CHM Office of Reseach

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

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How to Write a Medical Case Study Report

Last Updated: July 5, 2022 Fact Checked

This article was medically reviewed by Mark Ziats, MD, PhD and by wikiHow staff writer, Jennifer Mueller, JD . Dr. Mark Ziats is an Internal Medicine Physician, Scientist, Entrepreneur, and the Medical Director of xBiotech. With over five years of experience, he specializes in biotechnology, genomics, and medical devices. He earned a Doctor of Medicine degree from Baylor College of Medicine, a Ph.D. in Genetics from the University of Cambridge, and a BS in Biochemistry and Chemistry from Clemson University. He also completed the INNoVATE Program in Biotechnology Entrepreneurship at The Johns Hopkins University - Carey Business School. Dr. Ziats is board certified by the American Board of Internal Medicine. There are 16 references cited in this article, which can be found at the bottom of the page. This article has been fact-checked, ensuring the accuracy of any cited facts and confirming the authority of its sources. This article has been viewed 185,346 times.

You've encountered an interesting and unusual case on your rounds, and a colleague or supervising physician says, "Why don't you write up a case study report?" If you've never written one before, that might sound intimidating, but it's a great way to get started in medical writing. Case studies always follow a standard structure and format, so the writing is very formulaic once you get the hang of it. Read on for a step-by-step guide to writing your first case study report.

What is a case study report?

Step 1 A case study report is an academic publication describing an unusual or unique case.

  • Medical students or residents typically do the bulk of the writing of the report. If you're just starting your medical career, a case study report is a great way to get a publication under your belt. [2] X Research source

Step 2 Your report discusses the case presented by one patient.

  • If the patient is a minor or is incapable of giving informed consent, get consent from their parents or closest relative. [4] X Trustworthy Source PubMed Central Journal archive from the U.S. National Institutes of Health Go to source
  • Your hospital likely has specific consent forms to use. Ask your supervising physician if you're not sure where to get one.
  • Some journals also have their own consent form. Check your target journal's author or submission information to make sure. [5] X Research source

How is a case study report structured?

Step 1 A typical report consists of an abstract, intro, case description, discussion, and conclusion.

  • Even though the introduction is the first part of a case study report, doctors typically write it last. You'll have a better idea of how to introduce your case study to readers after you've written it.
  • Your abstract comes at the top, before the introduction, and provides a brief summary of the entire report. Unless your case study is published in an open-access journal, the abstract is the only part of the article many readers will see.

Step 2 Check your target journal for possible variations.

  • Many journals offer templates and checklists you can use to make sure your case study includes everything necessary and is formatted properly—take advantage of these! Some journals, such as BMJ Case Reports , require all case studies submitted to use their templates.

Drafting Your Medical Case Study Report

Step 1 Pull all of the hospital records for the case.

  • Patient description
  • Chronological case history
  • Physical exam results
  • Results of any pathological tests, imaging, or other investigations
  • Treatment plan
  • Expected outcome of treatment
  • Actual outcome of treatment

Step 2 Write a draft of the case presentation.

  • Why the patient sought medical help (you can even use their own words)
  • Important information that helped you settle on your diagnosis
  • The results of your clinical examination, including diagnostic tests and their results, along with any helpful images
  • A description of the treatment plan
  • The outcome, including how and why treatment ended and how long the patient was under your care [11] X Trustworthy Source PubMed Central Journal archive from the U.S. National Institutes of Health Go to source

Step 3 Research the existing literature on the patient's condition and treatment.

  • You will need references to back up symptoms of the condition, common treatment, and the expected outcome of that common treatment.
  • Use your research to paint a picture of the usual case of a patient with a similar condition—it'll help you show how unusual and different your patient's case is.
  • Generally, aim for around 20 references—no fewer than 15, but no more than 25. [13] X Trustworthy Source PubMed Central Journal archive from the U.S. National Institutes of Health Go to source

Step 4 Write a section discussing the case in light of your research.

  • Close your discussion section with a summary of the lessons learned from the case and why it's significant to consider when treating similar cases in the future.
  • Outline any open questions that remain. You might also provide suggestions for future research.

Step 5 Complete your introduction and conclusion after you've written the body.

  • In your conclusion, you might also give suggestions or recommendations to readers based on what you learned as a result of the case.
  • Some journals don't want a separate conclusion section. If that's the case for one of your target journals, just move this paragraph to the end of your discussion section.

Polishing Your Report for Submission to Publishers

Step 1 Come up with a title for your case study.

  • Most titles are fewer than 10 words long and include the name of the disease or condition treated.
  • You might also include the treatment used and whether the outcome was successful. When deciding what to include, think about the reason you wrote the case study in the first place and why you think it's important for other clinicians to read.

Step 2 Identify the authors of the report on the title page.

  • Made a significant intellectual contribution to the case study report
  • Was involved in the medical care of the patient reported
  • Can explain and defend the data presented in the report
  • Has approved the final manuscript before submission for publication

Step 3 Write an abstract summarizing the entire article.

  • Keep in mind that the abstract is not just going to be the first thing people read—it will often be the only thing people read. Make sure that if someone is going to walk away having only read the abstract, they'll still get the same message they would have if they read the whole thing.
  • There are 2 basic types of abstract: narrative and structured. A narrative abstract is a single paragraph written in narrative prose. A structured abstract includes headings that correspond with the sections of the paper, then a brief summary of each section. Use the format preferred by your target journal.

Step 4 Choose keywords that will help readers find your case study.

  • Look for keywords that are relevant to your field or sub-field and directly related to the content of your article, such as the name of the condition or specific treatments you used.
  • Most journals allow 4-8 keywords but check the submission guidelines of your target journal to make sure.

Step 5 Obscure the patient's identity.

  • Blur out the patient's face as well as any tattoos, birthmarks, or unrelated scars that are visible in diagnostic images.

Step 6 Include your acknowledgments and conflict of interest statement.

  • It's common to thank the patient, but that's up to you. Even if you don't, include a statement indicating that you have the patient's written, informed consent to publish the information.
  • Read the journal's submission guidelines for a definition of what that journal considers a conflict of interest. They're generally the same, but some might be stricter than others. [22] X Research source

Step 7 Compile and format your reference section.

  • If you're not familiar with the citation style used by your target journal, check online for a guide. There might also be one available at your hospital or medical school library.
  • Medical librarians can also help with citation style and references if you run into something tricky—don't just wing it! Correct citation style insures that readers can access the materials you cite.

Step 8 Get feedback on your final draft.

  • It's also a good idea to get a beta reader who isn't a medical professional. Their comments can help you figure out where you need to clarify your points.
  • Read a lot of case studies published in your target journals—it will help you internalize the tone and style that journal is looking for.

