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Institutional Review Board

Case report publication guidance: irb review and hipaa compliance.

Background:

Many journals now require a letter, or other acknowledgement, from an IRB prior to publication of a case report.  Specifically, they wish to know whether IRB approval was obtained or was not required for the described case.  The JHM IRBs have adopted a policy to address the following question and answers.

Q: What constitutes a “case report”?

A case report for IRB purposes is a retrospective analysis of one, two, or three clinical cases.  If more than three cases are involved in the analytical activity, the activity will constitute “research.”

Please review the JHM Organization Policy on Single Case Reports and Case Series (Policy No. 102.3) .

Q:  Do faculty who prepare a  case report as an article for submission to a journal require IRB approval prior to preparation?

No.  A case report is a medical/educational activity that does not meet the DHHS definition of “research”, which is: "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."  Therefore, the activity does not have to be reviewed by a JHM IRB.

Q: Can I request that the IRB make a formal determination that my case report is not research?

In certain cases, journals may require a formal determination from the IRB that a case report does not constitute research. Researchers seeking an official IRB determination that a case report is not research should submit a not-human subjects research (NHSR) application through the eIRB system. 

The following steps should be followed when submitting a request for a formal determination from the IRB:

• In Section 1, Item 7, select   “NHSR/QA” as the review type
• Upload a project description in Section 4. Your proposal should include a description of the process for the de-identification of data or in the alternative the process for obtaining HIPAA authorization from the patient(s) if Protected Health Information may be included. 

Q:  Are there HIPAA implications associated with publication of case reports?

Yes.  Under HIPAA, a case report is an activity to develop information to be shared for medical/educational purposes.  Although the use of protected health information to prepare the paper does not require IRB review, the author of a case report must comply with HIPAA.  Ideally, the author of the article will obtain the signed authorization of the subject, or the subject’s legally authorized representative if the subject is deceased, to use the subject’s information in the article.  If it is not possible to obtain authorization, the author should be aware that one of the identifiers described by HIPAA as requiring written authorization is, “Any other unique identifying number, characteristic, or code….”  Moreover, HIPAA requires that, at the time of publication, “[t]he covered entity does not have actual knowledge that the information could be used alone or in combination with other information to identify an individual who is a subject of the information.” (See: Definition of De-Identified Data .)   

• Authors who remove HIPAA identifiers (including unique patient characteristics) from the data prior to submission and publication of the article do not need to obtain a signed privacy authorization. 
• Investigators who wish to publish case report data with HIPAA identifiers will need to obtain from the patient a signed HIPAA compliant authorization.  This authorization does not need to be submitted to the IRB for review. The appropriate authorization form for use with a single case report may be found on the HIPAA web site HERE.
• If the author strips off all HIPAA identifiers, but the information associated with the subject of the article includes a “unique characteristic” which would make it identifiable to the subject, or the author has actual knowledge that the information about the subject could be used alone or in combination with other information to identify the subject, the author must contact the HIPAA Privacy Officer to discuss the required steps to take prior to publication.  

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• Writing a case report...

Writing a case report in 10 steps

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• Peer review
• Victoria Stokes , foundation year 2 doctor, trauma and orthopaedics, Basildon Hospital ,
• Caroline Fertleman , paediatrics consultant, The Whittington Hospital NHS Trust
• victoria.stokes1{at}nhs.net

Victoria Stokes and Caroline Fertleman explain how to turn an interesting case or unusual presentation into an educational report

It is common practice in medicine that when we come across an interesting case with an unusual presentation or a surprise twist, we must tell the rest of the medical world. This is how we continue our lifelong learning and aid faster diagnosis and treatment for patients.

It usually falls to the junior to write up the case, so here are a few simple tips to get you started.

First steps

Begin by sitting down with your medical team to discuss the interesting aspects of the case and the learning points to highlight. Ideally, a registrar or middle grade will mentor you and give you guidance. Another junior doctor or medical student may also be keen to be involved. Allocate jobs to split the workload, set a deadline and work timeframe, and discuss the order in which the authors will be listed. All listed authors should contribute substantially, with the person doing most of the work put first and the guarantor (usually the most senior team member) at the end.

Getting consent

Gain permission and written consent to write up the case from the patient or parents, if your patient is a child, and keep a copy because you will need it later for submission to journals.

Information gathering

Gather all the information from the medical notes and the hospital’s electronic systems, including copies of blood results and imaging, as medical notes often disappear when the patient is discharged and are notoriously difficult to find again. Remember to anonymise the data according to your local hospital policy.

Write up the case emphasising the interesting points of the presentation, investigations leading to diagnosis, and management of the disease/pathology. Get input on the case from all members of the team, highlighting their involvement. Also include the prognosis of the patient, if known, as the reader will want to know the outcome.

Coming up with a title

Discuss a title with your supervisor and other members of the team, as this provides the focus for your article. The title should be concise and interesting but should also enable people to find it in medical literature search engines. Also think about how you will present your case study—for example, a poster presentation or scientific paper—and consider potential journals or conferences, as you may need to write in a particular style or format.

Background research

Research the disease/pathology that is the focus of your article and write a background paragraph or two, highlighting the relevance of your case report in relation to this. If you are struggling, seek the opinion of a specialist who may know of relevant articles or texts. Another good resource is your hospital library, where staff are often more than happy to help with literature searches.

How your case is different

Move on to explore how the case presented differently to the admitting team. Alternatively, if your report is focused on management, explore the difficulties the team came across and alternative options for treatment.

Finish by explaining why your case report adds to the medical literature and highlight any learning points.

Writing an abstract

The abstract should be no longer than 100-200 words and should highlight all your key points concisely. This can be harder than writing the full article and needs special care as it will be used to judge whether your case is accepted for presentation or publication.

Discuss with your supervisor or team about options for presenting or publishing your case report. At the very least, you should present your article locally within a departmental or team meeting or at a hospital grand round. Well done!

Competing interests: We have read and understood BMJ’s policy on declaration of interests and declare that we have no competing interests.

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Clinical Case Reports

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Learn how to identifiy an appropriate case, conduct a literature search, identify a target journal, and write a clinical case report.

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Ask an editor to review your case report, ask a question.

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Writing Clinical Case Reports

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Finding Case Reports

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Finding journals that publish case reports

Before you get started, why should i write a case report.

Although case reports are not the most robust form of medical evidence, they serve an important purpose: sharing knowledge among clinicians. Case reports also provide more timely reporting than larger and lengthier studies, making them useful for alerting the medical community to emerging diseases and previously unobserved adverse effects of treatment. Case reports can identify knowledge gaps that should be addressed by future clinical and basic science research. Finally, writing a case report provides an opportunity to develop your writing and publishing experience.

What kinds of cases are publishable?

Authors often assume that a publishable case must be entirely unique, but that’s not necessarily so. Instead, journals are mainly interested in cases that have educational value to other clinicians. When selecting a case, consider the following topics:

• Previously undescribed diseases or syndromes
• Uncommon or new presentations of a disease
• Beneficial, adverse, or unexpected responses to treatment
• Unusual combinations of symptoms, test results, or events that make diagnosis or treatment challenging
• New uses for existing therapies
• Use of imaging, pathologic, genetic, or a new technology to resolve a diagnostic dilemma
• Findings that shed new light on the possible pathogenesis of a disease
• Identification of gaps, deficiencies, or inequities in the health care system

An essential step in deciding whether to write a case report is to perform a thorough literature search to determine whether the case will reveal something useful to others about patient management and clinical decision making. Ask for help with your literature search .

How do I choose a journal for my case report?

Review the author instructions as well as recent issues of journals in which you would like to publish to find out what kinds of case reports, if any, those journals publish. Keep in mind that some journals publish cases in forms other than the common Introduction-Case Description-Discussion format described below, including letters to the editor, brief reports, clinical quizzes, or analyses of images.

Are there guidelines for writing case reports?

The CARE (CAse Report) guidelines are reporting standards for clinical case reports. This 13-item checklist was designed to improve the transparency and accuracy of case reports. Many journals require use of the CARE checklist. Even if your target journal does not require CARE, consulting the checklist is very useful before you start to write so that you can collect all the necessary information and organize your writing.

