difference between research paper and case report

Organizing Your Social Sciences Research Assignments

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

Definition and Introduction

Case analysis is a problem-based teaching and learning method that involves critically analyzing complex scenarios within an organizational setting for the purpose of placing the student in a “real world” situation and applying reflection and critical thinking skills to contemplate appropriate solutions, decisions, or recommended courses of action. It is considered a more effective teaching technique than in-class role playing or simulation activities. The analytical process is often guided by questions provided by the instructor that ask students to contemplate relationships between the facts and critical incidents described in the case.

Cases generally include both descriptive and statistical elements and rely on students applying abductive reasoning to develop and argue for preferred or best outcomes [i.e., case scenarios rarely have a single correct or perfect answer based on the evidence provided]. Rather than emphasizing theories or concepts, case analysis assignments emphasize building a bridge of relevancy between abstract thinking and practical application and, by so doing, teaches the value of both within a specific area of professional practice.

Given this, the purpose of a case analysis paper is to present a structured and logically organized format for analyzing the case situation. It can be assigned to students individually or as a small group assignment and it may include an in-class presentation component. Case analysis is predominately taught in economics and business-related courses, but it is also a method of teaching and learning found in other applied social sciences disciplines, such as, social work, public relations, education, journalism, and public administration.

Ellet, William. The Case Study Handbook: A Student's Guide . Revised Edition. Boston, MA: Harvard Business School Publishing, 2018; Christoph Rasche and Achim Seisreiner. Guidelines for Business Case Analysis . University of Potsdam; Writing a Case Analysis . Writing Center, Baruch College; Volpe, Guglielmo. "Case Teaching in Economics: History, Practice and Evidence." Cogent Economics and Finance 3 (December 2015). doi:https://doi.org/10.1080/23322039.2015.1120977.

How to Approach Writing a Case Analysis Paper

The organization and structure of a case analysis paper can vary depending on the organizational setting, the situation, and how your professor wants you to approach the assignment. Nevertheless, preparing to write a case analysis paper involves several important steps. As Hawes notes, a case analysis assignment “...is useful in developing the ability to get to the heart of a problem, analyze it thoroughly, and to indicate the appropriate solution as well as how it should be implemented” [p.48]. This statement encapsulates how you should approach preparing to write a case analysis paper.

Before you begin to write your paper, consider the following analytical procedures:

• Review the case to get an overview of the situation . A case can be only a few pages in length, however, it is most often very lengthy and contains a significant amount of detailed background information and statistics, with multilayered descriptions of the scenario, the roles and behaviors of various stakeholder groups, and situational events. Therefore, a quick reading of the case will help you gain an overall sense of the situation and illuminate the types of issues and problems that you will need to address in your paper. If your professor has provided questions intended to help frame your analysis, use them to guide your initial reading of the case.
• Read the case thoroughly . After gaining a general overview of the case, carefully read the content again with the purpose of understanding key circumstances, events, and behaviors among stakeholder groups. Look for information or data that appears contradictory, extraneous, or misleading. At this point, you should be taking notes as you read because this will help you develop a general outline of your paper. The aim is to obtain a complete understanding of the situation so that you can begin contemplating tentative answers to any questions your professor has provided or, if they have not provided, developing answers to your own questions about the case scenario and its connection to the course readings,lectures, and class discussions.
• Determine key stakeholder groups, issues, and events and the relationships they all have to each other . As you analyze the content, pay particular attention to identifying individuals, groups, or organizations described in the case and identify evidence of any problems or issues of concern that impact the situation in a negative way. Other things to look for include identifying any assumptions being made by or about each stakeholder, potential biased explanations or actions, explicit demands or ultimatums , and the underlying concerns that motivate these behaviors among stakeholders. The goal at this stage is to develop a comprehensive understanding of the situational and behavioral dynamics of the case and the explicit and implicit consequences of each of these actions.
• Identify the core problems . The next step in most case analysis assignments is to discern what the core [i.e., most damaging, detrimental, injurious] problems are within the organizational setting and to determine their implications. The purpose at this stage of preparing to write your analysis paper is to distinguish between the symptoms of core problems and the core problems themselves and to decide which of these must be addressed immediately and which problems do not appear critical but may escalate over time. Identify evidence from the case to support your decisions by determining what information or data is essential to addressing the core problems and what information is not relevant or is misleading.
• Explore alternative solutions . As noted, case analysis scenarios rarely have only one correct answer. Therefore, it is important to keep in mind that the process of analyzing the case and diagnosing core problems, while based on evidence, is a subjective process open to various avenues of interpretation. This means that you must consider alternative solutions or courses of action by critically examining strengths and weaknesses, risk factors, and the differences between short and long-term solutions. For each possible solution or course of action, consider the consequences they may have related to their implementation and how these recommendations might lead to new problems. Also, consider thinking about your recommended solutions or courses of action in relation to issues of fairness, equity, and inclusion.
• Decide on a final set of recommendations . The last stage in preparing to write a case analysis paper is to assert an opinion or viewpoint about the recommendations needed to help resolve the core problems as you see them and to make a persuasive argument for supporting this point of view. Prepare a clear rationale for your recommendations based on examining each element of your analysis. Anticipate possible obstacles that could derail their implementation. Consider any counter-arguments that could be made concerning the validity of your recommended actions. Finally, describe a set of criteria and measurable indicators that could be applied to evaluating the effectiveness of your implementation plan.

Use these steps as the framework for writing your paper. Remember that the more detailed you are in taking notes as you critically examine each element of the case, the more information you will have to draw from when you begin to write. This will save you time.

NOTE : If the process of preparing to write a case analysis paper is assigned as a student group project, consider having each member of the group analyze a specific element of the case, including drafting answers to the corresponding questions used by your professor to frame the analysis. This will help make the analytical process more efficient and ensure that the distribution of work is equitable. This can also facilitate who is responsible for drafting each part of the final case analysis paper and, if applicable, the in-class presentation.

Framework for Case Analysis . College of Management. University of Massachusetts; Hawes, Jon M. "Teaching is Not Telling: The Case Method as a Form of Interactive Learning." Journal for Advancement of Marketing Education 5 (Winter 2004): 47-54; Rasche, Christoph and Achim Seisreiner. Guidelines for Business Case Analysis . University of Potsdam; Writing a Case Study Analysis . University of Arizona Global Campus Writing Center; Van Ness, Raymond K. A Guide to Case Analysis . School of Business. State University of New York, Albany; Writing a Case Analysis . Business School, University of New South Wales.

Structure and Writing Style

A case analysis paper should be detailed, concise, persuasive, clearly written, and professional in tone and in the use of language . As with other forms of college-level academic writing, declarative statements that convey information, provide a fact, or offer an explanation or any recommended courses of action should be based on evidence. If allowed by your professor, any external sources used to support your analysis, such as course readings, should be properly cited under a list of references. The organization and structure of case analysis papers can vary depending on your professor’s preferred format, but its structure generally follows the steps used for analyzing the case.

