverse Reactions (SUSAR)

Any clinical trial safety monitoring reports classified by the Sponsor's Medical Expert as a SUSAR must be reported to the Coordinating Principal Investigator.

The Coordinating Principal Investigator must report to the TGA and the UNSW Sponsor's Delegate:

• Any fatal or life-threatening Australian SUSARs or USADEs immediately, but no later than seven calendar days after being made aware of the case, with any follow up information within a further eight calendar days.
• All other Australian SUSARs or USADEs, no later than 15 calendar days after being made aware of the case.

Significant Safety Issues (SSIs)

Significant safety issues are defined as any safety issue that could adversely affect participants' safety or materially impact the continued ethical acceptability or conduct of the trial. In addition, the following steps must be followed in situations where urgent measures are taken to eliminate an immediate hazard to a participant's health or safety.

Principal Investigators must report significant safety issues must be reported immediately to the UNSW Sponsor’s Delegate. The report must be supported by advice from the principal Investigator addressing the following points:

• A description of the significant safety issue and any urgent safety measure implemented.
• A description of measures taken and advice on whether a temporary halt of the trial is required for safety reasons.
• An amendment of the clinical trial protocol needs to be submitted to the approving HREC.

Reporting of Significant Safety Issues (SSIs) and Urgent Safety Measures

The Principal Investigator is to report any significant safety issues/urgent safety measures to the Institution within 72 hours of becoming aware of the event. The UNSW Sponsor’s Delegate will then ensure that the significant safety issue is reported to the TGA, HREC and investigators within 15 calendar days of the sponsor instigating or being aware of the issue. For Urgent Safety Measures the Sponsor’s Delegate will notify the TGA, HREC and investigators within 72 hours.

This section outlines the safety monitoring requirements for clinical trials that do not involve an investigational medical product or device.

Safety event reports are to be reported by the principal site investigator to the sponsor. If UNSW is the sponsor, the Coordinating Principal Investigator must develop the following procedures to meet these requirements. If the trial does not have any participating sites, a process for recording and documenting adverse events and incidents is to be detailed as a procedure or within the HREC approved application.

Adverse Event: An adverse event is defined as any untoward occurrence (medical or other) in a clinical trial participant administered one or more of the trial interventions. All expected or known discomforts, harms, or effects that will be (or have the potential to be) induced by the trial procedures must be specified in the Human Ethics Application or a separate safety monitoring procedure. The safety information must also include:

• Measures for minimising the risk of a participant experiencing an event
• A plan for providing support of care for participants that experience an event.

Serious adverse event:  A serious adverse event is any event that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect. The clinical trial protocol must outline the research team's process to assess whether the event was related to the clinical trial, its procedures, or the interventions.

Significant Safety Issue:   Defined as an issue that could adversely affect participants' safety or materially impact the continued ethical acceptability or conduct of the trial. The human ethics application of safety monitoring procedure must specify that significant safety issues that occur are reported to the UNSW Sponsors Delegate immediately but no later than seven days.

Urgent Safety Measure:  Defined as a measure required to be taken to eliminate an immediate hazard to a participant's health or safety. The human ethics application of safety monitoring procedure must specify that urgent safety measures that occur are reported to the UNSW Sponsors Delegate immediately but no later than seven days.

For multi-centre trials, sites can use a form to report events that must be designed for the trial. Paper-based versions or electronic versions can be developed. Trials that do not have participating sites can record events in a safety monitoring register.

A register of all event reports made and assessed is to be kept by the sponsor. For example, if UNSW is the sponsor, the Coordinating Principal Investigator must maintain a register of safety monitoring events. The  UNSW Safety Monitoring Register Template UNSW  is provided as an example of the information to be recorded in a register.

Assessment of Safety Monitoring Reports

A group or committee must be established to assess safety monitoring reports. The group or committee must include at least one person qualified by experience and training who can provide an independent assessment of serious adverse events, significant safety issues, and urgent safety measures.

Adverse event reports can be assessed by an investigator listed in the ethics application that is experienced by qualification and training. The investigator must be independent of the site where the event occurred.