How do I refer to the patient?

The patient should be referred to throughout the article as “the patient” or as “he” or “she” and never as “the case.” (It is fine to say, “We report the case of a patient with...”) The patient’s name, initials, or medical record number should never be mentioned (and such identifiers should be deleted from radiologic images or other figures used to illustrate the case).

How do I ensure patient privacy?

As stipulated in the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA), authors must obtain—and sufficiently document—permission to publish protected health information (PHI), which is patient health information paired with patient-identifying information. To de-identify PHI, HIPAA requires the removal of all uniquely identifying patient characteristics.

In many instances, such as in reports of retrospective studies, PHI can be sufficiently de-identified to leave only the relevant health information, which can be published without permission and without violating patient privacy. But in case reports, which often describe the history, symptoms, diagnoses, treatments, and outcomes of a single person, even removing the names, medical record numbers, and other identifiers may be insufficient to safeguard patient identity.

Even for case reports that do not include PHI, a signed HIPAA Authorization should be obtained if there is any chance that the patient or the patient’s family members or friends could recognize the patient if they read the case report.

Secure the correct permissions

Institutional policy requires that the consent of the patient or his or her family be obtained before a case report can be published. Often, the journal will supply a form to document the patient’s permission to publish the case. If no form is available from the journal internal forms can be used instead (see below). These forms are used to document the patient’s (or legally authorized representative’s) consent to publication of such material.

If your case report includes any personally identifiable images, such as photographs, radiologic images, or videos of the patient, institutional policy requires both a HIPAA Authorization form and a Media Authorization and Release form.

Both the HIPAA Authorization form for educational publications and the Media Authorization and Release form can be found in Forms on Demand.

Privacy resources

• Patient Privacy: Uses and Disclosures of Protected Health Information ( MD Anderson Institutional Policy #ADM0401 )
• Policy Regarding Use of Institutional Images ( MD Anderson Institutional Policy #ADM1050 )
• Patient Privacy – De-identification of Protected Health Information (PHI) ( MD Anderson Institutional Policy #1180 )
• Find more policies and procedures related to HIPAA & Privacy

Introduction Section

The Introduction section of your case report should briefly establish the rationale for reporting the case, including its importance. For example, you might establish that a condition is unique or rare while relating it to conditions that other physicians might see more often in practice. At the end of the Introduction, you should include 1 or more sentences on the purpose of the case report. These sentences should indicate why the case is being reported and how it contributes to medical knowledge (in other words, what readers will gain by reading about it).

The following example does these things well:

Although peripheral arthritis is the most common extraintestinal manifestation of inflammatory bowel disease, it is very rarely addressed in the orthopaedic literature. The overwhelming majority of patients with inflammatory bowel disease present with gastrointestinal symptoms and do not have any joint involvement until much later. We present the case of a patient who had joint pain and swelling but lacked any sign of gastrointestinal involvement. After 5 months of workup, the patient was diagnosed with Crohn disease, and the joint symptoms improved with appropriate medical treatment. We believe that inflammatory bowel disease should be considered in the differential diagnosis of joint pain and swelling. (From Olszewski MA et al. Knee pain and swelling due to Crohn disease. J Bone Joint Surg Am 87:1844–1847, 2005.)

This Introduction begins by talking about conditions that are commonly seen in medical practice, indicates that the case described was extremely unusual (why it is being reported), and encourages physicians to consider Crohn disease in patients who present with joint swelling (how the case contributes to medical knowledge).

Sometimes references are needed to explain why a case is being reported. If appropriate, you can cite review articles instead of individual cases or studies to minimize the number of references. (Many journals have strict limits on the number of references permitted in case reports.)

Case Description

The next section is a description of the case being reported. This section is typically labeled “Case Report,” “Case History,” or “Case Description” (depending on journal style).

The Case Description section should tell a story. You should include all relevant data to enable readers to understand the case and understand how you reached the diagnoses and treatment decisions, but you should omit details not directly relevant to the decisions or outcomes.

The case is usually presented in chronological order. It is important to keep the time frame clear for readers, especially if the case starts with referral to our institution and then requires a jump back in time to events that happened earlier. If the patient was treated at multiple institutions, you should make clear what was done at our institution.

• Presenting signs, symptoms, and complaints;
• Relevant medical history and relevant family medical history;
• Other personal history relevant to the case (for example, tobacco use in a patient with lung cancer);
• Medications being used;
• Relevant results of physical examinations, laboratory tests (include normal range for unusual tests), and radiologic imaging;
• Considerations during the differential diagnosis, preliminary diagnosis if different from final diagnosis, and any tests and treatments prompted by the preliminary diagnosis;
• Final diagnosis and how it was determined;
• Treatments;
• Follow-up to present.

If the case requires reporting many data, a table may be an efficient way to present those data.

Cases that focus on histopathologic findings, results of specialized laboratory studies, and/or genetic findings may need separate sections for those findings (such sections typically appear after the Case Description section or as subsections of the Case Description section) or even separate Methods and Results sections if the tests are unusual or uncommon.

Discussion Section

The Discussion section interprets the case for readers, supports the validity of your diagnoses and interpretations, and states the implications of the case. If you claim that your case is the first such case reported, you should also describe your literature search in this section (including what languages of publications you considered). [Note: It is always safest to add “to our knowledge” to any claim of being first.]

If other related cases have been reported, you should indicate in the Discussion how they are similar to and different from your case.

The Discussion is where you convince readers that your diagnosis or interpretations are correct and show that you considered other possibilities. If applicable, you should briefly discuss the differential diagnosis, including how you know your diagnosis is the correct one and why other possible diagnoses were rejected. You should always be sure to address any evidence that contradicts your diagnosis or interpretations.

The Discussion should also make clear your take-home message for readers. What should they consider doing differently as a result of reading this case (for example, when encountering a particular set of symptoms and test results in a particular patient setting, should they consider an additional diagnosis or a new treatment)? Or what shift in medical or scientific knowledge is suggested by this case, and what is the next step in advancing that knowledge?

Many journals require a brief abstract for each case report. The Abstract of a case report is usually unstructured (that is, contains no subheadings) and consists of 1 short paragraph. The Abstract should summarize the key points in the case, including the purpose (from the Introduction), unique features, final diagnosis, treatment, outcome (all from the Case Description), and take-home message of the case (from the Discussion). The Abstract should not include statements such as “X will be described” or “Y will be discussed”; these are not helpful to people reading your Abstract online.

Bibliography

Huth EJ. Writing and Publishing in Medicine , 3rd ed. (Philadelphia: Lippincot Williams & Wilkins, 1999).

Iles RL. Guidebook to Better Medical Writing . Olathe, KS, Island Press, 2004. Buckingham TA. Publication of case reports. Writing Medical and Scientific Papers 2(2):3–4, 2000 (electronic newsletter formerly available at http://www.lifescipub.com/vol2_no2.htm; accessed July 13, 2005).

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Library by the Numbers

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• Open access
• Published: 06 April 2016

How to review a case report

• Rakesh Garg 1 ,
• Shaheen E. Lakhan 2 &
• Ananda K. Dhanasekaran 3  

Journal of Medical Case Reports volume  10 , Article number:  88 ( 2016 ) Cite this article

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Peer Review reports

Introduction

Sharing individual patient experiences with clinical colleagues is an essential component of learning from each other. This sharing of information may be made global by reporting in a scientific journal. In medicine, patient management decisions are generally based on the evidence available for use of a particular investigation or technology [ 1 ]. The hierarchical rank of the evidence signifies the probability of bias. The higher up the hierarchy, the better its reliability and thus its clinical acceptance (Table  1 ). Though case reports remain lowest in the hierarchy of evidence, with meta-analysis representing the highest level, they nevertheless constitute important information with regard to rare events and may be considered as anecdotal evidence [ 2 ] (Table  1 ). Case reports may stimulate the generation of new hypotheses, and thus may support the emergence of new research.