Submitting Your Report to Publishers

Step 1 Choose target journals that publish similar content.

  • Look into the background and reputation of journals before you decide to submit to them. Only seek publication from reputable journals in which articles go through a peer-review process.
  • Find out what publishing fees the journals charge. Keep in mind that open-access journals tend to charge higher publishing fees. [26] X Research source
  • Read each journal's submission and editorial guidelines carefully. They'll tell you exactly how to format your case study, how long each section should be, and what citation style to use. [27] X Research source
  • For electronic journals that only publish case reports, try BMJ Case Reports , Journal of Medical Case Reports , or Radiology Case Reports .

Step 2 Submit your manuscript according to the journal's requirements.

  • If your manuscript isn't suitable for the journal you submitted to, the journal might offer to forward it to an associated journal where it would be a better fit.
  • When your manuscript is provisionally accepted, the journal will send it to other doctors for evaluation under the peer-review process.
  • Most medical journals don't accept simultaneous submissions, meaning you'll have to submit to your first choice, wait for their decision, then move to the next journal on the list if they don't bite.

Step 3 Revise your manuscript based on peer review comments.

  • Along with your revised manuscript, include a letter with your response to each of the reviewer's comments. Where you made revisions, add page numbers to indicate where the revisions are that address that reviewer's comments.
  • Sometimes, doctors involved in the peer review process will indicate that the journal should reject the manuscript. If that's the case, you'll get a letter explaining why your case study report won't be published and you're free to submit it elsewhere.

Step 4 Complete final copy-editing if the editors approve your article.

  • Some journals require you to have your article professionally copy-edited at your own cost while others do this in-house. The editors will let you know what you're responsible for.

Step 5 Pay the article processing charge if your article is accepted.

  • With your acceptance letter, you'll get instructions on how to make payment and how much you owe. Take note of the deadline and make sure you pay it as soon as possible to avoid publication delays.
  • Some journals will publish for free, with an "open-access option" that allows you to pay a fee only if you want open access to your article. [32] X Research source

Step 6 Sign your publishing agreement.

  • Through the publishing agreement, you assign your copyright in the article to the journal. This allows the journal to legally publish your work. That assignment can be exclusive or non-exclusive and may only last for a specific term. Read these details carefully!
  • If you published an open-access article, you don't assign the copyright to the publisher. The publishing agreement merely gives the journal the right to publish the "Version of Record." [34] X Research source

How do I find a suitable case for a report?

Step 1 Keep your eye out for unusual or interesting cases.

  • A rare disease, or unusual presentation of any disease
  • An unusual combination of diseases or conditions
  • A difficult or inconclusive diagnosis
  • Unexpected developments or responses to treatment
  • Personal impact
  • Observations that shed new light on the patient's disease or condition

Step 2 Discuss possible cases with your medical team.

  • There might be other members of your medical team that want to help with writing. If so, use one of these brainstorming sessions to divvy up writing responsibilities in a way that makes the most sense given your relative skills and experience.
  • Senior doctors might also be able to name some journals that would potentially publish your case study. [37] X Research source

Expert Q&A

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  • ↑ https://www.elsevier.com/connect/authors-update/the-dos-and-donts-of-writing-and-publishing-case-reports
  • ↑ https://www.bmj.com/content/350/bmj.h2693
  • ↑ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5686928/
  • ↑ https://health.usf.edu/medicine/internalmedicine/im-impact/~/media/B3A3421F4C144FA090AE965C21791A3C.ashx
  • ↑ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2597880/
  • ↑ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6476221/
  • ↑ https://www.springer.com/gp/authors-editors/authorandreviewertutorials/writing-a-journal-manuscript/title-abstract-and-keywords/10285522
  • ↑ http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2597880/
  • ↑ https://thelancet.com/pb/assets/raw/Lancet/authors/tl-info-for-authors.pdf
  • ↑ https://jmedicalcasereports.biomedcentral.com/articles/10.1186/s13256-017-1351-y
  • ↑ https://guides.himmelfarb.gwu.edu/casereports
  • ↑ https://casereports.bmj.com/pages/authors/
  • ↑ https://jmedicalcasereports.biomedcentral.com/articles/10.1186/1752-1947-7-239
  • ↑ https://research.chm.msu.edu/students-residents/writing-a-case-report
  • ↑ https://www.elsevier.com/__data/assets/pdf_file/0006/98619/Sample-P-copyright-2.pdf
  • ↑ https://authorservices.taylorandfrancis.com/publishing-your-research/moving-through-production/copyright-for-journal-authors/#

About This Article

Mark Ziats, MD, PhD

Medical Disclaimer

The content of this article is not intended to be a substitute for professional medical advice, examination, diagnosis, or treatment. You should always contact your doctor or other qualified healthcare professional before starting, changing, or stopping any kind of health treatment.

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To start a medical case study report, first choose a title that clearly reflects the contents of the report. You’ll also need to list any participating authors and develop a list of keywords, as well as an abstract summarizing the report. Your report will need to include an introduction summarizing the context of the report, as well as a detailed presentation of the case. Don’t forget to include a thorough citation list and acknowledgements of anyone else who participated in the study. For more tips from our Medical co-author, including how to get your case study report published, keep reading! Did this summary help you? Yes No

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Article Contents

Format of the patient case report, appendix a—criteria for publishable case reports, appendix b—guidelines for writing patient case report manuscripts.

  • < Previous

How to write a patient case report

  • Article contents
  • Figures & tables
  • Supplementary Data

Henry Cohen, How to write a patient case report, American Journal of Health-System Pharmacy , Volume 63, Issue 19, 1 October 2006, Pages 1888–1892, https://doi.org/10.2146/ajhp060182

  • Permissions Icon Permissions

Purpose. Guidelines for writing patient case reports, with a focus on medication-related reports, are provided.

Summary. The format of a patient case report encompasses the following five sections: an abstract, an introduction and objective that contain a literature review, a description of the case report, a discussion that includes a detailed explanation of the literature review, a summary of the case, and a conclusion. The abstract of a patient case report should succinctly include the four sections of the main text of the report. The introduction section should provide the subject, purpose, and merit of the case report. It must explain why the case report is novel or merits review, and it should include a comprehensive literature review that corroborates the author’s claims. The case presentation section should describe the case in chronological order and in enough detail for the reader to establish his or her own conclusions about the case’s validity. The discussion section is the most important section of the case report. It ought to evaluate the patient case for accuracy, validity, and uniqueness; compare and contrast the case report with the published literature; derive new knowledge; summarize the essential features of the report; and draw recommendations. The conclusion section should be brief and provide a conclusion with evidence-based recommendations and applicability to practice.

Conclusion. Patient case reports are valuable resources of new and unusual information that may lead to vital research.