Reporting of Safety Monitoring Reports

Adverse Events and Serious Adverse Events:  For trials where UNSW is the sponsor, single case reports of Adverse Events and Serious Adverse Events do not need to be reported to the UNSW Sponsor's Delegate or the HREC. All case reports must be recorded in a safety monitoring register supported by an assessment of trial safety must be reported to the UNSW Sponsor's Delegate annually.

Significant Safety Issues:  Are to be reported immediately, but no later than seven days via email to  [email protected] .

Urgent Safety Measures:  Are to be reported immediately, but no later than seven days via email to  [email protected] .

We are working on procedures to provide meaningful intersections between possible non-compliance with Good Clinical Practice, the protocols approved in the relevant HREC approvals, and definitions of breaches as defined in the Australian Code for the Responsible Conduct of Research.

Protocol Deviation 

A protocol deviation is defined as any breach, divergence or departure from the requirements of Good Clinical Practice, the clinical trial protocol, the clinical trial standard operating procedures, or the human ethics approval and does not have a significant impact on the continued safety or rights of participants or the reliability and robustness of the data generated in the research or clinical trial. Protocol deviations are events that do not occur in a persistent or systematic manner, and do not have the potential to result in participant harms. Examples of protocol deviations include but are not limited to: 

• Deviations because of participant adherence to the protocol, including rescheduled study visits, participants refusal to complete scheduled research activities or failure to complete self-report questionnaires required by the study protocol.  
• Blood samples obtained or clinical trial testing occurring at times close to, but not precisely at the time points specified in the protocol. 
• The completion of consent forms, safety monitoring report, case report forms or data collection tools in a manner that is not consistent with the protocol instructions, or failure to make reports within the required reporting timeframes.  
• Administration of the clinical trial investigational medical product, or device in a manner that is not consistent with the manufacturer’s instructions for use. 
• Use of an unapproved version of the participant information statement or recruitment of participants using unapproved recruitment procedures.  
• Inclusion of a participant that does not meet the inclusion criteria.  
• An urgent safety measure implemented required to be taken to eliminate an immediate hazard to a participant’s health or safety. 

 Serious Breach  

A serious breach is defined as a breach of Good Clinical Practice, the clinical trial protocol, the clinical trial standard operating procedures, or the human ethics approval that is likely to affect to a significant degree the safety or rights of participants or the reliability and robustness of the data generated in the clinical trial. Examples of serious breaches include but are not limited to: 

• Persistent or systematic non-compliance with the instructions for completing consent forms, safety monitoring forms, case report forms or data collection tools that results in continued missed or incomplete data collection.  
• Failure to record or report adverse events, serious adverse events, suspected unexpected serious adverse reactions, significant safety issues where urgent safety measures were implemented.  
• Failure to conduct clinical trial procedures in accordance with the clinical trial delegation log.  
• Widespread and uncontrolled use of protocol waivers affecting eligibility criteria, which leads to harm to trial subjects. 
• Failure to report investigational medical product or device defects to the clinical trial sponsor or any relevant regulatory body. 
• Failure to conduct research in conformity with the issued approvals, permits or licences in accordance with required laws, regulations, disciplinary standards and UNSW policies relating to the responsible and/or safe conduct of research. 
• Concealing or facilitating breaches (or potential breaches) of the Research Code by others. 
• Conducting research without the requisite approvals, permits or licences required by laws, regulations, disciplinary standards and UNSW policies related to the responsible and/or safe conduct of research. 
• Failure to conduct Research as approved by an ethics review body where that conduct leads to (or has the potential to) results in participant harms. 
• Conducting Research without ethics approval as required by the National Statement on Ethical Conduct in Human Research where that conduct leads to (or has the potential to) result in participant harms. 
• Any breaches as outlined in the UNSW Research Misconduct Procedure or the Australian Code for responsible conduct of research that leads to (or has the potential to) result in participant harms.  

  Reporting Protocol Deviations   

Protocol deviations occurring at a site must be documented in site files and need to be reported by site principal investigator to the Coordinating Principal Investigator.

The Coordinating Principal Investigator must review the protocol deviation, along with the clinical trial protocol to establish the corrective actions and preventative steps to prevent the deviation from reoccurring. 

The protocol deviation and corrective action plan must be reported to the UNSW Sponsor’s Delegate by the Coordinating Principal Investigator or Coordinating Research Team using the protocol deviation report form.  