The definition of a case report or a case series is not well defined in the literature and has been defined variously by different journals and authors. However, the basic definition of a case report is the detailed report of an individual including aspects like exposure, symptoms, signs, intervention, and outcome. It has been suggested that a report with more than four cases be called a case series and those with fewer than four a case report [ 3 ]. A case series is descriptive in design. Other authors describe “a collection of patients” as a case series and “a few patients” as a case report [ 4 ]. We suggest that should more than one case be reported, it may be defined as a case series—a concept proposed by other authors [ 5 ].

The importance of case reports

A case report may describe an unusual etiology, an unusual or unknown disorder, a challenging differential diagnosis, an unusual setting for care, information that can not be reproduced due to ethical reasons, unusual or puzzling clinical features, improved or unique technical procedures, unusual interactions, rare or novel adverse reactions to care, or new insight into the pathogenesis of disease [ 6 , 7 ]. In recent years, the publication of case reports has been given low priority by many high impact factor journals. However, the need for reporting such events remains. There are some journals dedicated purely to case reports, such as the Journal of Medical Case Reports , emphasizing their importance in modern literature. In the past, isolated case reports have led to significant advancements in patient care. For example, case reports concerning pulmonary hypertension and anorexic agents led to further trials and the identification of the mechanism and risk factors associated with these agents [ 2 , 8 ].

Reporting and publishing requirements

The reporting of cases varies for different journals. The authors need to follow the instructions for the intended publication. Owing to significant variability, it would be difficult to have uniform publication guidelines for case reports. A checklist called the CARE guidelines is useful for authors writing case reports [ 9 , 10 ]. However, it would be universally prudent to include a title, keywords, abstract, introduction, patient information, clinical findings, timeline, diagnostic assessment, therapeutic interventions, follow-up and outcomes, discussion, patient perspective, and informed consent.

Peer review process

The peer review process is an essential part of ethical and scientific writing. Peer review ultimately helps improve articles by providing valuable feedback to the author and helps editors make a decision regarding publication. The peer reviewer should provide unbiased, constructive feedback regarding the manuscript. They may also highlight the strengths and weaknesses of the report. When reviewing an article, it is prudent to read the entire manuscript first to understand the overall content and message. The reviewer than may read section-wise and provide comments to the authors and editorial team accordingly. The reviewer needs to consider the following important points when reviewing a case for possible publication [ 8 , 9 ] (summarized in Table  2 ).

Novelty remains the foremost important aspect of a case. The case report should introduce novel aspects of patient evaluation, investigation, treatment, or any other aspect related to patient care. The relevant information becomes a hypothesis generator for further study. The novelty may at times be balanced with some important information like severe adverse effects, even if they have been reported earlier. Reporting adverse events remains important so that information on cumulative adverse effects can be gathered globally, which helps in preparing a policy or guideline or a warning note for its use in patients. The data related to adverse effects include not only the impact but also the number of patients affected. This becomes more important for serious adverse effects. In the absence of an international registry for adverse effects, published case reports are important pieces of information. Owing to ethical concerns, formal evaluation may not be feasible in the format of prospective study.

Essential description

The case needs to have all essential details to allow a useful conclusion to emerge. For example, if a case is being reported for hemodynamic variability due to a drug, then the drug dose and timing along with timed vital signs need to be described.

Authenticity and genuineness

Honesty remains the most important basic principle of all publications. This remains a primary responsibility of the authors. However, if there is any doubt, reviewers may seek clarification. This doubt may result from some discordance in the case description. At times, a lack of correlation between the figures and description may act as “red flags.” For instance, authors may discuss a technique for dealing with a difficult airway, but the figure is of a normal-appearing airway. Another example would be where the data and figure do not correlate in a hemodynamic response related to a drug or a technique, with the graphical picture or screenshot of hemodynamics acting as an alert sign. Such cause for concern may be communicated in confidence to the editor.

Ethical or competing interests

Ethical issues need to be cautiously interpreted and communicated. The unethical use of a drug or device is not desirable and often unworthy of publication. This may relate to the route or dose of the drug administered. The off-label use of drugs where known side effects are greater than potential benefit needs to be discouraged and remains an example of unethical use. This use may be related to the drug dose, particularly when the drug dose exceeds the routine recommended dose, or to the route of administration. As an example, the maximal dose of acetaminophen (paracetamol) is 4g/day, and if an author reports exceeding this dose, it should be noted why a greater than recommended dose was used. Ultimately, the use of a drug or its route of administration needs to be justified in the manuscript. The reviewers need to serve as content experts regarding the drugs and other technologies used in the case. A literature search by the reviewer provides the data to comment on this aspect.

Competing interests (or conflicts of interest) are concerns that interfere or potentially interfere with presentation, review, or publication. They must be declared by the authors. Conflicts can relate to patient-related professional attributes (like the use of a particular procedure, drug, or instrument) being affected by some secondary gains (financial, non-financial, professional, personal). Financial conflict may be related to ownership, paid consultancy, patents, grants, honoraria, and gifts. Non-financial conflicts may be related to memberships, relationships, appearance as an expert witness, or personal convictions. At times, the conflict may be related to the author’s relationship with an organization or another person. A conflict may influence the interpretation of the outcome in an inappropriate and unscientific manner. Although conflicts may not be totally abolished, they must be disclosed when they reasonably exist. This disclosure should include information such as funding sources, present membership, and patents pending. Reviewers should cautiously interpret any potential bias regarding the outcome of the case based on the reported conflicts. This is essential for transparent reporting of research. At times, competing interests may be discovered by a reviewer and should be included in comments to the editorial team. Such conflicts may again be ascertained when the reviewer reviews the literature during the peer review process. The reviewer should also disclose their own conflicts related to the manuscript review when sending their report to the editorial team.

Impact on clinical practice

This is an important aspect for the final decision of whether to publish a case report. The main thrust or carry-home message needs to be emphasized clearly. It needs to be elaborated upon in concluding remarks.

Patient anonymity, consent, and ethical approval

When reviewing the manuscript of a case report, reviewers should ensure that the patient’s anonymity and confidentiality is protected. The reviewers should check that patient identifiers have been removed or masked from all aspects of the manuscript, whether in writing or within photograph. Identifiers can include things like the name of the patient, geographical location, date of birth, phone numbers, email of the patient, medical record numbers, or biometric identifiers. Utmost care needs to be taken to provide full anonymity for the patient.

Consent is required to participate in research, receive a certain treatment, and publish identifiable details. These consents are for different purposes and need to be explained separately to the patient. A patient’s consent to participate in the research or for use of the drug may not extend to consent for publication. All these aspects of consent must be explained to the patient, written explicitly in the patient’s own language, understood by the patient, and signed by the patient. For the purpose of the case, the patient must understand and consent for any new technique or drug (its dose, route, and timing) being used. In the case of a drug being used for a non-standard indication or route, consent for use must also be described. Patient consent is essential for the publication of a case if patient body parts are displayed in the article. This also includes any identifiers that can reveal the identity of the patient, such as the patient’s hospital identification number, address, and any other unique identifier. In situations where revealing the patient’s identity cannot be fully avoided, for example if the report requires an image of an identifiable body part like the face, then this should be explained to the patient, the image shown to them, and consent taken. Should the patient die, then consent must be obtained from next of kin or legal representative.

With case series, securing individual patient consent is advised and preferable. The authors may also need institutional review board (IRB) approval to publish a case series. IRBs can waive the need for consent if a study is conducted retrospectively and data are collected from patient notes for the purpose of research, usually in an anonymized way. However, wherever possible, individual patient consent is preferable, even for a retrospective study. Consent is mandatory for any prospective data collection for the purpose of publication as a case series. Consent and/or IRB approval must be disclosed in the case report and reasons for not obtaining individual consent may be described, if applicable.

There may be situations in which publishing patient details without their consent is justified, but this is a decision that should be made by the journal editor, who may decide to discuss the case with the Committee on Publication Ethics. Reviewers need to emphasize the issue to the editor when submitting their comments.

Manuscript writing

The CARE guidelines provide a framework that supports transparency and accuracy in the publication of case reports and the reporting of information from patient encounters. The acronym CARE was created from CA (the first two letters in “case”) and RE (the first two letters in “reports”). The initial CARE tools are the CARE checklist and the Case Report Writing Templates. These tools support the writing of case reports and provide data that inform clinical practice guidelines and provide early signals of effectiveness, harms, and cost [ 10 ].