Published patient case reports provide essential sources of information for the optimum care of patients because case reports can describe important scientific observations that are missed or are undetectable in clinical trials, provide insightful information that expands our knowledge and spawns new research, and provide information that strays from the classical textbook case and leads to better and safer patient care. Indeed, a case report of Kaposi’s sarcoma in a young homosexual man is the seminal observation to the development of acquired immune deficiency syndrome. 1 Seminal patient case reports linked the Food and Drug Administration-approved indication for the anorexic agents, fenfluramine and dexfenfluramine, with primary pulmonary hypertension and subsequently spawned trials that evaluated the mechanism, incidence, and risk factors of this adverse effect, culminating in their withdrawal from the market. 2 , – 5

Many biomedical journals publish case reports and provide authors with guidelines that provide instruction for acceptance criteria, content, and format. The types of relevant patient case reports that merit publication are listed in Appendix A. This article will provide guidelines for writing patient case reports, with a focus on medication-related reports.

Case reports should encompass the following five sections: an abstract, an introduction and objective with a literature review, a description of the case report, a discussion that includes a detailed explanation of the literature review, a summary of the case, and a conclusion. 6 , 7 Supplementary parts such as tables, figures, graphs, and illustrations provide essential data and will enhance the article’s flow and clarity. Generally, most of the data contained in supplementary parts should not be duplicated in the text. 6 , 7 Patient case reports can describe a single case report or a series of case reports. Case reports are generally 1500–2500 words in length with 20–30 references. The title of the case report should be descriptive, accurate, and succinct.

Case reports should include an abstract of 100–250 words. The availability of an abstract will allow for easier retrieval from electronic databases and help researchers discern their levels of interest in the case report. The abstract should include the same four sections as the main text in a succinct form—introduction and objective, case presentation, discussion, and conclusion—but the format may vary depending on a journal’s style if submitted for publication.

Introduction

The introduction section should be concise and salient and immediately attract the attention and interest of the reader. The introduction should provide the subject, purpose, and merit of the case report. It should present background information that provides clarity to the subject of discussion. This should be followed by an explanation of why the case report is novel or merits review. A focused comprehensive literature review that corroborates the author’s claims should accompany the introduction. If few citations are found, they should all be cited chronologically; however, if many citations are found, the seminal, historical, and most pertinent references should be cited. The significant details from the literature review and how those details compare and contrast to the current case should be explained in the discussion, not in the introduction. A brief one-or two-sentence description of the patient case should be provided and is an excellent segue for the case presentation section. The introduction should not be more than three paragraphs and does not need to be labeled with a heading (i.e., Introduction).

A literature review should list the strategy and extent of the search and should include the database searched, the dates that the database was searched, the languages covered, and the search terms used. The literature search should provide enough detail for the reader to easily reproduce the search. Databases that are commonly searched because of their comprehensiveness of biomedical content include MEDLINE and EMBASE. However, it is important that the breadth of the search uses databases that contain information that may not be found in MEDLINE or EMBASE. For example, a case report of an adverse drug event or medication error should include a review of an adverse reaction database such as Clin-Alert or databases that review pharmacy publications such as International Pharmaceutical Abstracts and Iowa Drug Information Service. A case report describing the collaboration of a pharmacist and a nurse that improves a patient’s care should include a search in the nursing database such as the Cumulative Index to Nursing and Allied Health Literature. Furthermore, to maximize the literature search findings, authors should meticulously search the reference lists of review articles and meta-analyses. Finally, clinicians ought to be cognizant that early reports may not be detected in a literature search because of changes in concepts, nomenclature, and terminology since their publication date.

Case presentation

The description of the patient case is one of the most integral sections of the case report. It should describe the case in chronological order and in enough detail for the reader to establish his or her own conclusions about the case’s validity. A case report that contains detailed and relevant patient information allows the reader with a different clinical expertise to uncover idiosyncracies that are not detected or described by the author and stimulates further inquiry and commentary. The case presentation should only include information that pertains to the case and refrain from providing confusing and superfluous data. Daily patient progress including normal vital signs, routine laboratory results, typical consultation with other disciplines, step-down transfers to wards, and other irrelevant patient information must be avoided. The author should establish a causal and temporal relationship and indicate the effect of treatment, any unanticipated effects, the patient’s final outcome, any further proposed treatments, and the patient’s present status at the time of the report.

Patient’s demographics and history

Patient demographics such as age, height, weight, sex, race, and occupation must be included. Although the race or occupation of the patient may appear as superfluous, this type of information may uncover pharmacogenomic or environmental influences. In order to limit the possibility of identifying the patient, the patient’s initials, date of birth, and other identifiers must not be used. Precise dates, including the month, day, and year of admission or other important events, should be avoided—they can aid in identifying the patient and detract the reader from the case report by calculating elapsed time. In a brief summary and in a narrative form, the patient’s chief complaint, present illness, medical history, family and social history, and use of recreational drugs should be listed. Headings for each part of the patient’s history should not be used. The type of physical examination performed should be described, and any abnormalities should be reported.

Patient’s laboratory and diagnostic data

The patient’s laboratory values and diagnostic data that support the case report and rule out a differential diagnosis should be reported. Pertinent positive or negative laboratory results must be provided. When the reference range of a laboratory value is not widely known or established, it should be provided in parentheses. Diagnostic procedures, the timeline in which they were administered, and a brief report of the results should be included. A verbatim description of a pathologist’s report must not be used; instead, a salient report of the results should be included. Pictures of histopathology, roentgenograms, electrocardiographs, and other diagnostic tests; skin manifestations; wounds; and other anatomical parts may be provided and add to the interest of the report. Any identifying features of a patient’s photograph should be blocked out. Institutional policies and patient permission for obtaining and using photographs must be followed.

Patient’s medication history

The patient’s medication history should include the medication’s name, strength, dosage form, route, and dates of administration. The brand or generic name of the drug and the name of the manufacturer may be relevant to the case and should be listed. Brand and generic drugs may have different bioavailability factors or may contain different fillers, preservatives, additives, or dyes—all of which may be pertinent to cases regarding the drugs’ pharmacokinetics, efficacy, and adverse effects. Since a medication history may often omit herbals, vaccines, depot injections, and nonprescription medications, the author should specify the history of each of these medication types. The dates a medication was discontinued should be identified, since medications may have lasting effects for months after discontinuation. The author should verify and inform the reader of the patient’s history of medication adherence.

In order to evaluate the appropriateness of a medication’s dosage regimen, laboratory values that describe renal and hepatic organ functions should be provided. Renal function values should include serum creatinine, blood urea nitrogen, and the total fluid volume intake and excretion when a urinary catheter is in place. Calculation methods used to estimate the patient’s renal function should be identified. Liver function tests such as the International Normalized Ratio, serum albumin, and albumin:globulin ratio and hepatic enzyme tests such as aspartate and alanine aminotransferases should be provided.