Reporting of a Serious Breach 

A serious breach occurring at a participating site must be reported by the site Principal Investigator to the Coordinating Principal Investigator within a specified timeframe.  

The Coordinating Principal Investigator must review the serious breach, along with the clinical trial protocol to develop a Corrective and Preventive Action (CAPA) that defines the steps to prevent the serious breach from reoccurring. 

The serious breach report and the CAPA is to be provided to the approving HREC and the UNSW sponsors delegate for review and approval.  

Reporting of Serious Breaches by Third Parties 

A Suspected Breach is a report that is judged by the reporter as a possible serious breach but has yet to be formally confirmed as a serious breach by the sponsor. 

A Suspected Breach form must be completed when a third party (e.g. individual / institution) wishes to report a suspected breach of Good Clinical Practice or the protocol. This should be reported directly to the reviewing HREC without reporting through the sponsor. 

Recording of Protocol Deviation and Serious Breach Reports  

A register of protocol deviation and serious breach reports must be recorded, written records and copies of documentation sent to the sponsor in the must be retained by in the Investigator Site File.  

Copies of protocol deviation and serious breach reports must be recorded, written records and copies of documentation sent to the sponsor, referrals made to the HREC or to establish whether a breach of the Australian Code for Responsible conduct of research  must be retained in the Master Site File.  

 Review of a Protocol Deviation and a Serious Breach 

The UNSW Sponsor’s Delegate will review reports to establish whether the event meets the definition of a protocol deviation or serious breach, to establish whether the proposed CAPA is appropriate and to establish whether there is or will be an ongoing impact on the reliability and robustness of the data generated. 

Advice from the approving HREC will be sought by the UNSW Sponsor’s Delegate on the corrective and preventive actions.

Protocol deviation and/or serious breach reports where a UNSW researcher, staff or student is responsible for the protocol deviation or the serious breach will be reviewed as per the  UNSW Research Misconduct Procedure  to establish whether a breach of the  UNSW Research Code of Conduct  has occurred. 

Protocol deviation and/or serious breach reports where the UNSW Sponsor’s Delegate determines that the site Principal Investigator(s)/ site personnel are responsible for a protocol deviation or the serious breach will be referred onto their responsible institution for review under their own Research Misconduct procedures to establish whether a breach of the  Australian Research Code for the Responsible Conduct of Research  has occurred.

Site Authorisation from the responsible institution is to be obtained before recruitment and data collection commences at a site. 

The Coordinating Principal Investigator is responsible for ensuring that the following documentation is in place before recruitment and data collection at a trial site commences:

• A letter from a person with the delegated authority for the institution responsible for the participating trial site that authorises the commencement of the trial.
• A clinical trial research agreement signed by the trial sponsor and the delegated authority for the site.
• CVs for all site investigators, and certificates of completed GCP training for all investigators and trial site personnel.
• Evidence to confirm that protocol specific training for investigators and site personnel has occurred.
• Evidence to confirm that site principal investigators and trial site staff have been made aware of the requirement to maintain adequate and accurate source documents and trial records that include all pertinent observations on each of the site’s trial subjects. Source data should be attributable, legible, contemporaneous, original, accurate, and complete. Changes to source data should be traceable, should not obscure the original entry, and should be explained if necessary (e.g., via an audit trail)
• Evidence to confirm that the site Principal Investigator is aware of all documents to be retained in the Investigator Site File.
• Evidence to confirm that the current HREC approved documentation has been provided to the site.
• Any conflict of interest disclosures has been completed and documented.

UNSW Sydney NSW 2052 Australia Telephone +61 2 93851000 Authorised by Deputy Vice-Chancellor (Research) UNSW CRICOS Provider Code: 00098G ABN: 57 195 873 179

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Resume Checker

Resume Checker is an online tool that provides AI-based feedback on your resume, allowing you to create a new or update an existing resume.

Resume Checker enables you to:

• Get an objective score on your resume based on recruiter criteria.
• Improve the score by making edits based on targeted recommendations on aspects like Presentation, Language, and Skills.
• Obtain targeted suggestions for various bullets on the resume.

You can upload your resume ten times (per academic year) to access feedback and example suggestions for improving your resume.