The presentation of the case and its interpretation should be comprehensive and related. The various components of the manuscript should have sufficient information for understanding the key message of the case. The reviewer needs to comment on the relevant components of the manuscript. The reviewer should ascertain that the title of the case manuscript is relevant and includes keywords related to the case. The title should be short, descriptive, and interesting. The abstract should be brief, without any abbreviations, and include keywords. It is preferable to use Medical Subject Headings (MeSH) keywords. Reviewers must ensure that the introduction emphasizes the context of the case and describes the relevance and its importance in a concise and comprehensive manner. The case description should be complete and should follow basic rules of medical communication. The details regarding patient history, physical examination, investigations, differential diagnosis, management, and outcome should be described in chronological order. If repeated observations are present, then they may be tabulated. The use of graphs and figures helps the readers to better understand the case. Interpretation or inferences based on the outcomes should be avoided in this section and should be considered a part of the discussion. The discussion should highlight important aspects of the case, with its interpretation within the context of the available literature. References should be formatted as per the journal style. They should be complete and preferably of recent publications.

Reviewer responsibility

The reviewer’s remarks are essential not only for the editorial team but also for authors. A good peer review requires honesty, sincerity, and punctuality. Even if a manuscript is rejected, the authors should receive learning points from peer review commentary. The best way to review a manuscript is to read the manuscript in full for a gross overview and develop general comments. Thereafter, the reviewer should address each section of the manuscript separately and precisely. This may be done after a literature search if the reviewer needs to substantiate his/her commentary.

Constructive criticism

The reviewer’s remarks should be constructive to help the authors improve the manuscript for further consideration. If the manuscript is rejected, the authors should have a clear indication for the rejection. The remarks may be grouped as major and minor comments. Major comments likely suggest changes to the whole presentation, changing the primary aim of the case report, or adding images. Minor comments may include grammatical errors or getting references for a statement. The editorial team must be able to justify their decision on whether or not to accept an article for publication, often by citing peer review feedback. It is also good style to tabulate a list of the strengths and weaknesses of the manuscript.

Fixed time for review

Reviewer remarks should be submitted within a specified timeframe. If any delay is expected, it should be communicated to the editorial team. Reviewers should not rush to submit feedback without sufficient time to adequately review the paper and perform any necessary literature searches. Should a reviewer be unable to submit the review within the specified timeframe, they should reply to the review invitation to decline at their earliest convenience. If, after accepting a review invitation, the reviewer realizes they do not have time to perform the review, this must be communicated to the editorial team.

Conflict of interest

The reviewer’s conflicts of interest should be included along with the review. The conflicts may be related to the contents of the case, drugs, or devices pertaining to the case; the author(s); or the affiliated institution(s) of the author(s).

Lack of expertise

The reviewer may decline to review the manuscript if they think the topic is out of their area of expertise. If, after accepting an invitation to review, the reviewer realizes they are unable to review the manuscript owing to a lack of expertise in that particular field, they should disclose the fact to the editorial team.

Confidentiality

The reviewer should keep the manuscript confidential and should not use the contents of the unpublished manuscript in any form. Discussing the manuscript among colleagues or any scientific forum or meetings is inappropriate.

Review of revised manuscript

At times, a manuscript is sent for re-review to the reviewer. The reviewer should read the revised manuscript, the author’s response to the previous round of peer review, and the editorial comments. Sometimes, the authors may disagree with the reviewer’s remarks. This issue needs to be elaborated on and communicated with the editor. The reviewer should support their views with appropriate literature references. If the authors justify their reason for disagreeing with the viewer, then their argument should be considered evidence-based. However, if the reviewer still requests the revision, this may be politely communicated to the author and editor with justification for the same. In response to reviewers remarks, authors may not agree fully and provide certain suggestion in the form of clarification related to reviewers remarks. The reviewers should take these clarifications judiciously and comment accordingly with the intent of improving the manuscript further.

Peer reviewers have a significant role in the dissemination of scientific literature. They act as gatekeepers for science before it is released to society. Their sincerity and dedication is paramount to the success of any journal. The reviewers should follow a scientific and justifiable methodology for reviewing a case report for possible publication. Their comments should be constructive for the overall improvement of the manuscript and aid the editorial team in making a decision on publication. We hope this article will help reviewers to perform their important role in the best way possible. We send our best wishes to the reviewer community and, for those who are inspired to become reviewers after reading this article, our warm welcome to the reviewers’ club.

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Rakesh Garg

Neurology and Medical Education, California University of Science and Medicine - School of Medicine, Colton, CA, USA

Shaheen E. Lakhan

Sandwell & West Birmingham Hospitals, NHS Trust, Birmingham, UK

Ananda K. Dhanasekaran

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Garg, R., Lakhan, S.E. & Dhanasekaran, A.K. How to review a case report. J Med Case Reports 10 , 88 (2016). https://doi.org/10.1186/s13256-016-0853-3

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Received : 27 August 2015

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DOI : https://doi.org/10.1186/s13256-016-0853-3

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How to write case reports

Oliver Kurzai

Adilia Warris

About this video

Case reports provide valuable information by throwing light on rare and unusual clinical presentations, symptoms or diseases. They show doctors how fellow practitioners have acted in similar situations and thus aid in the decision-making process by sharing best practices. 

The importance of case reports is resonated in the number of high-quality journals solely devoted to publishing case reports. However, the publication of the case reports is highly dependent on the contribution they make and their quality.

In this webinar, two editors of Medical Mycology Case Reports journal provide a guide to writing case reports and encourage you to summarize your clinical experiences while getting a publication in the process. You will come away with the knowledge of setting up and writing a case report, ethical issues to be considered before the publication and how to select an appropriate journal to publish your case report.

About the presenters

Prof. Oliver Kurzai, M.D, University of Würzburg, Germany, Editor in Chief, Medical Mycology Case Reports

Prof. Oliver Kurzai is Chair for Medical Microbiology and Mycology at the University of Würzburg. He holds an MD with a specialist recognition for microbiology, virology and infection epidemiology. His clinical focus is the diagnosis of fungal infections in the immuno-compromised host. Together with his team of scientists he addresses fundamental principles of invasive fungal infections with a focus on understanding the immunobiology of these infections and identifying new diagnostic targets. He is head of the German National Reference Center for Invasive Fungal Infections (NRZMyk) and serves as Editor in Chief of Medical Mycology Case Reports on behalf of the International Society for Human and Animal Mycology (ISHAM).

Professor MRC Centre for Medical Mycology

Prof Warris is a paediatric infectious diseases specialist with a specific interest in medical mycology. She is co-director of the MRC Centre for Medical Mycology at the University of Aberdeen. Prof Warris’ research profile has a strong translational focus and specific areas of interest include the host-fungus interaction in specific patient groups, the development of new management strategies for invasive fungal disease, paediatric antifungal stewardship and the epidemiology of fungal infections in children. Prof Warris chairs the European Paediatric Mycology Network (EPMyN).

Starting your case: A seven point checklist for writing your case report

Case reports webinar slides, get noticed - factsheet.

CARE GUIDELINES

The CARE guidelines: consensus-based clinical case report guideline development

• HRP Staff Directory
• Office Hours
• Quality Improvement Project vs. Research
• Self Exempt & UROP

Case Reports

• Commercial IRB Reliance Agreements
• National Cancer Institute Central IRB (CIRB) Independent Review Process
• UCI as the Reviewing IRB
• Submitting the Application
• Lead Researcher Eligibility
• Training & Education
• Ethical Guidelines, Regulations and Statutes
• Other Institutional Requirements
• Department of Defense Research Requirements
• Levels of Review
• Data Security
• Protected Health Information (HIPAA)
• European Union General Data Protection Regulation (EU GDPR)
• China’s Personal Information Protection Law
• Required Elements of Informed Consent
• Drafting the Informed Consent Form
• Consent and Non-English or Disabled Subjects
• Use Of Surrogate Consent In Research
• Vulnerable Populations
• Data and Safety Monitoring for Clinical Research
• Placebo-Controlled Studies
• Expanded Access to Unapproved Drugs or Biologics
• Right to Try: Unapproved Drugs or Biologics
• Use of Controlled Substances
• Expanded Access to Unapproved Medical Devices
• Humanitarian Use Devices
• Human Gene Transfer Research
• How To Register and Update Your Study
• Post-Review Responsibilities

Case Reports typically involve retrospective medical record reviews (of three or less patients ) and the only interaction with the patient has been for purposes of treating the patient, and not for the purpose of gathering research data. Case reports or case series of three or less individuals are not considered Human Subject's Research therefore UCI IRB review is not required. However an Administrative Self-Determination of Non-Human Subject's Research is required to be submitted via Kuali Research (KR) Protocols . The UCI IRB will not review or approve the submission . Activities may begin once the self-determination form is completed and submitted.