A comprehensive medication history should also include the patient’s allergy status. The allergy history should include the date of the reaction, the name of the drug, and the type of allergic manifestation. The name of the drug should be listed as either the generic or brand name, and combination products should be listed as such. Allergies to combination products such as Unasyn and Zosyn can be mislabeled as a penicillin allergy rather than a sulfone allergy or vice versa. Similarly, an allergy to Septra or Bactrim can be mislabeled as an allergy to sulfonamide rather than to trimethoprim or vice versa. Some nonallergic adverse drug reactions such as drug-induced seizures may not be included in the allergy history; nevertheless, the author should investigate and report such data.

When available, drug serum levels ought to be listed along with the time they were drawn and their relationship to the dosage of the medication administered (e.g., trough, peak). Drug serum levels should delineate between total and free levels (e.g., phenytoin, valproic acid). Since there may be intralaboratory variations in drug serum reference ranges, the reference range should always be provided in parentheses. When pertinent to the case, the method of drug serum level assay should also be included.

Patient’s diet

The patient’s diet history ought to be included in the case report. Food can interact with medications, yielding lower or higher serum drug levels or increasing or decreasing the drug’s pharmacologic effect. The patient’s diet can have consequential effects on a disease state. Dietary causes of adverse events, such as allergic reactions, should be ruled out before suspecting a drug allergy.

The discussion section is the most important section of the case report. The discussion should evaluate the patient case for accuracy, validity, and uniqueness; compare and contrast the case report with the published literature; and derive new knowledge and applicability to practice. The author must confirm that the case report is valid by ensuring the accuracy of the data presented and by establishing a temporal and causal relationship. For drug-induced adverse effects, a validated nomogram to establish the probability of causality such as the Naranjo nomogram must be used. 8

The author should comprehensively list the limitations of the case and should describe the significance of each limitation. The author should briefly summarize the published literature derived from the literature review and may provide a detailed summary of a few citations. A table listing the pertinent facts of the cases detected from the literature review is a simple method for providing extensive, detailed data in an interpretable form. The author should compare and contrast the nuances of the case report with the published literature and should explain and justify the differences and similarities. The discussion section of a case report is in no way designed to provide comprehensive details of each citation of an all-inclusive and extensive literature review—this should be saved for review articles. All the references cited should be critically evaluated. Transferring an unread reference cited in another article is unethical and will place the author of the case report at risk of error and embarrassment.

The author should next summarize the essential features of the case report, justify why this case is unique, and draw recommendations and conclusions.

Based on the evidence reviewed in the discussion section, the author must provide a justified conclusion. The author must be careful not to make firm judgments and sweeping recommendations based on speculation, on limited and tenuous information, or on a few case reports. However, justifiable evidence-based recommendations should be stated. The author may suggest that clinicians be cognizant of the insight learned from the case or suggest heightened vigilance, prudent management, avoidance, further study before taking action, or new ideas for investigation. How the information discovered from the case report will apply to the author’s practice should be described. This section should be concise and not exceed one paragraph. Guidelines for writing patient case reports in a checklist format (Appendix B) can facilitate and enhance the manuscript writing process.

Patient case reports are valuable resources of new and unusual information that may lead to vital research and advances in clinical practice that improve patient outcomes. Case reports should contain an abstract and four sections—an introduction, case presentation, discussion, and conclusion. The introduction provides the subject, purpose, and merit of the case report and the strategy used for the literature review. The patient case presentation should be descriptive, organized chronologically, accurate, salient, and presented in a narrative form. The discussion should compare and contrast the case report’s findings with the literature review, establish a causal and temporal relationship, and validate the case with a probability scale. The literature review should be extensive and should support the justification of the case report. The discussion section should end with a brief summary of the case with rational recommendations and conclusions. The conclusion section must provide a brief conclusion with evidence-based recommendations.

Patient case reports are valuable resources of new and unusual information that may lead to vital research.

Publishable patient case reports include cases that:

Advance medical science and spawn research;

Describe rare, perplexing, or novel diagnostic features of a disease state;

Report therapeutic challenges, controversies, or dilemmas;

Describe a new surgical procedure;

Report how a drug can enhance a surgical procedure;

Teach humanistic lessons to the health care professional;

Review a unique job description of a health care professional that improves patient care;

Report new medical errors or medication errors;

Discover a device malfunction that results in patient harm;

Describe adverse effects and patient toxicity of a radiopaque agent;

Describe life-threatening adverse events;

Describe dangerous and predictable adverse effects that are poorly appreciated and rarely recognized;

Describe rare or novel adverse drug reactions;

Describe a therapeutic failure or a lack of therapeutic efficacy;

Describe rare or novel drug–drug, drug–food, or drug–nutrient interactions;

Report unlabeled or unapproved uses of a medication;

Explore the use of pharmacogenomics to manage diseases;

Use life-saving techniques not previously documented;

Use pharmacoeconomic principles that improve patient care;

Uncover barriers to patient adherence;

Discover an interaction between a drug and a laboratory test that yields a false-positive or false-negative result;

Describe the effect of drugs in pregnancy and lactation;

Detect novel pharmacokinetic or pharmacodynamic principles; and

Use technology to improve patient outcomes.

(The following checklist is comprehensive; some items may not apply to all types of case reports.)

I. Abstract

□ Introduction and objective.

□ Case report.

□ Discussion.

□ Conclusion.

II. Introduction

□ Describe the subject matter.

□ State the purpose of the case report.

□ Provide background information.

□ Provide pertinent definitions.

□ Describe the strategy of the literature review and provide search terms.

□ Justify the merit of the case report by using the literature review.

□ Introduce the patient case to the reader.

□ Make the introduction brief and less than three paragraphs.

III. Patient case presentation

□ Describe the case in a narrative form.

□ Provide patient demographics (age, sex, height, weight, race, occupation).

□ Avoid patient identifiers (date of birth, initials).

□ Describe the patient’s complaint.

□ List the patient’s present illness.

□ List the patient’s medical history.

□ List the patient’s family history.

□ List the patient’s social history.

□ List the patient’s medication history before admission and throughout the case report.

□ Ensure that the medication history includes herbals, vaccines, depot injections, and nonprescription medications, and state that the patient was asked for this history.

□ List each drug’s name, strength, dosage form, route, and dates of administration.

□ Verify the patient’s medication adherence.

□ Provide renal and hepatic organ function data in order to determine the appropriateness of medication dosing regimens.

□ List the patient’s drug allergy status, including the name of the drug (brand or generic) and the date and type of reaction.

□ List the patient’s adverse drug reaction history and the dates of the reaction.

□ Provide pertinent serum drug levels and include the time of each level taken and its relationship to a dose.