Introduction

The introduction should provide a succinct but thorough descriptive overview of the main facts, issues, and core problems of the case . The introduction should also include a brief summary of the most relevant details about the situation and organizational setting. This includes defining the theoretical framework or conceptual model on which any questions were used to frame your analysis.

Following the rules of most college-level research papers, the introduction should then inform the reader how the paper will be organized. This includes describing the major sections of the paper and the order in which they will be presented. Unless you are told to do so by your professor, you do not need to preview your final recommendations in the introduction. U nlike most college-level research papers , the introduction does not include a statement about the significance of your findings because a case analysis assignment does not involve contributing new knowledge about a research problem.

Background Analysis

Background analysis can vary depending on any guiding questions provided by your professor and the underlying concept or theory that the case is based upon. In general, however, this section of your paper should focus on:

• Providing an overarching analysis of problems identified from the case scenario, including identifying events that stakeholders find challenging or troublesome,
• Identifying assumptions made by each stakeholder and any apparent biases they may exhibit,
• Describing any demands or claims made by or forced upon key stakeholders, and
• Highlighting any issues of concern or complaints expressed by stakeholders in response to those demands or claims.

These aspects of the case are often in the form of behavioral responses expressed by individuals or groups within the organizational setting. However, note that problems in a case situation can also be reflected in data [or the lack thereof] and in the decision-making, operational, cultural, or institutional structure of the organization. Additionally, demands or claims can be either internal and external to the organization [e.g., a case analysis involving a president considering arms sales to Saudi Arabia could include managing internal demands from White House advisors as well as demands from members of Congress].

Throughout this section, present all relevant evidence from the case that supports your analysis. Do not simply claim there is a problem, an assumption, a demand, or a concern; tell the reader what part of the case informed how you identified these background elements.

Identification of Problems

In most case analysis assignments, there are problems, and then there are problems . Each problem can reflect a multitude of underlying symptoms that are detrimental to the interests of the organization. The purpose of identifying problems is to teach students how to differentiate between problems that vary in severity, impact, and relative importance. Given this, problems can be described in three general forms: those that must be addressed immediately, those that should be addressed but the impact is not severe, and those that do not require immediate attention and can be set aside for the time being.

All of the problems you identify from the case should be identified in this section of your paper, with a description based on evidence explaining the problem variances. If the assignment asks you to conduct research to further support your assessment of the problems, include this in your explanation. Remember to cite those sources in a list of references. Use specific evidence from the case and apply appropriate concepts, theories, and models discussed in class or in relevant course readings to highlight and explain the key problems [or problem] that you believe must be solved immediately and describe the underlying symptoms and why they are so critical.

Alternative Solutions

This section is where you provide specific, realistic, and evidence-based solutions to the problems you have identified and make recommendations about how to alleviate the underlying symptomatic conditions impacting the organizational setting. For each solution, you must explain why it was chosen and provide clear evidence to support your reasoning. This can include, for example, course readings and class discussions as well as research resources, such as, books, journal articles, research reports, or government documents. In some cases, your professor may encourage you to include personal, anecdotal experiences as evidence to support why you chose a particular solution or set of solutions. Using anecdotal evidence helps promote reflective thinking about the process of determining what qualifies as a core problem and relevant solution .

Throughout this part of the paper, keep in mind the entire array of problems that must be addressed and describe in detail the solutions that might be implemented to resolve these problems.

Recommended Courses of Action

In some case analysis assignments, your professor may ask you to combine the alternative solutions section with your recommended courses of action. However, it is important to know the difference between the two. A solution refers to the answer to a problem. A course of action refers to a procedure or deliberate sequence of activities adopted to proactively confront a situation, often in the context of accomplishing a goal. In this context, proposed courses of action are based on your analysis of alternative solutions. Your description and justification for pursuing each course of action should represent the overall plan for implementing your recommendations.

For each course of action, you need to explain the rationale for your recommendation in a way that confronts challenges, explains risks, and anticipates any counter-arguments from stakeholders. Do this by considering the strengths and weaknesses of each course of action framed in relation to how the action is expected to resolve the core problems presented, the possible ways the action may affect remaining problems, and how the recommended action will be perceived by each stakeholder.

In addition, you should describe the criteria needed to measure how well the implementation of these actions is working and explain which individuals or groups are responsible for ensuring your recommendations are successful. In addition, always consider the law of unintended consequences. Outline difficulties that may arise in implementing each course of action and describe how implementing the proposed courses of action [either individually or collectively] may lead to new problems [both large and small].

Throughout this section, you must consider the costs and benefits of recommending your courses of action in relation to uncertainties or missing information and the negative consequences of success.

The conclusion should be brief and introspective. Unlike a research paper, the conclusion in a case analysis paper does not include a summary of key findings and their significance, a statement about how the study contributed to existing knowledge, or indicate opportunities for future research.

Begin by synthesizing the core problems presented in the case and the relevance of your recommended solutions. This can include an explanation of what you have learned about the case in the context of your answers to the questions provided by your professor. The conclusion is also where you link what you learned from analyzing the case with the course readings or class discussions. This can further demonstrate your understanding of the relationships between the practical case situation and the theoretical and abstract content of assigned readings and other course content.

Problems to Avoid

The literature on case analysis assignments often includes examples of difficulties students have with applying methods of critical analysis and effectively reporting the results of their assessment of the situation. A common reason cited by scholars is that the application of this type of teaching and learning method is limited to applied fields of social and behavioral sciences and, as a result, writing a case analysis paper can be unfamiliar to most students entering college.

After you have drafted your paper, proofread the narrative flow and revise any of these common errors:

• Unnecessary detail in the background section . The background section should highlight the essential elements of the case based on your analysis. Focus on summarizing the facts and highlighting the key factors that become relevant in the other sections of the paper by eliminating any unnecessary information.
• Analysis relies too much on opinion . Your analysis is interpretive, but the narrative must be connected clearly to evidence from the case and any models and theories discussed in class or in course readings. Any positions or arguments you make should be supported by evidence.
• Analysis does not focus on the most important elements of the case . Your paper should provide a thorough overview of the case. However, the analysis should focus on providing evidence about what you identify are the key events, stakeholders, issues, and problems. Emphasize what you identify as the most critical aspects of the case to be developed throughout your analysis. Be thorough but succinct.
• Writing is too descriptive . A paper with too much descriptive information detracts from your analysis of the complexities of the case situation. Questions about what happened, where, when, and by whom should only be included as essential information leading to your examination of questions related to why, how, and for what purpose.
• Inadequate definition of a core problem and associated symptoms . A common error found in case analysis papers is recommending a solution or course of action without adequately defining or demonstrating that you understand the problem. Make sure you have clearly described the problem and its impact and scope within the organizational setting. Ensure that you have adequately described the root causes w hen describing the symptoms of the problem.
• Recommendations lack specificity . Identify any use of vague statements and indeterminate terminology, such as, “A particular experience” or “a large increase to the budget.” These statements cannot be measured and, as a result, there is no way to evaluate their successful implementation. Provide specific data and use direct language in describing recommended actions.
• Unrealistic, exaggerated, or unattainable recommendations . Review your recommendations to ensure that they are based on the situational facts of the case. Your recommended solutions and courses of action must be based on realistic assumptions and fit within the constraints of the situation. Also note that the case scenario has already happened, therefore, any speculation or arguments about what could have occurred if the circumstances were different should be revised or eliminated.