Per UCI HRP Policy #2 , a case series involving access to more than three patient medical records or case reports requires submission for IRB review

Defining a case report.

Often, Case Report activity involves sharing medical knowledge, improving quality, and providing education, and therefore will fall under the HIPAA definition of health care operations (45 CFR 164.501) , which includes:

• "Conducting quality assessment and improvement activities, including outcomes evaluation and development of clinical guidelines, provided that the obtaining of generalizable knowledge is not the primary purpose of any studies resulting from such activities; population-based activities relating to improving health or reducing health care costs, [and] protocol development.... and
• Reviewing the competence or qualifications of health care professionals, evaluating practitioner and provider performance, health plan performance, conducting training programs in which students, trainees, or practitioners in areas of health care learn under supervision to practice or improve their skills as health care providers, training of non-health care professionals, accreditation, certification, licensing, or credentialing activities."

PHI may be used within the covered entity for the purpose of preparing a case report without obtaining a HIPAA Authorization.   Often, a case report will be presented or published outside of the covered entity.  If the case report does not contain any of the 18 identifiers that cause medical information to be considered PHI under HIPAA, the case report is considered de-identified, and its presentation or publication does not require a HIPAA authorization.  If the case report contains PHI, then a HIPAA authorization would be required in order for it to be presented or published outisde of the covered entity.

• Health Care Privacy Compliance Handbook, published by Health Care Compliance Association, 2011, Chapter 4, pages 49-50.
• Institutional Review Board Management and Function, 2nd edition, 2006, Chapter 4-3, pages 103-104.

Conducting a Case Report

If an activity meets the definition of a Case Report, UCI faculty/resident should complete a request for non human subject research determination in via Kuali Research (KR) Protocols .

• Journals and science conference venues will generally inquire if an IRB review occurred for the Case Report activity
• UCI faculty/resident should retain the IRB-signed Request for Determination of Non-Human Subjects Research form (indefinitely) in the event that a journal (or, a Public Request Act/PRA, or external audit) request occurs

A HIPAA Authorization from the subject(s) of the Case Report is NOT required if there is access to PHI however there is no disclosure of PHI (outside of the covered/hybrid entity) in the Case Report publication.

A HIPAA Authorization from the subject(s) of the Case Report is required if there is disclosure of PHI outside of the covered/hybrid entity in the Case Report publication.  ( Disclosure of photos, even if de-identified, would require an Authorization Form. )

Use this HIPAA Authorization Form :

• Section “Release Records To”:   indicate the UCI faculty/resident name , and include the caveat “to be further disclosed in a Case Report publication
• Section “Purpose”:  indicate “Case Report publication”

The signed HIPAA Authorization Form should be uploaded and maintained in the patient's record.  At the time of signing the Authorization Form, the patient has the right to ask for a copy of the signed Authorization Form.

HIPAA Authorization Forms are located here (under "HIPAA Forms"): https://research.uci.edu/human-research-protections/research-subjects/privacy-and-confidentiality/protected-health-information-hipaa/

Translated HIPAA Authorization Forms are located here (under "Foreign Language Translations"): https://research.uci.edu/human-research-protections/irb-forms/

A list of PHI data elements: https://research.uci.edu/human-research-protections/research-subjects/privacy-and-confidentiality/protected-health-information-hipaa/#phi-ids

Death Data and Records

If the Case Report involves access, use, and disclosure of data from death records, the above described process would be similar (i.e., Request for Determination of Non-Human Subjects Research, Authorization Form ).

For death data/records accessed through the UCI Medical Center:

• If there is no disclosure of PHI in the Case Report publication, a HIPAA Authorization is not required .
• A HIPAA Authorization Form  from the legally authorized representative of the deceased patient  is required if there is disclosure of PHI outside the covered/hybrid entity in the Case Report publication.  (Follow the above "PROCESS")

For death data/records accessed publicly through CDPH:

• Reach out to the CDPH IRB to inquire if an IRB review would be required (when there is no disclosure of PHI, and when there is disclosure of PHI):  https://www.cdph.ca.gov/Programs/CHSI/Pages/Committee-for-the-Protection-of-Human-Subjects.aspx
• 2005 UCOP Fact Sheet  on SB 13
• California State CPHS:  https://www.chhs.ca.gov/cphs/https://oshpd.ca.gov/data-and-reports/data-resources/cphs/

Writing a Case Report

This page is intended for medical students, residents or others who do not have much experience with case reports, but are planning on writing one.  

What is a case report?  A medical case report, also known as a case study, is a detailed description of a clinical encounter with a patient.  The most important aspect of a case report, i.e. the reason you would go to the trouble of writing one, is that the case is sufficiently unique, rare or interesting such that other medical professionals will learn something from it.   

Case reports are commonly of the following categories :

- Rare diseases

- Unusual presentation of disease

- Unexpected events

- Unusual combination of diseases or conditions

- Difficult or inconclusive diagnosis

- Treatment or management challenges

- Personal impact

- Observations that shed new light on a disease or condition

- Anatomical variations

It is important that you recognize what is unique or interesting about your case, and this must be described clearly in the case report.

Case reports generally take the format of :

1. Background

2. Case presentation

3. Observations and investigation

4. Diagnosis

5. Treatment

7. Discussion

Does a case report require IRB approval?

Case reports typically discuss a single patient. If this is true for your case report, then it most likely does not require IRB approval because it not considered research.    If you have more than one patient, your study could qualify as a Case Series, which would require IRB review.  If you have questions, you chould check your local IRB's guidelines on reviewing case reports.

Are there other rules for writing a case report?

First, you will be collecting protected health information, thus HIPAA applies to case reports.   Spectrum Health has created a very helpful guidance document for case reports, which you can see here:   Case Report Guidance - Spectrum Health

While this guidance document was created by Spectrum Health, the rules and regulations outlined could apply to any case report.  This includes answering questions like: Do I need written HIPAA authorization to publish a case report?  When do I need IRB review of a case report?  What qualifies as a patient identifier?

How do I get started?

1. We STRONGLY encourage you to consult the CARE Guidelines, which provide guidance on writing case reports -  https://www.care-statement.org/

Specifically, the checklist -  https://www.care-statement.org/checklist  - which explains exactly the information you should collect and include in your case report.  

2. Identify a case.  If you are a medical student, you may not yet have the clinical expertise to determine if a specific case is worth writing up.  If so, you must seek the help of a clinician.  It is common for students to ask attendings or residents if they have any interesting cases that can be used for a case report. 

3. Select a journal or two to which you think you will submit the case report.   Journals often have specific requirements for publishing case reports, which could include a requirement for informed consent, a letter or statement from the IRB and other things.  Journals may also charge publication fees (see Is it free to publish? below)   

4. Obtain informed consent from the patient (see " Do I have to obtain informed consent from the patient? " below).  Journals may have their own informed consent form that they would like you to use, so please look for this when selecting a journal.

Once you've identified the case, selected an appropriate journal(s), and considered informed consent, you can collect the required information to write the case report.

How do I write a case report?

Once you identify a case and have learned what information to include in the case report, try to find a previously published case report.  Finding published case reports in a similar field will provide examples to guide you through the process of writing a case report.    

One journal you can consult is BMJ Case Reports .  MSU has an institutional fellowship with BMJ Case Reports which allows MSU faculty, staff and students to publish in this journal for free.  See this page for a link to the journal and more information on publishing-    https://lib.msu.edu/medicalwriting_publishing/

There are numerous other journals where you can find published case reports to help guide you in your writing. 