□ Provide the patient’s dietary history.

□ Provide pertinent findings on physical examination.

□ Provide pertinent laboratory values that support the case.

□ Provide the reference range for laboratory values that are not widely known or established.

□ List the completed diagnostic procedures that are pertinent and support the case.

□ Paraphrase the salient results of the diagnostic procedures.

□ Provide photographs of histopathology, roentgenograms, electrocardiograms, skin manifestations, or anatomy as they relate to the case.

□ Obtain permission from the patient to use the patient’s photographs, or follow institutional guidelines.

□ Provide the patient’s events in chronological order.

□ Ensure a temporal relationship.

□ Ensure a causal relationship.

□ Ensure that the patient case presentation provides enough detail for the reader to establish the case’s validity.

IV. Discussion

□ Compare and contrast the nuances of the case report with the literature review.

□ Explain or justify the similarities and differences between the case report and the literature.

□ List the limitations of the case report and describe their relevance.

□ Confirm the accuracy of the descriptive patient case report.

□ Establish a temporal relationship.

□ Establish a causal relationship.

□ Report the validity of the case report by applying a probability scale such as the Naranjo nomogram.

□ Summarize the salient features of the case report.

□ Justify the uniqueness of the case.

□ Draw recommendations and conclusions.

V. Conclusion

□ Provide a justified conclusion.

□ Provide evidence-based recommendations.

□ Describe how the information learned applies to one’s own practice.

□ List opportunities for research.

□ Ensure that this section is brief and does not exceed one paragraph.

Gottleib GJ, Rogoz A, Vogel JV et al. A preliminary communication on extensively disseminated Kaposi’s sarcoma in a young homosexual man. Am J Dermatopathol . 1981 ; 3 : 111 –4.

Douglas J, Munro J, Kitchin A et al. Pulmonary hypertension and fenfluramine. Br Med J . 1981 ; 283 : 881 –3.

Atanasson P, Weiss B, Schmid E et al. Pulmonary hypertension and dexfenfluramine. Lancet . 1992 ; 339 : 436 . Letter.

Weir EK, Reeve HL, Huang JM et al. Anorexic agents aminorex, fenfluramine, and dexfenfluramine inhibit potassium current in rat pulmonary vascular smooth muscle and cause pulmonary vasoconstriction. Circulation . 1996 ; 94 : 2216 –20.

Abenhaim L, Moride Y, Brenot F et al. Appetite-suppressant drugs and the risk of primary pulmonary hypertension. N Engl J Med . 1996 ; 335 : 609 –16.

DeBakey L, DeBakey S. The case report. I. Guidelines for preparation. Int J Cardiol . 1983 ; 4 : 357 –64.

McCarthy LH, Reilly KE. How to write a case report. Fam Med . 2000 ; 329 : 190 –5.

Naranjo CA, Busto U, Sellers EM et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther . 1981 ; 30 : 239 –45.

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Case report

Journal of Medical Case Reports welcomes well-described reports of cases that include the following:

  • Unreported or unusual side effects or adverse interactions involving medications.
  • Unexpected or unusual presentations of a disease.
  • New associations or variations in disease processes.
  • Presentations, diagnoses and/or management of new and emerging diseases.
  • An unexpected association between diseases or symptoms.
  • An unexpected event in the course of observing or treating a patient.
  • Findings that shed new light on the possible pathogenesis of a disease or an adverse effect.

Case reports submitted to Journal of Medical Case Reports should make a contribution to medical knowledge and must have educational value or highlight the need for a change in clinical practice or diagnostic/prognostic approaches. The journal will not consider case reports describing preventive or therapeutic interventions, as these generally require stronger evidence.

Authors are encouraged to describe how the case report is rare or unusual as well as its educational and/or scientific merits in the covering letter that accompanies the submission of the manuscript.

Any images should protect the patient’s anonymity as far as possible. Any photos or medical imaging should not show the patient's name, medical record number, or date of birth. Images should be cropped only to show the key feature. As per journal policy, JMCR does not consider images with patient faces or patient facial features. If an image of a face must be published, this should be cropped so that only the affected area is shown. 

Consent for publication is a mandatory journal requirement for all case reports . Written informed consent for publication must be obtained from the patient (or their parent or legal guardian in the case of children under 18, or from the next of kin if the patient has died). For more information, please see our editorial policies .

Patient ethnicity must be included in the Abstract under the Case Presentation section.

Reporting standards

For case reports, Journal of Medical Case Reports requires authors to follow the CARE guidelines . The CARE checklist should be provided as an additional files. Submissions received without these elements will be returned to the authors as incomplete.

The checklist will not be used as a tool for judging the suitability of manuscripts for publication in Journal of Medical Case Reports , but is intended as an aid to authors to clearly, completely, and transparently let reviewers and readers know what authors did and found. Using the CARE guideline to write the case report and completing the CARE checklist are likely to optimize the quality of reporting and make the peer review process more efficient.

Preparing your manuscript

The information below details the section headings that you should include in your manuscript and what information should be within each section.

Please note that your manuscript must include a 'Declarations' section including all of the subheadings (please see below for more information).

Title page 

The title page should:

  • "A versus B in the treatment of C: a randomized controlled trial", "X is a risk factor for Y: a case control study", "What is the impact of factor X on subject Y: A systematic review, A case report etc."
  • or, for non-clinical or non-research studies: a description of what the article reports
  • if a collaboration group should be listed as an author, please list the Group name as an author. If you would like the names of the individual members of the Group to be searchable through their individual PubMed records, please include this information in the “Acknowledgements” section in accordance with the instructions below
  • Large Language Models (LLMs), such as ChatGPT , do not currently satisfy our authorship criteria . Notably an attribution of authorship carries with it accountability for the work, which cannot be effectively applied to LLMs. Use of an LLM should be properly documented in the Methods section (and if a Methods section is not available, in a suitable alternative part) of the manuscript
  •  indicate the corresponding author

The Abstract should not exceed 350 words. Please minimize the use of abbreviations and do not cite references in the abstract. The abstract must include the following separate sections:

  • Background: why the case should be reported and its novelty
  • Case presentation: a brief description of the patient’s clinical and demographic details, the diagnosis, any interventions and the outcomes
  • Conclusions: a brief summary of the clinical impact or potential implications of the case report

Keywords 

Three to ten keywords representing the main content of the article.

The Background section should explain the background to the case report or study, its aims, a summary of the existing literature.

Case presentation

This section should include a description of the patient’s relevant demographic details, medical history, symptoms and signs, treatment or intervention, outcomes and any other significant details.

Discussion and Conclusions

This should discuss the relevant existing literature and should state clearly the main conclusions, including an explanation of their relevance or importance to the field.