Bee, Lian Song et al. "Business Students' Perspectives on Case Method Coaching for Problem-Based Learning: Impacts on Student Engagement and Learning Performance in Higher Education." Education & Training 64 (2022): 416-432; The Case Analysis . Fred Meijer Center for Writing and Michigan Authors. Grand Valley State University; Georgallis, Panikos and Kayleigh Bruijn. "Sustainability Teaching using Case-Based Debates." Journal of International Education in Business 15 (2022): 147-163; Hawes, Jon M. "Teaching is Not Telling: The Case Method as a Form of Interactive Learning." Journal for Advancement of Marketing Education 5 (Winter 2004): 47-54; Georgallis, Panikos, and Kayleigh Bruijn. "Sustainability Teaching Using Case-based Debates." Journal of International Education in Business 15 (2022): 147-163; .Dean,  Kathy Lund and Charles J. Fornaciari. "How to Create and Use Experiential Case-Based Exercises in a Management Classroom." Journal of Management Education 26 (October 2002): 586-603; Klebba, Joanne M. and Janet G. Hamilton. "Structured Case Analysis: Developing Critical Thinking Skills in a Marketing Case Course." Journal of Marketing Education 29 (August 2007): 132-137, 139; Klein, Norman. "The Case Discussion Method Revisited: Some Questions about Student Skills." Exchange: The Organizational Behavior Teaching Journal 6 (November 1981): 30-32; Mukherjee, Arup. "Effective Use of In-Class Mini Case Analysis for Discovery Learning in an Undergraduate MIS Course." The Journal of Computer Information Systems 40 (Spring 2000): 15-23; Pessoa, Silviaet al. "Scaffolding the Case Analysis in an Organizational Behavior Course: Making Analytical Language Explicit." Journal of Management Education 46 (2022): 226-251: Ramsey, V. J. and L. D. Dodge. "Case Analysis: A Structured Approach." Exchange: The Organizational Behavior Teaching Journal 6 (November 1981): 27-29; Schweitzer, Karen. "How to Write and Format a Business Case Study." ThoughtCo. https://www.thoughtco.com/how-to-write-and-format-a-business-case-study-466324 (accessed December 5, 2022); Reddy, C. D. "Teaching Research Methodology: Everything's a Case." Electronic Journal of Business Research Methods 18 (December 2020): 178-188; Volpe, Guglielmo. "Case Teaching in Economics: History, Practice and Evidence." Cogent Economics and Finance 3 (December 2015). doi:https://doi.org/10.1080/23322039.2015.1120977.

Writing Tip

Ca se Study and Case Analysis Are Not the Same!

Confusion often exists between what it means to write a paper that uses a case study research design and writing a paper that analyzes a case; they are two different types of approaches to learning in the social and behavioral sciences. Professors as well as educational researchers contribute to this confusion because they often use the term "case study" when describing the subject of analysis for a case analysis paper. But you are not studying a case for the purpose of generating a comprehensive, multi-faceted understanding of a research problem. R ather, you are critically analyzing a specific scenario to argue logically for recommended solutions and courses of action that lead to optimal outcomes applicable to professional practice.

To avoid any confusion, here are twelve characteristics that delineate the differences between writing a paper using the case study research method and writing a case analysis paper:

• Case study is a method of in-depth research and rigorous inquiry ; case analysis is a reliable method of teaching and learning . A case study is a modality of research that investigates a phenomenon for the purpose of creating new knowledge, solving a problem, or testing a hypothesis using empirical evidence derived from the case being studied. Often, the results are used to generalize about a larger population or within a wider context. The writing adheres to the traditional standards of a scholarly research study. A case analysis is a pedagogical tool used to teach students how to reflect and think critically about a practical, real-life problem in an organizational setting.
• The researcher is responsible for identifying the case to study; a case analysis is assigned by your professor . As the researcher, you choose the case study to investigate in support of obtaining new knowledge and understanding about the research problem. The case in a case analysis assignment is almost always provided, and sometimes written, by your professor and either given to every student in class to analyze individually or to a small group of students, or students select a case to analyze from a predetermined list.
• A case study is indeterminate and boundless; a case analysis is predetermined and confined . A case study can be almost anything [see item 9 below] as long as it relates directly to examining the research problem. This relationship is the only limit to what a researcher can choose as the subject of their case study. The content of a case analysis is determined by your professor and its parameters are well-defined and limited to elucidating insights of practical value applied to practice.
• Case study is fact-based and describes actual events or situations; case analysis can be entirely fictional or adapted from an actual situation . The entire content of a case study must be grounded in reality to be a valid subject of investigation in an empirical research study. A case analysis only needs to set the stage for critically examining a situation in practice and, therefore, can be entirely fictional or adapted, all or in-part, from an actual situation.
• Research using a case study method must adhere to principles of intellectual honesty and academic integrity; a case analysis scenario can include misleading or false information . A case study paper must report research objectively and factually to ensure that any findings are understood to be logically correct and trustworthy. A case analysis scenario may include misleading or false information intended to deliberately distract from the central issues of the case. The purpose is to teach students how to sort through conflicting or useless information in order to come up with the preferred solution. Any use of misleading or false information in academic research is considered unethical.
• Case study is linked to a research problem; case analysis is linked to a practical situation or scenario . In the social sciences, the subject of an investigation is most often framed as a problem that must be researched in order to generate new knowledge leading to a solution. Case analysis narratives are grounded in real life scenarios for the purpose of examining the realities of decision-making behavior and processes within organizational settings. A case analysis assignments include a problem or set of problems to be analyzed. However, the goal is centered around the act of identifying and evaluating courses of action leading to best possible outcomes.
• The purpose of a case study is to create new knowledge through research; the purpose of a case analysis is to teach new understanding . Case studies are a choice of methodological design intended to create new knowledge about resolving a research problem. A case analysis is a mode of teaching and learning intended to create new understanding and an awareness of uncertainty applied to practice through acts of critical thinking and reflection.
• A case study seeks to identify the best possible solution to a research problem; case analysis can have an indeterminate set of solutions or outcomes . Your role in studying a case is to discover the most logical, evidence-based ways to address a research problem. A case analysis assignment rarely has a single correct answer because one of the goals is to force students to confront the real life dynamics of uncertainly, ambiguity, and missing or conflicting information within professional practice. Under these conditions, a perfect outcome or solution almost never exists.
• Case study is unbounded and relies on gathering external information; case analysis is a self-contained subject of analysis . The scope of a case study chosen as a method of research is bounded. However, the researcher is free to gather whatever information and data is necessary to investigate its relevance to understanding the research problem. For a case analysis assignment, your professor will often ask you to examine solutions or recommended courses of action based solely on facts and information from the case.
• Case study can be a person, place, object, issue, event, condition, or phenomenon; a case analysis is a carefully constructed synopsis of events, situations, and behaviors . The research problem dictates the type of case being studied and, therefore, the design can encompass almost anything tangible as long as it fulfills the objective of generating new knowledge and understanding. A case analysis is in the form of a narrative containing descriptions of facts, situations, processes, rules, and behaviors within a particular setting and under a specific set of circumstances.
• Case study can represent an open-ended subject of inquiry; a case analysis is a narrative about something that has happened in the past . A case study is not restricted by time and can encompass an event or issue with no temporal limit or end. For example, the current war in Ukraine can be used as a case study of how medical personnel help civilians during a large military conflict, even though circumstances around this event are still evolving. A case analysis can be used to elicit critical thinking about current or future situations in practice, but the case itself is a narrative about something finite and that has taken place in the past.
• Multiple case studies can be used in a research study; case analysis involves examining a single scenario . Case study research can use two or more cases to examine a problem, often for the purpose of conducting a comparative investigation intended to discover hidden relationships, document emerging trends, or determine variations among different examples. A case analysis assignment typically describes a stand-alone, self-contained situation and any comparisons among cases are conducted during in-class discussions and/or student presentations.