Use Resume Checker to create your resume draft before booking a one-on-one Career Advice Appointment with a Career Coach, to get more out of the consultation!

Resume Checker is provided for free for UNSW current students by UNSW Careers.

Use our resources or attend a seminar on Writing an Effective Resume and Cover Letter to get started on your first resume or if it's been a while between resume updates.

Log onto the Resume Checker using your zID and password. When prompted, choose your Faculty. If you are completing a double degree, choose the Faculty that aligns with your future career.

Upload your resume in PDF format to VMock. You will receive instant feedback across 3 sections ~ Impact, Presentation, and Competencies. Leverage the SMART Edit functionality within the system feedback page to auto-convert your resume to the UNSW template. Continue to make the required edits and follow instructions to enhance your bullets. Once ready, hit the Re-Score button. Alternatively, you may leverage the ‘Create New’ functionality in case you don’t have an existing draft of your resume using SMART Editor.

Book a one-on-one Career Coaching Session with a Career Coach to take your resume to the next level and further tailor your resume for specific industries, jobs, and opportunities.

Frequently asked questions

Choose the Faculty that best aligns with your future career.

Yes, you can upload any PDF version of your resume, however, if you have not followed the recommended UNSW template the system may not recognise that you have all of the information in your resume. This means the overall score given to your resume will be low even if you have the right information included. You can still use the feedback to improve the content of your resume. Alternatively, you can create a new resume from scratch on VMock platform using SMART Editor.

Not at this stage. It is best to have the Resume Checker platform and your resume open at the same time to switch between the two documents to incorporate the feedback.

Yes, you can edit your resume on Resume Checker using SMART Editor module. Go to Detailed Feedback > SMART Edit.

Green = a score above 85 which means you have included many of the key elements.

Yellow = a score between 31and 85, which means you are missing many of the key elements.

Red = a score below 30 means that you have a lot of elements missing from your resume and will need to incorporate the feedback to improve your score and overall resume.

X = mandatory section – you can increase the overall score of your resume by making sure you complete all mandatory sections

! = optional section – include these items if relevant

✓ = complete – you have done a good job in these sections

Presentation is an important component of your resume and you want to make sure you are putting your best foot forward and communicating in a professional manner.

Careers and Employment recommend that you follow the suggested date format, however, if you have a good reason for using another format, that is OK as long as you are consistent throughout your document. If you keep your original date formatting, your overall score will be reduced.

Filler words are words that the system has identified as unnecessary and can potentially be removed for a more succinct document. This feedback can be reviewed with a Career Coach in your appointment. 

Avoided words are words that the system has identified as unnecessary and can potentially be removed for a more succinct document. This feedback can be reviewed with a Career Coach in your appointment. 

No, you can say “Available upon request”, but you do need to use the title “Referees” (don’t forget the “s”).

No, it doesn’t. You should complete your grammar check outside of the system. The Learning & Career Hub is also a good place of support with excellent resources to help improve your grammar.

To maintain privacy, you can remove your name, phone and email address from your resume before uploading to Resume Checker.

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15 Best Case Study Templates to Use in Word and ClickUp

Praburam Srinivasan

Growth Marketing Manager

February 14, 2024

Case studies are valuable tools for sharing customer success stories and analyzing problem-solving approaches in a structured and informative manner. They can be used to provide detailed insights into specific projects, strategies, or challenges and offer valuable lessons and best practices for professionals across various fields. 

Content marketing teams often create case studies as a way to gain more customers and get new business. Case studies can give potential customers a better understanding of your company brand , what it does and how you could potentially help them. 

However, creating a compelling case study from scratch can be a time-consuming task. That’s where marketing case study examples and templates can help. 

What is a Case Study Template?

What makes a good case study template, 1. clickup case study template, 2. clickup case study design template, 3. clickup research report template, 4. clickup market research template, 5. clickup user research plan template, 6. clickup data analysis findings template, 7. clickup campaign report template, 8. clickup research whiteboard, 9. google docs case study template by wordstream, 10. word case study report template by template.net, 11. word case brief summary template by template.net, 12. word case study report template by template.net, 13. word case study research template by template.net, 14. word psychology case study template by template.net, 15. word media case study template by template.net.