Do I have to obtain informed consent from the patient?

The CARE guidelines recommend obtaining informed consent from patients for all case reports.  Our recommendation is to obtain informed consent from the patient.  Although not technically required, especially if the case report does not include any identifying information, some journals require informed consent for all case reports before publishing.  The CARE guidelines recommend obtaining informed consent AND the patient's perspective on the treatment/outcome (if possible).  Please consider this as well.  

If required, it is recommended you obtain informed consent before the case report is written.

An example of a case report consent form can be found on the BMJ Case Reports website, which you can access via the MSU library page -  https://casereports.bmj.com/ .  Go to "Instructions for Authors" and then "Patient Consent" to find the consent form they use.  You can create a similar form to obtain consent from your patient.  If you have identified a journal already, please consult their requirements and determine if they have a specific consent form they would like you to use.

Seek feedback

Once you have written a draft of the case report, you should seek feedback on your writing, from experts in the field if possible, or from those who have written case reports before.   

Selecting a journal

Aside from BMJ Case Reports mentioned above, there are many, many journals out there who publish medical case reports.   Ask your mentor if they have a journal they would like to use.  If you need to select on your own, here are some strategies:

1. Do a PubMed search.  https://pubmed.ncbi.nlm.nih.gov/

   a. Do a search for a topic, disease or other feature of your case report 

   b. When the results appear, on the left side of the page is a limiter for "article type".  Case reports are an article type to which you can limit your search results.  If you don't see that option on the left, click "additional filters". 

   c. Review the case reports that come up and see what journals they are published in.

2. Use JANE -  https://jane.biosemantics.org/

3. Check with specialty societies.  Many specialty societies are affiliated with one or more journal, which can be reviewed for ones that match your needs

4. Search through individual publisher journal lists.  Elsevier publishes many different medical research journals, and they have a journal finder, much like JANE  ( https://journalfinder.elsevier.com/ ).  This is exclusive to Elsevier journals.  There are many other publishers of medical journals for review, including Springer, Dove Press, BMJ, BMC, Wiley, Sage, Nature and many others.

Is it free to publish ?

Be aware that it may not be free to publish your case report.  Many journals charge publication fees. Of note, many open access journals charge author fees of thousands of dollars.  Other journals have smaller page charges (i.e. $60 per page), and still others will publish for free, with an "open access option".  It is best practice to check the journal's Info for Authors section or Author Center to determine what the cost is to publish.  MSU-CHM does NOT have funds to support publication costs, so this is an important step if you do not want to pay out of pocket for publishing

*A more thorough discussion on finding a journal, publication costs, predatory journals and other publication-related issues can be found here:   https://research.chm.msu.edu/students-residents/finding-a-journal

Gagnier JJ, Kienle G, Altman DG, Moher D, Sox H, Riley D. 2013. The CARE guidelines: Consensus-based clinical case reporting guideline development.  Glob Adv Health Med . 2:38-43. doi:  10.7453/gahmj.2013.008

Riley DS, Barber MS, Kienle GS, AronsonJK, von Schoen-Angerer T, Tugwell P, Kiene H, Helfand M, Altman DG, Sox H, Werthmann PG, Moher D, Rison RA, Shamseer L, Koch CA, Sun GH, Hanaway P, Sudak NL, Kaszkin-Bettag M, Carpenter JE, Gagnier JJ. 2017.  CARE guidelines for case reports: explanation and elaboration document . J Clin Epidemiol . 89:218-234. doi: 10.1016/j.jclinepi.2017.04.026 

Guidelines to writing a clinical case report. 2017. Heart Views . 18:104-105. doi:  10.4103/1995-705X.217857

Ortega-Loubon C, Culquichicon C, Correa R. The importance of writing and publishing case reports during medical education. 2017. Cureus. 9:e1964. doi:  10.7759/cureus.1964

Writing and publishing a useful and interesting case report. 2019. BMJ Case Reports.  https://casereports.bmj.com/pages/wp-content/uploads/sites/69/2019/04/How-to-write-a-Case-Report-DIGITAL.pdf

Camm CF. Writing an excellent case report: EHJ Case Reports , Case of the Year 2019. 2020. European Heart Jounrnal. 41:1230-1231.  https://doi.org/10.1093/eurheartj/ehaa176  

*content developed by Mark Trottier, PhD

Basics of case report form designing in clinical research

Affiliations.

• 1 Global Medical Affairs, Dr. Reddy's Laboratories Ltd., Hyderabad, India.
• 2 Clinical Research, USV Limited, Mumbai, India.
• PMID: 25276625
• PMCID: PMC4170533
• DOI: 10.4103/2229-3485.140555

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.

Keywords: Case report form; case report form design; completion guidelines; electronic case report form; standard templates.

What are the CARE guidelines?

The CARE guidelines (for CA se RE ports) were developed by an international group of experts to support an increase in the accuracy, transparency, and usefulness of case reports. View and download the CARE checklist here . The CARE guidelines have been endorsed by multiple medical journals and publishers and have been translated into multiple languages. Articles about the CARE guideline development process and a “manual” for writing case reports have been published in 2013 and 2017 in the  Journal of Clinical Epidemiology . The CARE guidelines support the  Equator Network’s  mission to improve health research reporting. Online training to write case reports following the CARE guidelines is available from  Scientific Writing in Health and Medicine (SWIHM) , which also provides access to CARE-writer , an online application for writing case reports as preprints or for submission to a scientific journal.

Why case reports?

Accurate and transparent data collection from episodes of care informs the delivery of high-quality individualized healthcare. “Good case reporting demands a clear focus, to make explicit to the audience why a particular observation is important in the context of existing knowledge” (Vandenbroucke 2001). The CARE guidelines for case reports help authors reduce risk of bias, increase transparency, and provide early signals of what works, for which patients, and under which circumstances. Case reports following the CARE guidelines support the measurement of (1) clinician- and patient-assessed outcomes, (2) effectiveness of Clinical Practice Guidelines (CPGs), and (3) the return on investment (ROI). Healthcare stakeholder groups that benefit from case reports following the CARE guidelines include:

Patients – reviewing and comparing therapeutic options.

Clinicians – engaging in peer-to-peer communication at conferences or in their community.

Researchers – developing testable hypotheses from clinical settings (e.g., Driggers 2016 ).

Educators – systematic case reports from “real-world” clinical practice support case-based learning.

Authors – the CARE guidelines provide tools to inform and simplify the process of writing accurate and transparent case reports.

Medical Journals – the CARE guidelines support “Author Guidelines” and peer review. 

What is CARE-writer?

CARE-writer is an online application that helps authors follow the CARE guidelines as they organize, format and write systematic and transparent case reports and case report preprints. Case reports written with CARE-writer can be posted on preprint servers such as SSRN’s Health Science Case Reports Research Network or submitted to scientific journals.

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To help us share your impact story, send a short description of how and where AHRQ resources were used, along with your contact information, to [email protected] .

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Generation Z – also known as Gen Z, iGen or postmillennial – are a highly collaborative cohort that cares deeply about others and have a pragmatic attitude about how to address a set of inherited issues like climate change, according to research by Roberta Katz, a senior research scholar at Stanford’s Center for Advanced Study in the Behavioral Sciences (CASBS) .

Roberta Katz (Image credit: Charles Katz)

Since 2017, Katz, along with her co-authors, Sarah Ogilvie, a linguist at the University of Oxford and formerly at Stanford; Jane Shaw, a historian who is the principal of Harris Manchester College at Oxford and was previously dean for Religious Life at Stanford; and Linda Woodhead, a sociologist at King’s College London, collaborated as part of a multi-year CASBS research project to better understand a generation who, born between the mid-1990s to around 2010, grew up with digital tools always at their fingertips.

Their findings are based on some 120 interviews gathered on three college campuses – Stanford University; Foothill College, a community college in Los Altos Hills, California; and Lancaster University, a research university in Lancaster, England. A set of focus groups and two surveys in the U.S. and the U.K. were administered to a representative sample of over 2,000 adults aged between 18 and 25 years old.