List of abbreviations

If abbreviations are used in the text they should be defined in the text at first use, and a list of abbreviations should be provided.

Declarations

All manuscripts must contain the following sections under the heading 'Declarations':

Ethics approval and consent to participate

Consent for publication, availability of data and materials, competing interests, authors' contributions, acknowledgements.

  • Authors' information (optional)

Please see below for details on the information to be included in these sections.

If any of the sections are not relevant to your manuscript, please include the heading and write 'Not applicable' for that section. 

Manuscripts reporting studies involving human participants, human data or human tissue must:

  • include a statement on ethics approval and consent (even where the need for approval was waived)
  • include the name of the ethics committee that approved the study and the committee’s reference number if appropriate

Studies involving animals must include a statement on ethics approval and for experimental studies involving client-owned animals, authors must also include a statement on informed consent from the client or owner.

See our editorial policies for more information.

If your manuscript does not report on or involve the use of any animal or human data or tissue, please state “Not applicable” in this section.

If your manuscript contains any individual person’s data in any form (including any individual details, images or videos), consent for publication must be obtained from that person, or in the case of children, their parent or legal guardian. All presentations of case reports must have consent for publication.

You can use your institutional consent form or our consent form if you prefer. You should not send the form to us on submission, but we may request to see a copy at any stage (including after publication).

See our editorial policies for more information on consent for publication.

If your manuscript does not contain data from any individual person, please state “Not applicable” in this section.

All manuscripts must include an ‘Availability of data and materials’ statement. Data availability statements should include information on where data supporting the results reported in the article can be found including, where applicable, hyperlinks to publicly archived datasets analysed or generated during the study. By data we mean the minimal dataset that would be necessary to interpret, replicate and build upon the findings reported in the article. We recognise it is not always possible to share research data publicly, for instance when individual privacy could be compromised, and in such instances data availability should still be stated in the manuscript along with any conditions for access.

Authors are also encouraged to preserve search strings on searchRxiv https://searchrxiv.org/ , an archive to support researchers to report, store and share their searches consistently and to enable them to review and re-use existing searches. searchRxiv enables researchers to obtain a digital object identifier (DOI) for their search, allowing it to be cited. 

Data availability statements can take one of the following forms (or a combination of more than one if required for multiple datasets):

  • The datasets generated and/or analysed during the current study are available in the [NAME] repository, [PERSISTENT WEB LINK TO DATASETS]
  • The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
  • All data generated or analysed during this study are included in this published article [and its supplementary information files].
  • The datasets generated and/or analysed during the current study are not publicly available due [REASON WHY DATA ARE NOT PUBLIC] but are available from the corresponding author on reasonable request.
  • Data sharing is not applicable to this article as no datasets were generated or analysed during the current study.
  • The data that support the findings of this study are available from [third party name] but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are however available from the authors upon reasonable request and with permission of [third party name].
  • Not applicable. If your manuscript does not contain any data, please state 'Not applicable' in this section.

More examples of template data availability statements, which include examples of openly available and restricted access datasets, are available here .

BioMed Central strongly encourages the citation of any publicly available data on which the conclusions of the paper rely in the manuscript. Data citations should include a persistent identifier (such as a DOI) and should ideally be included in the reference list. Citations of datasets, when they appear in the reference list, should include the minimum information recommended by DataCite and follow journal style. Dataset identifiers including DOIs should be expressed as full URLs. For example:

Hao Z, AghaKouchak A, Nakhjiri N, Farahmand A. Global integrated drought monitoring and prediction system (GIDMaPS) data sets. figshare. 2014. http://dx.doi.org/10.6084/m9.figshare.853801

With the corresponding text in the Availability of data and materials statement:

The datasets generated during and/or analysed during the current study are available in the [NAME] repository, [PERSISTENT WEB LINK TO DATASETS]. [Reference number]  

If you wish to co-submit a data note describing your data to be published in BMC Research Notes , you can do so by visiting our submission portal . Data notes support open data and help authors to comply with funder policies on data sharing. Co-published data notes will be linked to the research article the data support ( example ).

All financial and non-financial competing interests must be declared in this section.

See our editorial policies for a full explanation of competing interests. If you are unsure whether you or any of your co-authors have a competing interest please contact the editorial office.

Please use the authors initials to refer to each authors' competing interests in this section.

If you do not have any competing interests, please state "The authors declare that they have no competing interests" in this section.

All sources of funding for the research reported should be declared. If the funder has a specific role in the conceptualization, design, data collection, analysis, decision to publish, or preparation of the manuscript, this should be declared.

The individual contributions of authors to the manuscript should be specified in this section. Guidance and criteria for authorship can be found in our editorial policies .

Please use initials to refer to each author's contribution in this section, for example: "FC analyzed and interpreted the patient data regarding the hematological disease and the transplant. RH performed the histological examination of the kidney, and was a major contributor in writing the manuscript. All authors read and approved the final manuscript."

Please acknowledge anyone who contributed towards the article who does not meet the criteria for authorship including anyone who provided professional writing services or materials.

Authors should obtain permission to acknowledge from all those mentioned in the Acknowledgements section.

See our editorial policies for a full explanation of acknowledgements and authorship criteria.

If you do not have anyone to acknowledge, please write "Not applicable" in this section.

Group authorship (for manuscripts involving a collaboration group): if you would like the names of the individual members of a collaboration Group to be searchable through their individual PubMed records, please ensure that the title of the collaboration Group is included on the title page and in the submission system and also include collaborating author names as the last paragraph of the “Acknowledgements” section. Please add authors in the format First Name, Middle initial(s) (optional), Last Name. You can add institution or country information for each author if you wish, but this should be consistent across all authors.

Please note that individual names may not be present in the PubMed record at the time a published article is initially included in PubMed as it takes PubMed additional time to code this information.

Authors' information

This section is optional.

You may choose to use this section to include any relevant information about the author(s) that may aid the reader's interpretation of the article, and understand the standpoint of the author(s). This may include details about the authors' qualifications, current positions they hold at institutions or societies, or any other relevant background information. Please refer to authors using their initials. Note this section should not be used to describe any competing interests.

Footnotes can be used to give additional information, which may include the citation of a reference included in the reference list. They should not consist solely of a reference citation, and they should never include the bibliographic details of a reference. They should also not contain any figures or tables.

Footnotes to the text are numbered consecutively; those to tables should be indicated by superscript lower-case letters (or asterisks for significance values and other statistical data). Footnotes to the title or the authors of the article are not given reference symbols.

Always use footnotes instead of endnotes.

Examples of the Vancouver reference style are shown below.