A case study template is a pre-designed framework that serves as a starting point for creating comprehensive and structured case study documents. It provides a standardized, traditional case study format for organizing and presenting information about a particular project, problem-solving scenario, success story, or real-life situation.

Case study templates typically include sections for outlining the background and context of the case study, project documentation , describing the methodology or approach used, presenting data and analysis, and highlighting key findings and recommendations that tell the entire story. 

Business case study examples like templates can work as a guide to help content marketers, blog post writers, and anyone else creating quality content that’s customer-facing, focus on important aspects and maintain a logical flow while telling a compelling story.

Some key elements that make a case study template stand out include:

• Clarity and organization: A well-designed template should be easy to navigate. Each section should be labeled appropriately, enabling readers to quickly find the information they seek
• Flexibility: A good case study template should be easily customizable and able to accommodate diverse scenarios. It should be adaptable to different industries, research methodologies, and presentation styles
• Visual appeal: Incorporating visual elements like charts, graphs, and other images can enhance a case study template’s look and make it more visually appealing. They can also aid in the comprehension of complex data. A visually engaging template can captivate readers and make the case study more impactful

15 Case Study Templates to Use in 2024

You don’t have to start from scratch when making your next case study. Instead, take a look at these carefully curated case study templates from ClickUp and Microsoft Word.

ClickUp’s Case Study Template can provide a great start for just about any type of case study you and your team want to write. It kicks off with a section for introducing both your business and the client or customer that the case study focuses on. 

After introducing both yourself and the customer, you briefly highlight the customer’s experience and the successes you achieved before delivering a more detailed description of the work you performed and the measurable results you achieved. 

The next section focuses on the objective of the case study—what the client’s goal and pain point was and why they decided you were the right company to help them achieve these goals. 

The case study template then launches into a section describing the solutions you presented and the data that backs up your success. We created this marketing case study template for a marketing agency that helps customers achieve growth through paid media campaigns, but it can easily be edited to highlight any type of solution.

One of the best ways of telling a customer story using a case study is by allowing the customer to do most of the work themselves. When a case study is written by current or even previous customers, it feels more sincere and honest, especially to potential customers in the evaluation process. 

If you want to try this technique out, use this ClickUp Study Design Template . You can send your customer this great case study template and allow them to fill it out themselves and basically write a case study for you. This gives you unfiltered and unbiased answers to the questions you want answered in the case study. 

The case study template helps them understand what you want the case study to look like and how the customer’s story should be described. It also helps you get great customer quotes. 

A template makes it easier for your customer to frame their experiences with you and easily explain how your product or service helped them. Hearing a peer’s success story from a firsthand perspective can be a more convincing read for prospective customers. 

Manage customers with customer database software !

Case studies are essentially customer stories, which can be told in many ways and come in many formats. A research report is another excellent way to frame a case study. 

This ClickUp Research Report Template is a step-by-step guide that can help your team create an easy-to-follow research report that allows you to clearly detail your research methods, findings, and the insights that you’ve gained from the research being presented. 

This template has a very clear structure, allowing you to simply add the following: an executive summary (brief description), introduction, the methodology used, your results, references, and any necessary appendices if supplementary material needs to be referenced in your research report. 

If you need more templates like this, check out this list of research plan templates .

Companies perform market research in order to define what their customers want and need from them. This type of research also helps you to improve product and service offers and learn more about what your competitors are doing and where the success of other businesses stems from. 

ClickUp’s Market Research Template gives you a simple-to-follow document that helps you gather and present information related to your target audience, the state of your product/service, and the state of your industry at large. 

When you perform marketing research, you are aiming to confirm your hunches about customer needs through scientific research and tangible data. 

Marketing case study examples like this are perfect because they’re very simplified and easily customizable. It offers you a section for presenting your company and why you are performing marketing research first.

The template then guides you in describing the type of research you’re doing, how you went about performing market research, data collection techniques, and what insights were garnered—whether it was from existing or potential customers.

Check out these research management tools !

Another type of customer-centric report that you can put together is a user research report. ClickUp’s User Research Plan Template makes it easy for you to define all of the goals and details that you want included in your user research.

The template is particularly useful for user experience (UX) teams that want to perform user persona research in order to better understand what users need and how they behave when using their product, in order to deliver a better experience to them and to new clients. 