The Case Analysis . Fred Meijer Center for Writing and Michigan Authors. Grand Valley State University; Mills, Albert J. , Gabrielle Durepos, and Eiden Wiebe, editors. Encyclopedia of Case Study Research . Thousand Oaks, CA: SAGE Publications, 2010; Ramsey, V. J. and L. D. Dodge. "Case Analysis: A Structured Approach." Exchange: The Organizational Behavior Teaching Journal 6 (November 1981): 27-29; Yin, Robert K. Case Study Research and Applications: Design and Methods . 6th edition. Thousand Oaks, CA: Sage, 2017; Crowe, Sarah et al. “The Case Study Approach.” BMC Medical Research Methodology 11 (2011):  doi: 10.1186/1471-2288-11-100; Yin, Robert K. Case Study Research: Design and Methods . 4th edition. Thousand Oaks, CA: Sage Publishing; 1994.

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Distinguishing case study as a research method from case reports as a publication type

• Kristine M. Alpi William R. Kenan, Jr. Library of Veterinary Medicine, North Carolina State University, Raleigh, NC http://orcid.org/0000-0002-4521-3523
• John Jamal Evans North Carolina Community College System, Raleigh, NC

Author Biography

Kristine m. alpi, william r. kenan, jr. library of veterinary medicine, north carolina state university, raleigh, nc.

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Scientific Manuscript Writing: Original Research, Case Reports, Review Articles

• First Online: 02 March 2024

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• Kimberly M. Rathbun 5  

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Manuscripts are used to communicate the findings of your work with other researchers. Writing your first manuscript can be a challenge. Journals provide guidelines to authors which should be followed closely. The three major types of articles (original research, case reports, and review articles) all generally follow the IMRAD format with slight variations in content. With planning and thought, manuscript writing does not have to be a daunting task.

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Kahyun Yoon-Flannery

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Rathbun, K.M. (2023). Scientific Manuscript Writing: Original Research, Case Reports, Review Articles. In: Olympia, R.P., Werley, E.B., Lubin, J.S., Yoon-Flannery, K. (eds) An Emergency Physician’s Path. Springer, Cham. https://doi.org/10.1007/978-3-031-47873-4_80

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Case Study vs. Research

What's the difference.

Case study and research are both methods used in academic and professional settings to gather information and gain insights. However, they differ in their approach and purpose. A case study is an in-depth analysis of a specific individual, group, or situation, aiming to understand the unique characteristics and dynamics involved. It often involves qualitative data collection methods such as interviews, observations, and document analysis. On the other hand, research is a systematic investigation conducted to generate new knowledge or validate existing theories. It typically involves a larger sample size and employs quantitative data collection methods such as surveys, experiments, or statistical analysis. While case studies provide detailed and context-specific information, research aims to generalize findings to a broader population.

Further Detail

Introduction.

When it comes to conducting studies and gathering information, researchers have various methods at their disposal. Two commonly used approaches are case study and research. While both methods aim to explore and understand a particular subject, they differ in their approach, scope, and the type of data they collect. In this article, we will delve into the attributes of case study and research, highlighting their similarities and differences.

A case study is an in-depth analysis of a specific individual, group, event, or phenomenon. It involves a detailed examination of a particular case to gain insights into its unique characteristics, context, and dynamics. Case studies often employ multiple sources of data, such as interviews, observations, and documents, to provide a comprehensive understanding of the subject under investigation.

One of the key attributes of a case study is its focus on a specific case, which allows researchers to explore complex and nuanced aspects of the subject. By examining a single case in detail, researchers can uncover rich and detailed information that may not be possible with broader research methods. Case studies are particularly useful when studying rare or unique phenomena, as they provide an opportunity to deeply analyze and understand them.

Furthermore, case studies often employ qualitative research methods, emphasizing the collection of non-numerical data. This qualitative approach allows researchers to capture the subjective experiences, perspectives, and motivations of the individuals or groups involved in the case. By using open-ended interviews and observations, researchers can gather rich and detailed data that provides a holistic view of the subject.

However, it is important to note that case studies have limitations. Due to their focus on a specific case, the findings may not be easily generalized to a larger population or context. The small sample size and unique characteristics of the case may limit the generalizability of the results. Additionally, the subjective nature of qualitative data collection in case studies may introduce bias or interpretation challenges.

Research, on the other hand, is a systematic investigation aimed at discovering new knowledge or validating existing theories. It involves the collection, analysis, and interpretation of data to answer research questions or test hypotheses. Research can be conducted using various methods, including surveys, experiments, and statistical analysis, depending on the nature of the study.

One of the primary attributes of research is its emphasis on generating generalizable knowledge. By using representative samples and statistical techniques, researchers aim to draw conclusions that can be applied to a larger population or context. This allows for the identification of patterns, trends, and relationships that can inform theories, policies, or practices.

Research often employs quantitative methods, focusing on the collection of numerical data that can be analyzed using statistical techniques. Surveys, experiments, and statistical analysis allow researchers to measure variables, establish correlations, and test hypotheses. This objective approach provides a level of objectivity and replicability that is crucial for scientific inquiry.