See our editorial policies for author guidance on good citation practice

Web links and URLs: All web links and URLs, including links to the authors' own websites, should be given a reference number and included in the reference list rather than within the text of the manuscript. They should be provided in full, including both the title of the site and the URL, as well as the date the site was accessed, in the following format: The Mouse Tumor Biology Database. http://tumor.informatics.jax.org/mtbwi/index.do . Accessed 20 May 2013. If an author or group of authors can clearly be associated with a web link, such as for weblogs, then they should be included in the reference.

Example reference style:

Article within a journal

Smith JJ. The world of science. Am J Sci. 1999;36:234-5.

Article within a journal (no page numbers)

Rohrmann S, Overvad K, Bueno-de-Mesquita HB, Jakobsen MU, Egeberg R, Tjønneland A, et al. Meat consumption and mortality - results from the European Prospective Investigation into Cancer and Nutrition. BMC Medicine. 2013;11:63.

Article within a journal by DOI

Slifka MK, Whitton JL. Clinical implications of dysregulated cytokine production. Dig J Mol Med. 2000; doi:10.1007/s801090000086.

Article within a journal supplement

Frumin AM, Nussbaum J, Esposito M. Functional asplenia: demonstration of splenic activity by bone marrow scan. Blood 1979;59 Suppl 1:26-32.

Book chapter, or an article within a book

Wyllie AH, Kerr JFR, Currie AR. Cell death: the significance of apoptosis. In: Bourne GH, Danielli JF, Jeon KW, editors. International review of cytology. London: Academic; 1980. p. 251-306.

OnlineFirst chapter in a series (without a volume designation but with a DOI)

Saito Y, Hyuga H. Rate equation approaches to amplification of enantiomeric excess and chiral symmetry breaking. Top Curr Chem. 2007. doi:10.1007/128_2006_108.

Complete book, authored

Blenkinsopp A, Paxton P. Symptoms in the pharmacy: a guide to the management of common illness. 3rd ed. Oxford: Blackwell Science; 1998.

Online document

Doe J. Title of subordinate document. In: The dictionary of substances and their effects. Royal Society of Chemistry. 1999. http://www.rsc.org/dose/title of subordinate document. Accessed 15 Jan 1999.

Online database

Healthwise Knowledgebase. US Pharmacopeia, Rockville. 1998. http://www.healthwise.org. Accessed 21 Sept 1998.

Supplementary material/private homepage

Doe J. Title of supplementary material. 2000. http://www.privatehomepage.com. Accessed 22 Feb 2000.

University site

Doe, J: Title of preprint. http://www.uni-heidelberg.de/mydata.html (1999). Accessed 25 Dec 1999.

Doe, J: Trivial HTTP, RFC2169. ftp://ftp.isi.edu/in-notes/rfc2169.txt (1999). Accessed 12 Nov 1999.

Organization site

ISSN International Centre: The ISSN register. http://www.issn.org (2006). Accessed 20 Feb 2007.

Dataset with persistent identifier

Zheng L-Y, Guo X-S, He B, Sun L-J, Peng Y, Dong S-S, et al. Genome data from sweet and grain sorghum (Sorghum bicolor). GigaScience Database. 2011. http://dx.doi.org/10.5524/100012 .

Figures, tables and additional files

See  General formatting guidelines  for information on how to format figures, tables and additional files.

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Case Report: A Beginner’s Guide with Examples

A case report is a descriptive study that documents an unusual clinical phenomenon in a single patient. It describes in details the patient’s history, signs, symptoms, test results, diagnosis, prognosis and treatment. It also contains a short literature review, discusses the importance of the case and how it improves the existing knowledge on the subject.

A similar design involving a group of patients (with the similar problem) is referred to as case series.

Advantages of case reports

Case reports offer, in general a fast, easy and cheap way to report an unusual observation or a rare event in a clinical setting, as these have very small probability of being detected in an experimental study because of limitations on the number of patients that can be included.

These events deserve to be reported since they might provide insights on some exceptions to general rules and theories in the field.

Case reports are great to get first impressions that can generate new hypotheses (e.g. detecting a potential side effect of a drug) or challenge existing ones (e.g. shedding the light on the possibility of a different biological mechanism of a disease).

In many of these cases, additional investigation is needed such as designing large observational studies or randomized experiments or even going back and mining data from previous research looking for evidence for theses hypotheses.

Limitations of case reports

Observing a relationship between an exposure and a disease in a case report does not mean that it is causal in nature.

This is because of:

  • The absence of a control group that provides a benchmark or a point of reference against which we compare our results. A control group is important to eliminate the role of external factors which can interfere with the relationship between exposure and disease
  • Unmeasured Confounding caused by variables that influence both the exposure and the disease

A case report can have a powerful emotional effect (see examples of case reports below). This can lead to overrate the importance of the evidence provided by such case. In his book Against Empathy: The Case for Rational Compassion , Paul Bloom explains how a powerful story affects our emotions, can distort our judgement and even lead us to make bad moral choices.

When a case report describes a rare event it is important to remember that what we’re reading about is exceptional and most importantly resist generalizations especially because a case report is, by definition, a study where the sample is only 1 patient.

Selection bias is another issue as the cases in case reports are not chosen at random, therefore some members of the population may have a higher probability of being included in the study than others.

So, results from a case report cannot be representative of the entire population.

Because of these limitations, case reports have the lowest level of evidence compared to other study designs as represented in the evidence pyramid below:

Pyramid representing the levels of evidence for each study design

Real-world examples of case reports

Example 1: normal plasma cholesterol in an 88-year-old man who eats 25 eggs a day.

This is the case of an old man with Alzheimer’s disease who has been eating 20-30 eggs every day for almost 15 years. [ Source ]

The man had an LDL-cholesterol level of only 142 mg/dL (3.68 mmol/L) and no significant clinical atherosclerosis (deposition of cholesterol in arterial walls)!

His body adapted by reducing the intestinal absorption of cholesterol, lowering the rate of its synthesis and increasing the rate of its conversion into bile acid.

This is indeed an unusual case of biological adaptation to a major change in dietary intake.

Example 2: Recovery from the passage of an iron bar through the head

This is an interesting case of a construction foreman named Phineas Gage. [ Source ]

In 1848, due to an explosion at work, an iron bar passed through his head destroying a large portion of his brain’s frontal lobe. He survived the event and the injury only affected 1 thing: His personality!

After the accident, Gage became profane, rough and disrespectful to the extent that he was no longer tolerable to people around him. So he lost his job and his family.

His case inspired further research that focused on the relationship between specific parts of the brain and personality.

  • Sayre JW, Toklu HZ, Ye F, Mazza J, Yale S.  Case Reports, Case Series – From Clinical Practice to Evidence-Based Medicine in Graduate Medical Education .  Cureus . 2017;9(8):e1546. Published 2017 Aug 7. doi:10.7759/cureus.1546.
  • Nissen T, Wynn R.  The clinical case report: a review of its merits and limitations .  BMC Res Notes . 2014;7:264. Published 2014 Apr 23. doi:10.1186/1756-0500-7-264.