The template starts with a “ problem statement ” where you can define the problem that the user research report is aiming to solve. Next, you’ll list the goals that you want to achieve and then clearly define the research process.

This type of marketing case study template and report can show you what a satisfied customer looks like and give you insights that help to attract and retain future customers.

Check out these user persona templates !

Another important study that your business can perform in order to make smarter decisions is data analysis. ClickUp’s Data Analysis Findings template makes it easy for your team to perform data analysis and present it clearly to key stakeholders. 

This template also starts by setting the stage for the study and explaining it, first with a problem statement and then by explaining the significance of the study. 

Next, the template recommends that you define the scope and limitations of the study to set expectations for its potential impact. The next step is to frame your analysis methods and provide the data sources that you used in the analysis, as well as the statistical methods used.

Finally, you can present your findings in a clear and concise way. The template also includes charts and other data visualization tools you can use to make the study more engaging.

This ClickUp Campaign Report template is pre-built to make it incredibly easy to present the results of any ad campaign to stakeholders very easily. 

It starts with a section describing your strategy in detail, including the total costs, and the total revenue, conversions, and clicks that you expect to achieve with the campaign. 

The marketing case study template then provides charts and graphs that you can use to detail the performance of your campaigns on every single channel that you use. Case study templates like this are great for detailing information on potential customers to know how to better run your campaigns in the future.

Make your next user research project a collaborative, visual experience. Give everyone on your team a chance to add their thoughts and findings with virtual sticky notes using the ClickUp Research Whiteboard Template .

This is one of the more flexible case study templates in this list. Its user research tool makes it easy to take all the random bits of information your team gathers through interviews, surveys, user sessions, and other methods of feedback into one location.

Then, you can quickly organize all of that data into clear categories that make this case study template easy to see at a glance what direction you need to take your project to satisfy your customers.

If you’re writing many case studies, it’s a good idea to try out a bunch of templates over time for added inspiration. Even if you’ve found one structure works great for your case studies, changing your structure up every now and then can give you a fresh perspective on how to present a featured client. 

Another good case study you can check out is Wordstream’s Case Study Template. It has an excellent structure and provides pre-built visual cues that give you some ideas for breaking up business case study examples and making them more appealing with pictures and charts. 

Use this template to showcase particular customers’ results and share customer pain points and how they were solved. This will help you provide clear evidence to potential customers that you will be able to help them as well.

Template.net is one of the biggest websites if you’re looking for business templates. It’s especially popular for businesses that prefer creating documents in Microsoft Word and Excel.

This Case Study Template from Template.net is sparse, but it gets right to the point and is very well-structured and easy to follow.

This Microsoft Word case study template is a great way to get right down to business! It features a clean and organized layout with clear headings and subheadings, making it easy for readers to navigate. This template also includes space for a brief summary of the case study, perfect for giving readers an overview before diving into the details.

This Microsoft Word case study template is a great option for creating an in-depth report on your findings. The template includes sections for an executive summary, introduction, methodology, results, references, and appendices. It also features a clear structure to make it easy to gather and present information in a cohesive manner. The template also includes sections for an introduction, methodology, findings, and recommendations, ensuring that all the essential elements of a case study are covered.

This Word case study template features a professional and organized design with clearly labeled sections for the introduction, methodology, findings, and conclusion. It also includes space for charts and graphs to visually represent data.

Psychology case studies can be complex and detailed, making it important to have a well-organized template to present the information. The Psychology Case Study Template is perfect for this task, with clear headings and subheadings that guide readers through each section of the study. It also includes sections for summarizing key points and providing recommendations based on the findings.

This media case study template from Template.net is perfect for showcasing the success of a marketing or advertising campaign! It includes space for key metrics, such as reach and engagement, and also has sections for outlining the challenges faced and solutions implemented. With its clean design and easy-to-follow layout, this template is ideal for presenting media case studies to clients or stakeholders.

It’s Easy to Make a Case for Using ClickUp Case Study Templates

People trust other people. That’s why personal recommendations are one of the most effective marketing tactics. A case study provides your company with just that—a personal recommendation from a client you’ve helping, telling others that you can do the same for them. 