However, research also has its limitations. The focus on generalizability may sometimes sacrifice the depth and richness of understanding that case studies offer. The reliance on quantitative data may overlook important qualitative aspects of the subject, such as individual experiences or contextual factors. Additionally, the controlled nature of research settings may not fully capture the complexity and dynamics of real-world situations.

Similarities

Despite their differences, case studies and research share some common attributes. Both methods aim to gather information and generate knowledge about a particular subject. They require careful planning, data collection, analysis, and interpretation. Both case studies and research contribute to the advancement of knowledge in their respective fields.

Furthermore, both case studies and research can be used in various disciplines, including social sciences, psychology, business, and healthcare. They provide valuable insights and contribute to evidence-based decision-making. Whether it is understanding the impact of a new treatment, exploring consumer behavior, or investigating social phenomena, both case studies and research play a crucial role in expanding our understanding of the world.

In conclusion, case study and research are two distinct yet valuable approaches to studying and understanding a subject. Case studies offer an in-depth analysis of a specific case, providing rich and detailed information that may not be possible with broader research methods. On the other hand, research aims to generate generalizable knowledge by using representative samples and quantitative methods. While case studies emphasize qualitative data collection, research focuses on quantitative analysis. Both methods have their strengths and limitations, and their choice depends on the research objectives, scope, and context. By utilizing the appropriate method, researchers can gain valuable insights and contribute to the advancement of knowledge in their respective fields.

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Types of journal articles

It is helpful to familiarise yourself with the different types of articles published by journals. Although it may appear there are a large number of types of articles published due to the wide variety of names they are published under, most articles published are one of the following types; Original Research, Review Articles, Short reports or Letters, Case Studies, Methodologies.

Original Research:

This is the most common type of journal manuscript used to publish full reports of data from research. It may be called an  Original Article, Research Article, Research, or just  Article, depending on the journal. The Original Research format is suitable for many different fields and different types of studies. It includes full Introduction, Methods, Results, and Discussion sections.

Short reports or Letters:

These papers communicate brief reports of data from original research that editors believe will be interesting to many researchers, and that will likely stimulate further research in the field. As they are relatively short the format is useful for scientists with results that are time sensitive (for example, those in highly competitive or quickly-changing disciplines). This format often has strict length limits, so some experimental details may not be published until the authors write a full Original Research manuscript. These papers are also sometimes called Brief communications .

Review Articles:

Review Articles provide a comprehensive summary of research on a certain topic, and a perspective on the state of the field and where it is heading. They are often written by leaders in a particular discipline after invitation from the editors of a journal. Reviews are often widely read (for example, by researchers looking for a full introduction to a field) and highly cited. Reviews commonly cite approximately 100 primary research articles.

TIP: If you would like to write a Review but have not been invited by a journal, be sure to check the journal website as some journals to not consider unsolicited Reviews. If the website does not mention whether Reviews are commissioned it is wise to send a pre-submission enquiry letter to the journal editor to propose your Review manuscript before you spend time writing it.  

Case Studies:

These articles report specific instances of interesting phenomena. A goal of Case Studies is to make other researchers aware of the possibility that a specific phenomenon might occur. This type of study is often used in medicine to report the occurrence of previously unknown or emerging pathologies.

Methodologies or Methods

These articles present a new experimental method, test or procedure. The method described may either be completely new, or may offer a better version of an existing method. The article should describe a demonstrable advance on what is currently available.

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Research Paper vs Report: Breaking Down the Difference

The purpose of this article is to discuss the distinct differences between a research paper and a report. As academic writing has evolved, so too have the structures used to convey information in an organized and succinct manner. The distinctions between these two types of scholarly work are important for any student or researcher engaging in research-based activities as they can make all the difference when it comes to effectively conveying ideas and results accurately. This article will take an in-depth look at both reports and papers, discussing their similarities, differences, components, uses, and best practices for producing quality products that serve their intended purpose properly.

I. Introduction to Research Paper and Report Writing

Ii. defining the differences between a research paper and report, iii. creating an outline for your project, iv. structuring the body of your work, v. ensuring proper citation techniques are utilized in your work, vi. finalizing, editing and publishing the completed project, vii. conclusion: comparing the benefits of writing either a research paper or report.

Research Paper and Report Writing: Writing research papers and reports can be challenging, especially for students who are new to the field of academic writing. Yet these two distinct forms of written communication are essential components in higher education. It is important to understand the differences between a research paper and a report so that one can approach each assignment with clarity of purpose and expectation from their readers.

In academic writing, there are two distinct types of documents which have important distinctions: the research paper and the report. Both styles require different approaches in terms of structure and content.

A research paper is a type of composition that requires its author to investigate an idea or concept through scholarly sources; it must then be presented in a written format. This style typically focuses on one particular point or argument with evidence used to back up assertions made throughout the document.

The main purpose of this type of work is usually to inform readers about certain topics while utilizing personal analysis as well as gathering information from credible sources. As such, it often contains detailed descriptions and explanations based upon current findings within relevant subject areas.

It’s also worth noting that most research papers will contain conclusions drawn by their authors regarding their respective fields – although these can take many forms including opinions, deductions, predictions etc.

A report differs from a research paper primarily because its focus lies more upon summarizing existing material rather than introducing new ideas. It’s generally defined as an orderly account containing facts pertaining to some aspect or aspects being investigated; reports tend not to offer recommendations nor do they include critical assessments. Reports are designed for specific audiences – academics, businesses etc., meaning they should always adhere closely to established guidelines depending on their target reader-base. Additionally, while visual elements may be included such as diagrams/charts/pictures etc.; text makes up the majority of any given report – usually accompanied by headings so points can easily be referenced at later stages.

Organizing Your Ideas Developing an outline for your project is one of the most important steps in the writing process. Not only will it help you get organized, but it also helps to set up a timeline and structure that can be followed while working on each section. Additionally, creating an outline allows you to brainstorm ideas related to your topic and decide which points are worth exploring further during research. When crafting an outline, two main elements must be taken into account: the type of paper being written (research paper or report) as well as its purpose (informative or persuasive). Depending on whether a student is tasked with producing a research paper or report for their assignment, they should tailor their outlining approach accordingly. Research papers typically include more detailed information compared to reports because they explore topics from different angles and require greater analysis from the author’s end; whereas reports focus mainly on summarising collected data rather than drawing conclusions about them.

When writing a research paper, you are creating something that is meant to be read and understood by an audience. It’s important to structure the body of your work in such a way as to make it easier for readers to follow along with the information being presented. The same holds true when structuring reports.

• Research Paper:

When putting together your research paper, create clear and concise points which explain why or how certain things occur within the subject material being discussed. Additionally, try including sources from credible authors who have conducted similar studies on this topic for added credibility. Finally, use subheadings throughout each section of your essay so that readers can easily move between topics without having to re-read previous paragraphs or pages.