Contributing further to the scholar’s understanding of Gen Z was the creation of the “ iGen corpus ,” a 70 million item digital repository of spoken and written language of people aged 16 to 25 years that included transcripts from the researchers’ interviews and focus groups, as well as public data from the social media platforms Twitter, Reddit, Twitch, 4chan and YouTube, as well as memes and copypastas from Facebook and Instagram. Ogilvie, the principal investigator on the corpus research team, along with a team of Stanford student research assistants, applied machine learning algorithms to discover the many ways in which young people today express themselves.

Taken together, the scholars’ research offers a snapshot of who Gen Zers really are, what matters to them and why. Findings from Katz’s and her co-authors’ research are detailed in a new book, Gen Z, Explained: The Art of Living in a Digital Age (University of Chicago Press, 2021).

Here, Katz discusses some of what she and her colleagues learned from their extensive research into how Gen Zers, the most diverse generation yet , experience and understand the world.

Based on your research, can you briefly describe the typical Gen Zer?

In summary, a typical Gen Zer is a self-driver who deeply cares about others, strives for a diverse community, is highly collaborative and social, values flexibility, relevance, authenticity and non-hierarchical leadership, and, while dismayed about inherited issues like climate change, has a pragmatic attitude about the work that has to be done to address those issues.

How has growing up in an internet-connected society shaped how Gen Zers see and experience the world and everyday life?

Internet-related technologies have dramatically changed the speed, scale and scope of human communications, resulting in significant changes in how people work, play, shop, find friends and learn about other people. For Gen Zers living in the United States and Britain (the two places we studied), the “norm” they experienced as children was a world that operated at speed, scale and scope. They developed an early facility with powerful digital tools that allowed them to be self-reliant as well as collaborative. Similarly, because they could learn about people and cultures around the globe from an early age, they developed a greater appreciation for diversity and the importance of finding their own unique identities.

What do people most misunderstand or get wrong about Gen Zers?

For quite a while, people were critical of what they saw as a generation that was too coddled and “soft.” Gen Zers were called “snowflakes” and “unwilling to grow up.” But much of that negative judgment came from a misunderstanding of what it is like to grow up in today’s world when compared with how their elders grew up. As an example, Gen Zers have been criticized as lazy because they don’t have after-school or summer jobs. But many Gen Zers have been earning significant dollars online through a variety of activities, even including product placements on fashion-advice sites. Another example concerns drivers’ licenses: older people, for whom getting a driver’s license was a rite of passage toward adulthood, have criticized Gen Zers who do not rush to take their driver’s tests when they turn 16, but this criticism fails to consider that Gen Zers have no need to drive when they have ready access to ride services like Uber and Lyft.

Do you think Gen Zers get an undeserved bad rap?

Yes, but that is changing. Of late, many people are beginning to appreciate the strength and pragmatism of Gen Zers.

What were you most surprised to learn about Gen Zers?

Our biggest surprise came in response to this interview question: “What type of communication do you like best?” We expected the interviewees to respond with their favorite type of digital communication – e.g., text, email, chat group, DM, FaceTime, Skype, etc. – but instead nearly every single person said their favorite form of communication was “in person.”

As Gen Zers enter the workforce, what would be helpful for other generations to know about their post-millennial colleagues?

For those who are now experiencing Gen Zers in the workplace, my advice is to recognize that these new colleagues are used to working collaboratively and flexibly, with an eye to being efficient in getting the job done. They are pragmatic and value direct communication, authenticity and relevance. They also value self-care. They may be more likely than older people were when they were the age of the Gen Zers to question rules and authority because they are so used to finding what they need on their own. They are not always right; often they don’t know what they need, especially in a new setting, and this is where inter-generational dialogue can be so helpful. Both the older and the younger colleagues can learn from the other, in each case by listening with more respect, appreciation and trust. The older colleague can learn some helpful new ways of getting a job done, while the younger colleague may learn good reasons for why things have long been done in a certain way. Without that dialogue, we’ll have a wasteful tug of war between the past and the future. The goal is for older and younger generations to work together, with openness and trust, to ensure that the wisdom – but not what has become the excess baggage – of the past is not lost to the future.

How has studying Gen Zers changed your own interactions with this generation?

I came to understand that Gen Zers are, on the whole, much better adapted to life in a digital age than those of us who are older and that they can be very frustrated by what appear to them to be outdated and often irrelevant ways of doing things. As one simple example that we cite in the book, an older person would likely assume that any organization needs a set of officers, for that has been the norm in their experience, but a Gen Zer would say, from their lived experience, that there is no need to elect officers (or other leaders) if the group can accomplish its mission through online collaborations that take advantage of the participants’ diverse skills.

In my own interactions with Gen Zers, I am much more likely than I used to be to listen closely to what they say, and to refrain from making a judgment about their ideas, values and behaviors based on an assumption that they are wrong and I am right. They often do things differently, have some different values and have some different ideas about the future than I do, and I have come to appreciate and trust that they often have a new and better approach. Many of us who are older have a different understanding of how the world works, which is rooted in our own early experiences, so it’s easy for us to assume that the world will continue to operate in much the same way going forward and that the young people need to adapt to that older way of living. But the younger people are necessarily future-oriented, and as we all are increasingly coming to appreciate, the digital-age future is quite different from the industrial-age past.

For 13 years, Katz served under Stanford University Presidents John Hennessy and Marc Tessier-Lavigne as the associate vice president for strategic planning. She also served as President Tessier-Lavigne’s interim chief of staff until early 2017. Katz has been deeply involved in the facilitation of a variety of interdisciplinary research initiatives at Stanford, and she is a current member of the CASBS board of directors.

This research was funded by the Knight Foundation.

Stanford University

The Walter H. Shorenstein Asia-Pacific Research Center is part of the Freeman Spogli Institute for International Studies

New Report Sheds Light on People's Liberation Army’s Role in Escalating Indo-Pacific Tensions

In recent years, China's military modernization and assertive actions have led to more frequent and dangerous encounters between the People's Liberation Army (PLA) and the militaries of key regional players in the Indo-Pacific. Each encounter heightens the chance of a military conflict in the region. A new report published by the National Bureau of Asian Research (NBR) assesses the PLA’s strategic thinking on escalation control, analyzing the potential for conflict in the region and exploring regional responses and implications for deterrence.

Edited by Chinese military expert Oriana Skylar Mastro , a center fellow at APARC and the Freeman Spogli Institute for International Studies, the report, " Encounters and Escalation in the Indo-Pacific: Perspectives on China’s Military and Implications for Regional Security ," comprises six essays, each detailing an encounter with the PLA. These case studies include China’s maritime disputes with Japan, the Philippines, and Vietnam and its increasingly aggressive military activities vis-à-vis Australia, India, and Taiwan.

The authors of the essays are current and former practitioners with insight into their government’s experiences and thinking. Their assessments emphasize the need for Asia-Pacific countries to reevaluate their defense capabilities and adopt clear and consistent policy approaches to navigate the complex geopolitical landscape in the region.

Sign up for APARC newsletters to receive updates on our experts’ research and publications >

Tactics, Intentions, and Shared Threat Perceptions

As the PLA adopts a more assertive approach beyond its maritime boundaries, nations across the Indo-Pacific region have increasingly experienced perilous encounters with the Chinese military. For example, the PLA's intensifying aggression around Second Thomas Shoal in the South China Sea led to several incidents of maritime tension with the Philippines . Likewise, a Chinese fighter aircraft intercepted an Australian surveillance aircraft during its routine activity in international airspace over the South China Sea, posing a safety risk to the Australian aircraft and its crew.

The authors of the six case studies in the NBR report agree "that China harbors problematic intentions and is using increasingly aggressive and risk-acceptant tactics to accomplish its goals." While they show that China uses different tactics in different situations and differ in their evaluations of the most troublesome tactics for their respective countries, their analyses share several common themes, which Mastro reviews in her introduction to the report, titled " Close Encounters with the PLA: Regional Experiences and Implications for Deterrence ."

First, “China doctrinally does not take any responsibility for the deterioration in the strategic environment,” writes Mastro. “All six case studies mention China’s tendency to publicly blame the other country for whatever crisis unfolded.”