In the selection process of choosing a product or service to go with, companies will always look at the experiences of other organizations similar to them. Marketing case studies are sincere yet persuasive and clearly show how you help others and can be a very effective differentiator.

ClickUp was designed to serve teams in any industry and of any size. So it makes sense the case study templates we offer are just as diverse and customizable.

Best of all, they are completely free to use!  Sign up for free to ClickUp to get immediate access to a massive amount of templates, free cloud storage, and of course, industry-leading project and team management features.

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World-first “Cybercrime Index” ranks countries by cybercrime threat level

Following three years of intensive research, an international team of researchers have compiled the first ever ‘World Cybercrime Index’, which identifies the globe’s key cybercrime hotspots by ranking the most significant sources of cybercrime at a national level.

The Index, published today in the journal PLOS ONE , shows that a relatively small number of countries house the greatest cybercriminal threat. Russia tops the list, followed by Ukraine, China, the USA, Nigeria, and Romania. The UK comes in at number eight.

‘The research that underpins the Index will help remove the veil of anonymity around cybercriminal offenders, and we hope that it will aid the fight against the growing threat of profit-driven cybercrime,’ Dr Bruce said.

‘We now have a deeper understanding of the geography of cybercrime, and how different countries specialise in different types of cybercrime.’

‘By continuing to collect this data, we’ll be able to monitor the emergence of any new hotspots and it is possible early interventions could be made in at-risk countries before a serious cybercrime problem even develops.’

The data that underpins the Index was gathered through a survey of 92 leading cybercrime experts from around the world who are involved in cybercrime intelligence gathering and investigations. The survey asked the experts to consider five major categories of cybercrime*, nominate the countries that they consider to be the most significant sources of each of these types of cybercrime, and then rank each country according to the impact, professionalism, and technical skill of its cybercriminals.

Co-author Associate Professor Jonathan Lusthaus , from the University of Oxford’s Department of Sociology and Oxford School of Global and Area Studies, said cybercrime has largely been an invisible phenomenon because offenders often mask their physical locations by hiding behind fake profiles and technical protections.

'Due to the illicit and anonymous nature of their activities, cybercriminals cannot be easily accessed or reliably surveyed. They are actively hiding. If you try to use technical data to map their location, you will also fail, as cybercriminals bounce their attacks around internet infrastructure across the world. The best means we have to draw a picture of where these offenders are actually located is to survey those whose job it is to track these people,' Dr Lusthaus said.

Figuring out why some countries are cybercrime hotspots, and others aren't, is the next stage of the research. There are existing theories about why some countries have become hubs of cybercriminal activity - for example, that a technically skilled workforce with few employment opportunities may turn to illicit activity to make ends meet - which we'll be able to test against our global data set. Dr Miranda Bruce  Department of Sociology, University of Oxford and UNSW Canberra   

Co-author of the study, Professor Federico Varese from Sciences Po in France, said the World Cybercrime Index is the first step in a broader aim to understand the local dimensions of cybercrime production across the world.

‘We are hoping to expand the study so that we can determine whether national characteristics like educational attainment, internet penetration, GDP, or levels of corruption are associated with cybercrime. Many people think that cybercrime is global and fluid, but this study supports the view that, much like forms of organised crime, it is embedded within particular contexts,’ Professor Varese said.

The World Cybercrime Index has been developed as a joint partnership between the University of Oxford and UNSW and has also been funded by CRIMGOV , a European Union-supported project based at the University of Oxford and Sciences Po. The other co-authors of the study include Professor Ridhi Kashyap from the University of Oxford and Professor Nigel Phair from Monash University.

The study ‘Mapping the global geography of cybercrime with the World Cybercrime Index’ has been published in the journal PLOS ONE .

*The five major categories of cybercrime assessed by the study were:

1.   Technical products/services (e.g. malware coding, botnet access, access to compromised systems, tool production).

2.   Attacks and extortion (e.g. denial-of-service attacks, ransomware).

3.   Data/identity theft (e.g. hacking, phishing, account compromises, credit card comprises).

4.   Scams (e.g. advance fee fraud, business email compromise, online auction fraud).

5.   Cashing out/money laundering (e.g. credit card fraud, money mules, illicit virtual currency platforms).

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