Correct Citation Practices for Reports and Research Papers

Having the correct citation practices in place is essential to any report or research paper. Properly citing sources helps ensure accuracy of information, provides readers with further resources for additional context, and helps to protect you from plagiarism. To create effective citations, there are a few key steps that should be followed.

The first step is understanding the difference between reports and research papers – as each type will have different requirements when it comes to citation techniques. A report is an organized collection of facts related to a certain topic; these types of documents usually do not require citations but still need accurate documentation if needed information came from another source (such as books or articles). On the other hand, a research paper requires more than just listing facts – it requires critical analysis which means citations must be used throughout in order reference work done by other authors. When creating citations within this kind of document its important they follow whatever format has been specified (e.g., APA style).

• (Italicize) Report: An organized collection of facts relating to a certain topic.
• (Bold) Research Paper: Requires critical analysis and needs references throughout using an appropriate citation style such as APA.

The process of finalizing, editing and publishing a completed project can be overwhelming but also highly rewarding. Once you have achieved the desired results from your hard work and research, it’s time to bring all the pieces together for presentation to an audience.

It is important to note that there are different approaches when finalizing projects depending on whether it is a report or a research paper. Reports typically involve summarizing findings in easy-to-understand language, while research papers may require more depth as well as citing sources throughout the document.

• When finalizing reports:

Ensure data accuracy by verifying facts before presenting them; make sure content is concisely written with clarity; review any visuals included in order to ensure they accurately portray ideas being discussed; proofread multiple times before sharing information with colleagues or readership at large.

• When finalizing research papers:

Perform extensive literature reviews on topics related to main argument(s) made within paper; include citations where appropriate according to chosen formatting style guidelines (APA, MLA etc); double check if any interviews conducted during course of investigation need additional context added prior to submission/publication; use own voice throughout text but remain objective when making statements about other scholars’ works.

In conclusion, both research papers and reports offer distinct advantages. While it may be difficult to definitively say which type of writing is better overall, the right one for a given situation can depend on an individual’s needs or interests.

Research papers are beneficial when trying to dive deeply into any given topic. They often involve extensive research from outside sources as well as original analysis by the author. Additionally, they can also provide valuable perspectives that help readers gain new insights about their subject matter in a unique way.

On the other hand, reports present information in a more straightforward manner with fewer details than what’s found in research papers but still enough substance to make them useful for decision-making processes or problem solving tasks where precise facts need to be presented quickly and accurately. They tend to focus more on summaries rather than interpretations while avoiding excessive technical jargon so they remain accessible even if readers don’t have expert knowledge of the subject being discussed.

• It’s clear that each form of writing has its own set of benefits

, making them both essential components of scholarly communication no matter what field you specialize in!

English: In conclusion, the difference between a research paper and a report is of great significance. Research papers require more in-depth exploration into the subject matter while reports are typically summaries or reviews of relevant information on an issue. It is important to recognize this distinction when approaching any writing assignment that may require either format. By understanding what constitutes each type of document, students can develop their skills in both areas as well as become better equipped to tackle challenging academic tasks with confidence.

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Basics of case report form designing in clinical research

Shantala bellary.

Global Medical Affairs, Dr. Reddy's Laboratories Ltd., Hyderabad, India

Binny Krishnankutty

1 Clinical Research, USV Limited, Mumbai, India

M. S. Latha

Case report form (CRF) is a specialized document in clinical research. It should be study protocol driven, robust in content and have material to collect the study specific data. Though paper CRFs are still used largely, use of electronic CRFs (eCRFS) are gaining popularity due to the advantages they offer such as improved data quality, online discrepancy management and faster database lock etc. Main objectives behind CRF development are preserving and maintaining quality and integrity of data. CRF design should be standardized to address the needs of all users such as investigator, site coordinator, study monitor, data entry personnel, medical coder and statistician. Data should be organized in a format that facilitates and simplifies data analysis. Collection of large amount of data will result in wasted resources in collecting and processing it and in many circumstances, will not be utilized for analysis. Apart from that, standard guidelines should be followed while designing the CRF. CRF completion manual should be provided to the site personnel to promote accurate data entry by them. These measures will result in reduced query generations and improved data integrity. It is recommended to establish and maintain a library of templates of standard CRF modules as they are time saving and cost-effective. This article is an attempt to describe the methods of CRF designing in clinical research and discusses the challenges encountered in this process.

INTRODUCTION

A case report form (CRF) is designed to collect the patient data in a clinical trial; its development represents a significant part of the clinical trial and can affect study success.[ 1 ] Site personnel capture the subject's data on the CRF, which is collected during their participation in a clinical trial. The International Conference on Harmonization Guidelines for Good Clinical Practice define the CRF as: A printed, optical or electronic document designed to record all of the protocol – required information to be reported to the sponsor on each trial subject.[ 2 ]

Case report form designing requires enormous planning and attention to minute detail. Designing a CRF is crucial in a clinical trial as it will aid in assessing the safety and efficacy of the medicinal product accurately. CRF should be designed for optimal collection of data in accordance with the study protocol compliance, regulatory requirements and shall enable the researcher test the hypothesis or answer the trial related questions.

A well-designed CRF should represent the essential contents of the study protocol and in an ideal situation, CRF is designed once the study protocol is finalized. It can be prepared either concurrently along with the protocol development, but may result in many versions, and hence needs to be version controlled. Timing of the design process will also play an important role as both the approaches have pros and cons.

It is increasingly recognized that the design of the CRF (paper form/electronic form) is a key quality step in ensuring the data required by the protocol, regulatory compliance and/or safety needs/comments, study-specific hypothesis attributes, site work flow, and cross-checking of data items within a form or across different forms are addressed.[ 3 ] The CRF used in clinical research reduces messy clinical realities to round integers and categorical answers.[ 4 ]

This article is an attempt to describe the methods of CRF designing in clinical research, discusses the challenges encountered and measures to be taken to prevent the occurrence of issues in its development.

PAPER CASE REPORT FORM VERSUS ELECTRONIC CASE REPORT FORM

There are two types of CRFs used in clinical research, that is, traditional paper CRF and improvised electronic CRF (eCRF). Paper CRF is the traditional way of data capture and a better option if studies are small or vary in design, whereas eCRFs are considered if studies are large with similar designs.[ 5 ]

In the current global scenario, eCRFs are preferred over paper CRFs as they are less time-consuming, and also encourage the sponsor/pharmaceutical company to carry out large multicentric studies at the same time due to the ease of administration. It is designed in such a way that data entry can be done with zero/minimal errors. Moreover, the regulatory authorities are readily accepting submissions in which validated electronic data capture (EDC) systems are used.[ 6 ]

While designing an eCRF, repetitive data such as protocol ID, site code, subject ID, and patient initials will be generated by the system automatically from the first page to all others, thus ensuring no duplication of CRF pages.