China also sees crises as opportunities, Mastro explains, and most case studies indicate that the crises at stake were deliberate acts of PLA escalation. All case studies also reflect Chinese strategic thinking on deterrence as serving dual purposes: firstly, to discourage adversaries from certain actions, and secondly, to influence their behavior in line with the deterrer's intentions, ultimately requiring them to comply with the deterrer's preferences.

Another common theme is that the PLA's assertive actions have prompted all six nations studied in the report to boost security cooperation with the United States and other regional powers, albeit to varying extents. For example, in addition to enhancing its strategic partnership with the United States, India has enhanced its defense ties with the two other Quad members (Japan and Australia) and regional partners such as Vietnam, Singapore, and the Philippines.

Moreover, based on their encounters with the PLA, almost all regional players have concluded that strengthening their military capabilities will discourage Chinese aggressive behavior in the future, Mastro says, noting that “changes in defense posture have perhaps been the most drastic in Japan.”

Policy Implications

The report's case studies offer policy recommendations for deterring China, emphasizing the importance of a consistent approach that includes strengthening deterrence capabilities through military modernization, firm stances on border disputes, and close security cooperation with the United States, its allies, and other like-minded nations. While there is consensus that military deterrence needs to be balanced with diplomatic engagements to reduce tensions, each regional player views the effectiveness of diplomacy and cooperation with China differently.

“Ultimately,” Mastro concludes, “the path forward for maintaining peace and stability in the Indo-Pacific region requires a cohesive strategy that prioritizes long-term security interests, demonstrating the essential role of international cooperation and the strategic interplay between military readiness and diplomatic efforts in navigating China’s aggression.”

Learn more about the report and download Mastro’s introductory essay > 

Related Research

Deciphering the nature of the sino-russian military alignment, the next tripartite pact, aparc launches new taiwan program, igniting dialogue on taiwan’s future.

Adding life to years: Healthy Ageing Challenge impact report

Final report for the UKRI Healthy Ageing Challenge, delivered by Innovate UK and ESRC, demonstrating the impact on academia, social enterprise and industry.

Adding life to years: achieving impact for healthier later lives (PDF)

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This report provides a comprehensive overview of the Healthy Ageing Challenge impacts, featuring key statistics, case studies, and testimonials.

It demonstrates how the UKRI Healthy Ageing Challenge has energised a community of innovators and researchers from a wide range of industries and academic disciplines, working towards the vision of the challenge: to enable people to remain active, productive, independent and socially connected across the generations for as long as possible.

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Study Design 101: Case Report

• Case Report
• Case Control Study
• Cohort Study
• Randomized Controlled Trial
• Practice Guideline
• Systematic Review
• Meta-Analysis
• Helpful Formulas
• Finding Specific Study Types
• Case Reports

An article that describes and interprets an individual case, often written in the form of a detailed story. Case reports often describe:

• Unique cases that cannot be explained by known diseases or syndromes
• Cases that show an important variation of a disease or condition
• Cases that show unexpected events that may yield new or useful information
• Cases in which one patient has two or more unexpected diseases or disorders

Case reports are considered the lowest level of evidence, but they are also the first line of evidence, because they are where new issues and ideas emerge. This is why they form the base of our pyramid. A good case report will be clear about the importance of the observation being reported.

If multiple case reports show something similar, the next step might be a case-control study to determine if there is a relationship between the relevant variables.

• Can help in the identification of new trends or diseases
• Can help detect new drug side effects and potential uses (adverse or beneficial)
• Educational - a way of sharing lessons learned
• Identifies rare manifestations of a disease

Disadvantages

• Cases may not be generalizable
• Not based on systematic studies
• Causes or associations may have other explanations
• Can be seen as emphasizing the bizarre or focusing on misleading elements

Design pitfalls to look out for

The patient should be described in detail, allowing others to identify patients with similar characteristics.

Does the case report provide information about the patient's age, sex, ethnicity, race, employment status, social situation, medical history, diagnosis, prognosis, previous treatments, past and current diagnostic test results, medications, psychological tests, clinical and functional assessments, and current intervention?

Case reports should include carefully recorded, unbiased observations.

Does the case report include measurements and/or recorded observations of the case? Does it show a bias?

Case reports should explore and infer, not confirm, deduce, or prove. They cannot demonstrate causality or argue for the adoption of a new treatment approach.

Does the case report present a hypothesis that can be confirmed by another type of study?

Fictitious Example

A physician treated a young and otherwise healthy patient who came to her office reporting numbness all over her body. The physician could not determine any reason for this numbness and had never seen anything like it. After taking an extensive history the physician discovered that the patient had recently been to the beach for a vacation and had used a very new type of spray sunscreen. The patient had stored the sunscreen in her cooler at the beach because she liked the feel of the cool spray in the hot sun. The physician suspected that the spray sunscreen had undergone a chemical reaction from the coldness which caused the numbness. She also suspected that because this is a new type of sunscreen other physicians may soon be seeing patients with this numbness.

The physician wrote up a case report describing how the numbness presented, how and why she concluded it was the spray sunscreen, and how she treated the patient. Later, when other doctors began seeing patients with this numbness, they found this case report helpful as a starting point in treating their patients.

Real-life Examples

Hymes KB. Cheung T. Greene JB. Prose NS. Marcus A. Ballard H. William DC. Laubenstein LJ. (1981). Kaposi's sarcoma in homosexual men-a report of eight cases. Lancet. 2 (8247),598-600.

This case report was published by eight physicians in New York city who had unexpectedly seen eight male patients with Kaposi's sarcoma (KS). Prior to this, KS was very rare in the U.S. and occurred primarily in the lower extremities of older patients. These cases were decades younger, had generalized KS, and a much lower rate of survival. This was before the discovery of HIV or the use of the term AIDS and this case report was one of the first published items about AIDS patients.

Wu, E. B., & Sung, J. J. Y. (2003). Haemorrhagic-fever-like changes and normal chest radiograph in a doctor with SARS. Lancet, 361 (9368), 1520-1521.

This case report is written by the patient, a physician who contracted SARS, and his colleague who treated him, during the 2003 outbreak of SARS in Hong Kong. They describe how the disease progressed in Dr. Wu and based on Dr. Wu's case, advised that a chest CT showed hidden pneumonic changes and facilitate a rapid diagnosis.

Related Terms

Case Series

A report about a small group of similar cases.

Preplanned Case-Observation

A case in which symptoms are elicited to study disease mechanisms. (Ex. Having a patient sleep in a lab to do brain imaging for a sleep disorder).

Now test yourself!

1. Case studies are not considered evidence-based even though the authors have studied the case in great depth.

2. When are Case reports most useful?

When you encounter common cases and need more information When new symptoms or outcomes are unidentified When developing practice guidelines When the population being studied is very large

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Research: Negotiating Is Unlikely to Jeopardize Your Job Offer

• Einav Hart,
• Julia Bear,
• Zhiying (Bella) Ren

A series of seven studies found that candidates have more power than they assume.

Job seekers worry about negotiating an offer for many reasons, including the worst-case scenario that the offer will be rescinded. Across a series of seven studies, researchers found that these fears are consistently exaggerated: Candidates think they are much more likely to jeopardize a deal than managers report they are. This fear can lead candidates to avoid negotiating altogether. The authors explore two reasons driving this fear and offer research-backed advice on how anxious candidates can approach job negotiations.

Imagine that you just received a job offer for a position you are excited about. Now what? You might consider negotiating for a higher salary, job flexibility, or other benefits , but you’re apprehensive. You can’t help thinking: What if I don’t get what I ask for? Or, in the worst-case scenario, what if the hiring manager decides to withdraw the offer?

• Einav Hart is an assistant professor of management at George Mason University’s Costello College of Business, and a visiting scholar at the Wharton School. Her research interests include conflict management, negotiations, and organizational behavior.
• Julia Bear is a professor of organizational behavior at the College of Business at Stony Brook University (SUNY). Her research interests include the influence of gender on negotiation, as well as understanding gender gaps in organizations more broadly.
• Zhiying (Bella) Ren is a doctoral student at the Wharton School of the University of Pennsylvania. Her research focuses on conversational dynamics in organizations and negotiations.

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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.