In eCRF, linking the data between two related pages of CRFs becomes easy and quick. They have built-in edit checks tagged to each data field as well as to the CRF as a whole. Therefore, majority of data cleaning activities will take place during the completion of the eCRFs, thus reducing the time and effort required by data management personnel. Instant query resolution reduces the time spent on obtaining the clarification from the site/investigator and hence, clean data is obtained much quickly, resulting in timely database lock, faster regulatory submission, and subsequent approval.

Designing a paper CRF is a tedious job that could result in data errors and wrong conclusions, requiring meticulous attention to minimize duplication of CRF pages. Chances of error during data transfer from the source document to paper CRF are common. Moreover, for studies with large sample size if traditional method of data collection through paper CRFs is opted, then manual data cleaning may be a major concern. However, this method may not require user training and system validation as in the case of EDC systems, where such things are essential before implementing it. Despite their many advantages, eCRFs have not been accepted widely. Main reasons behind this are lack of available on-site technology, investigators’ lack of motivation, complexity of installation, and maintenance of the software and high investment cost.

STANDARD CASE REPORT FORM DESIGN

Designing a CRF is an art that should to be based on scientific practices and the design should be implemented keeping the end-user (the one who enters data in the CRF) in mind. While designing, all important sections of the CRF should be included with care; always it is worth to remember that insufficient/inaccurate data collection would prove expensive during analysis. Hence, it is advisable to have a standard operating procedure for CRF preparation and to follow best practices of CRF designing.

Primary objective of CRF designing is to gather complete and accurate data by avoiding duplication and facilitating transcription of data from source documents onto the CRF. CRF should be designed with the primary safety and efficacy endpoints as the main goal of data collection.[ 6 ] Ideally, it should be well-structured, easy to complete without much assistance and should collect data of the highest quality. Always minimum amount of data needed to answer the study hypotheses should be collected avoiding collection of elaborate, unimportant information. For ordinal data, to ensure uniformity and clarity among raters, adequate explanation should be provided adjacent to the CRF fields. Capturing the same piece of data in more than one place (duplication) on the CRF should also be avoided. In other words, CRF should collect data in sufficient detail without ambiguity and at the same time, should avoid redundancy and avoid capture of unwanted details. Hence, striking the perfect chords to ensure balance between effective data collection and structuring the CRF to support accurate data entry is essential. Collecting the data in the coded form whenever possible is ideal as it facilitates data entry (at CRF and at the database levels) and helps the statistician in data interpretation and analysis.

Important part of the CRF is an informative header and footer, which can be customized.[ 7 ] In general, the header includes protocol ID, site code, subject ID, and patient initials. Whereas, the footer includes investigator's signature, date of signature, version number, and page number.

In order to enhance easy reading/understanding and accurate data entry, an uncrowded CRF layout should be preferred. Placing too many details on the same page, makes the CRF look cluttered and makes data entry difficult, which eventually leads to increase in data discrepancies.

Case report form design should be standardized to address the needs of all those who handle the data such as investigator, data manager, biostatistician, clinical research monitor/coordinator, database developer/programmer and data entry personnel etc. An effective CRF design would always be user friendly. Moreover, it should capture legible, consistent and valid data, thereby, reducing query generations.[ 7 ] While designing the CRFs, design standards should be adhered to for improving the quality of data collected. Hence, data should be organized in a format that facilitates data analysis and makes it simplified.

The following points are to be borne in mind while designing a CRF:

• Use of consistent formats, font style and font sizes throughout the CRF booklet
• Selection of portrait versus landscape versus combination layouts
• Use of clear and concise questions, prompts, and instructions
• Visual cues, such as boxes that clearly indicate place and format of data to be recorded should be provided to the person recording the data as much as possible
• Using the option of “circling of answers” should be limited as it's hard to interpret; instead check boxes would be appropriate
• Clear guidance about skip patterns like what to skip and what not to skip should be mentioned at appropriate places
• Skips (are instructions provided in the CRF page to maintain the connectivity between pages) should be kept to a minimum by the placement of questions to avoid confusions
• Provide boxes or separate lines to hold the answers. This indirectly informs the data recorder where to write/enter the response and helps to differentiate it visually from the entry fields for other questions
• Separate the columns with thick lines
• Provide bold and italicized instructions
• Minimize free text responses
• Position only specified density of questions on each page
• Page numbering if necessary, should be consistent throughout
• Avoid using “check all that apply” as it forces assumptions about the clinical data
• Specify the unit of measurement
• Indicate the number of decimal places to be recorded
• Use standard data format (e.g., dd/mm/yyyy) throughout the CRF
• Use precoded answer sets such as yes/no, male/female, method of administration of medicine, and severity of adverse event (AE) (mild/moderate/severe) wherever possible
• Not to split modules/sections (a set of one or more related groups of questions that pertain to a single clinical study visit) like, for example, AE section should not be split and laid across pages such that information related to a single AE will have to be collected from different pages
• Use “no carbon required (NCR)” copies to ensure exact replica of CRF

A sample case report form (CRF) page. An adverse event page of CRF is depicted showing codes, and skips questions

WELL DESIGNED CASE REPORT FORM VERSUS POORLY DESIGNED CASE REPORT FORM

Table 1 provides the comparison between well-designed and poorly designed CRF. In case of poorly designed CRF, by placing a single line for required response results in variations in the investigator's responses from site to site. On the other hand, separate lines and boxes are provided in the well-designed form, which gives the visual cues about what is expected as a response and thereby, reduces the unnecessary queries. Usually, boxes are used for entering dates and the date format (i.e., dd/mm/yyyy) should be consistent on all pages of CRF. Units and decimal points should be displayed for vital sign records, which clarify the user about the expected values and also facilitates the data interpretation and reduces manipulation during analysis procedures. Figures ​ Figures2 2 and ​ and3 3 are examples of poorly designed CRFs. Poor CRF design results in frequent database modification thus affecting the study timelines. Data need to be collected in a way that does not introduce bias or errors. Collection of a large amount of data will result in wasted resources in collecting and processing it. Questions in the CRF should be clear and unambiguous to avoid unnecessary confusions.[ 8 ]

Illustrating a well-designed and poorly designed data fields imparting the significance of visual cues to help the site personnel to understand the format

Example of a poorly designed case report form

Illustrating the missing indicator question

In some circumstances, data can be obtained using derivation procedures; collection of derived data again on the CRF should be avoided to minimize calculation errors. For example, age can be calculated using date of birth. Body mass index can be calculated using height and weight of the subject, only the latter two should be captured.

In conditions where same parameters are to be recorded at multiple visits, it is recommended to use the same CRF module for each visit to reduce the number of query generation. For example, vital Signs and body systems in the physical examination (PE) module can be collected in the same order each time.

In some places, answers are coded in order to simplify the data collection. When codes are used to obtain an answer for a question, consistency in codes should be maintained throughout the CRF booklet and there should not be any variation in the answer for the same question.

For example, yes/no answers are coded as 1 = yes and 2 = no (preferred coding) as shown in Figure 4 . If the codes are assigned in this order, the same order should be practiced throughout the CRF. Nowhere in the same CRF “1” should be coded for “no” and “2” should be coded for “yes”.

Coding on the case report form module

Even the location of these codes on the CRF should be consistent; same is shown in Figure 4 . Clear instructions should be provided to the user where ever necessary; otherwise, it will have a significant impact on the data management activities like database designing, data cleaning, data validation, and data extraction due to poor understanding of the site personnel about the expected responses. It is advisable to use indicator questions wherever needed to avoid assumptions about the data. Use indicator questions in connection to a set of other questions, and the response to the indicator question would decide on whether the associated set of questions needs to be answered or not. For example, in an AE question group, an indicator question could be, “Did any AE occur after the last visit?”

If the response is “yes”, the remaining questions pertaining to the details of the AE(s) (such as severity, seriousness, causality, date of onset, date of resolution, and action taken) require responses. If the response is “no”, the rest of the question group is not answered. Incorporation of an indicator question and skips are shown in Figure 1 . Ideally, CRF booklet should have a chart reflecting the expected list of assessments as per schedule specified in the protocol.

STANDARD CASE REPORT FORM TEMPLATES

Some of the data requirements such as demography, PE, AEs are same across studies, so standard CRF templates should be developed which can be customized accordingly. These templates are of great help while conducting multiple studies in the same research area. These templates will have the same design principles that help the user to enter data with ease since the design is familiar to them; there is no need for special training on these modules of CRFs.

A “library” of standard templates should be established and maintained by the sponsor/contract research organizations, pharmaceutical companies in order to maintain uniformity in the CRF design and to save time. Most commonly used standard CRF templates are inclusion criteria, exclusion criteria, demography, medical history, PE, AE, concomitant medication and study outcome modules, whereas, the modules which captures efficacy data are not unique. Their design varies from study to study depending on the protocol specifications.

CASE REPORT FORM CONNECTIVITY/WELL REFERENCED CASE REPORT FORMS

Linking of CRF (paper CRF and eCRF) pages wherever necessary is known as CRF connectivity. Each CRF booklet is assigned with unique subject ID and it is the duty of site personnel to make sure that same ID is entered on all pages of CRF booklet. Consistently entered subject ID will help in tracking the missing CRF pages. The fields such as protocol ID, site code, subject ID, and patient initials make database designing easier and helps linking CRF pages to the study database. The fields like protocol ID and visit labels are informative features as they provide brief descriptions of the study and the schedule of assessments, respectively. The CRF version number is a critical field that prevents an incorrect CRF page being used. All pages of the CRF booklet should be numbered in sequential order, which will help in identifying queries through data validation procedures and manual reviews. Page numbering not only provides the site personnel with a quick reference to specific pages, but also helps to design the database in a structured manner. Especially, in case of eCRF, retrieving of CRFs becomes challenging if proper programming is not carried out. CRF connectivity is crucial when statistical analysis plan (SAP) is complex and these fields will be of help in statistical analysis.

CHALLENGES IN CASE REPORT FORM DESIGNING

Commonly encountered challenges in CRF designing are consistency in the design, collection of precise data and user-friendliness. These challenges can be overcome by proper planning by a team of data management personnel, biostatisticians, clinicians, and medical writers. Objectives should be defined clearly before designing. Consistent design is a crucial aspect as it reduces the number of mistakes in data entry. It is of great advantage when using them across various studies. Maintaining standard CRF templates would resolve this issue. Collection of extraneous data is another issue and measures should be taken to avoid it, as processing this becomes tedious. In such instances, ensuring accuracy and quality become major challenges. Attention should be paid to avoid duplication. Design the CRF to avoid referential and redundant data collection. For example, collecting calculated fields/derivable data should be avoided and to ensure that data collection is cost-effective. Designing user-friendly CRF to reduce data entry errors is again a challenge. Simple/standard designs should be incorporated wherever possible.

User feedback mechanism should be built into the CRF design and maintenance process. Best practices should be applied to improve the data quality and save time with CRF design. Providing CRF completion guideline aids in minimizing the challenges in data capture and data entry.

CASE REPORT FORM COMPLETION GUIDELINES

A CRF completion guideline is a document to assist the investigator to complete the CRF in a step by step manner and is drafted concurrently in line with the CRF and protocol. Figure 5 shows sample page of CRF completion guideline. There is no standard template for CRF completion guidelines as it is study specific. It should be prepared in such a way that it enables the site personnel to complete the CRFs with ease and legibility. CRF completion manual should provide clear instructions to site personnel for accurate completion of CRFs along with clear expectations including proper instructions on handling unknown data. For example, if exact date is unknown, then use a preferred notation in the place of missing value (i.e., UK/UNK/2012). The language used should be simple with clear instructions, concise, and easy to understand.

Sample page of case report form completion guideline

Case report form completion guidelines document, while bridging the gap between the study protocol and the data collection process, explains the activities involved in CRF completion, correction, signing, and data handling.[ 7 ] It provides unambiguous instructions on CRF completion in all practical scenarios. For example, if data were wrongly entered and the site personnel wants to correct it, the instruction provided would be to strike-through the incorrect data with a single line, put the initials (of the person who makes the change) with date and to write the correct entry in the margin against the corresponding line. Similarly, instructions will be provided for each data entry field on each page in the CRF booklet. This helps to ensure completion of all required data fields and enhances the data flow.[ 7 ] CRF completion guidelines could be a separate document or could be a part of the CRF booklet giving page by page instructions. If it is included as part of the CRF, it is advisable to print instructions on the page facing the CRF page (back side of the previous page) as the investigator can easily take instructions and simultaneously fill the CRF page. CRF completion guidelines document should have version control and amendments should be done as and when required.

Case report form design is the initial step in translating the protocol into standard questionnaires and is paramount to a successful clinical trial. Standard CRF should be designed in such a way that it helps the collection of consistent and valid data, ultimately resulting in submission of data to regulatory authorities and its acceptance. Regardless of the time and effort spent conducting the trial, the correct data points (response to a CRF question/data is entered) must be collected; otherwise, a meaningful analysis may not be possible. Therefore, a sound SAP should be used as a tool to develop and judge the adequacy of the CRF, which should be available to guide on what data points need to be captured on the CRF. To avoid future amendments, it is important to have design principles in mind well in advance before CRF designing is initiated. These standard guidelines will contribute in preparing a well-designed CRF for data acquisition.

ACKNOWLEDGMENT

We would like to acknowledge the technical support offered by Mr. Vinoth T. and Mr. Sagi Subbaraju that has helped us during the preparation of this article.

Source of Support: Nil.

Conflict of Interest: None declared.