Further reading

  • Case Report vs Cross-Sectional Study
  • Cohort vs Cross-Sectional Study
  • How to Identify Different Types of Cohort Studies?
  • Matched Pairs Design
  • Randomized Block Design

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Medical Case Report

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Medical Case Report is a research document that is created by the health care team that deals with a specific disease that includes the symptoms, the diagnosis, medical history, patient details, and the treatment. This document is very important for the health care industry because it will be used to further strengthen their medical knowledge and use as proof or evidence about the medical care they will provide to their patients.

This Medical Case Report shows the patient information, the chief complaint, current medical history, medication history, family history, physical examination, review of body systems, vital signs, current medical condition, diagnostic examinations, and treatment. This PDF template is utilizing the Input Table in order to display the data in a table format which makes it easier to read, compare, and understand. This PDF template also displays the name of the author of the document which is usually the assigned physician of the patient being described in the report.

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Every doctor needs to know about their patient's detailed medical history information. The Medical History Record PDF template is mostly used in order to provide significant information about the health history, care requirements, and risk factors of the patient to doctors.The Medical History Record PDF template provides crucial information required to decide a course of treatment. Also, the Medical History Record PDF template helps speed up emergency treatment. The Medical History Record form template is for collecting data from the patients' to set some examples of personal information, conditions that belong to the patients and patients' immediate relatives, symptoms that you are currently experiencing, medication, allergies, smoking, and alcohol consumption. Make sure to upgrade to one of our HIPAA friendly plans for enhanced security.

These templates are suggested forms only. If you're using a form as a contract, or to gather personal (or personal health) info, or for some other purpose with legal implications, we recommend that you do your homework to ensure you are complying with applicable laws and that you consult an attorney before relying on any particular form.

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Medical History Record PDF template is mostly used in order to provide significant information about the health history, care requirements, and risk factors of the patient to doctors. It is for collecting data from the patients.

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About Medical History Templates

Doctors and hospitals use a medical history of a patient to review his/her health history. It’s a very important part of their workflow to ensure they’re providing the best care and treatment. A patient’s medical history may include details about past diseases, illnesses running in the family, previous diagnoses, medical abstract, therapies, allergies, and medication. Yes, this is not the whole picture but with the help of a detailed medical history, doctors can see health patterns of patients over time at a glance.

Many hospitals rely on paper-based forms for this task. Others use online forms while some also use PDF forms. So, here’s a collection of PDF form templates that you can use as a starting point. There are a plethora of questions to be asked but what’s nice about using a template is the freedom to customize it. To top it all off, you get to start with beautiful and well-designed PDF templates, for free.

Privacy is also a key point to consider. The Health Insurance Portability and Accountability Act of 1996 (or HIPAA) is a United States legislation that provides data privacy and security provisions for safeguarding medical information. The good news? Jotform offers HIPAA compliance features and that’s a huge plus for anyone in the healthcare industry. So, aside from these PDF templates that were pre-built and designed for you, you also enjoy the advantages of using a platform that’s HIPAA-friendly.

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Medical Case Report

Medical Case Report featured

People who work in any kind of field or business know that reports are always going to be a part of that type of job. There is no denying it. Even when we work, we would still encounter reports in our daily lives. It is not something that a lot of people would like to see but it is a necessity, even to those who work in the medical field. Reports are merely part of the paperwork they have to go through on a daily if not weekly basis. This would depend on what is given to you or what you need to write from it. Some people can tell you that a medical report can either give you the best news or the worst news.

It is not only the fact that it is necessary , but it is also a way for them to be able to know, to be able to know the status of a patient, their medical history, and their medical status in general. Of course, not all medical case reports show this information, as some of the case reports handed over to their head are a summary of the whole report. This of course does not mean that the summary is not as helpful as the original case report; it is always best to know the whole story or the whole nine yards than to just simply get the shorter version of it.

10+ Medical Case Report Examples

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consent form for medical case report

Size: 166 KB

3. Medical Error Case Report

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medical patient consent for case report

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5. Medical Case Study Report

medical case study report

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6. Coronavirus Disease Case Report Form

coronavirus disease case report form

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7.  Conference on Medical Case Report

conference on medical case report

Size: 468 KB

8. Sample Medical Case Report Policy

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9. Medical Confidential Case Report

medical confidential case report

Size: 47 KB

10. Medical Autopsy Case Report

medical autopsy case report

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11. Medical Case Report Authorization Form

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What Is a Medical Case Report?

A medical case report or simply called a case report is a kind of documented report that shows very detailed information . Sometimes, it can also be a very detailed summary of a person’s medical status. This means this report contains the symptoms, the diagnosis, the treatment if there are any, and the history of medications taken by the person. It can also be used for those patients who were already diagnosed and would want to have a second opinion on the diagnosis. In addition to that, a medical case report also acts as notes for those patients who are going to go through a follow-up after being diagnosed or treated for their problems. 

The purpose of a medical case report is to take down what is going on with the patient  to assess the issues that the patient is talking about. For those who are studying new cases of illnesses, the medical reports are used as a tool to be able to conduct a study and to be able to know more about it. 

How to Write a Medical Case Report?

When it comes to report writing, we know that being meticulous is the best way to go. But what if you are writing a medical case report? Is being meticulous the only way to go? To know more about the ways to write this case report, check out the tips below.

1. Always Be Clear and Concise

In  writing medical reports , anyone in the medical field will tell you that it can be tricky if you do not understand what you are writing about. To get your point across, make sure to keep your report clear and concise. Talk about a single topic and explain it in a specific manner. Avoid talking about multiple topics that would make your report confusing and difficult to decipher.

2. Avoid Any Erasures in Your Report

Erasures make your report unprofessional. This is why a lot of people tend to listen, understand, and think before they write . Not only are they avoiding any erasures, but they are also avoiding any issues that go with them. Any error found in your report can cause a huge risk to the patient, to your studies, and to the report in general.

3. Keep Your Facts Straight

It goes without saying that when writing medical journals or medical reports, the best thing to do is to keep your facts true and straight. Avoid writing information that is not true to your study or true to your patient. Making up new things to make it sound or look interesting is not the whole point of your report. This can also lead to a lot of problems in the future. Keep everything true and clear.

4. Use Simple Words

Difficult jargon should be avoided when writing your medical journal or your case report . Not everyone understands the jargon you may be using even if you may be talking about medical terms. The best way to avoid any issues with your colleagues and patients is to use simple words. You need not have to sound fancy to tell them what is wrong or to write what you are talking about. Of course, if you plan to use jargon familiar to your field, at least explain it.

5. Review Your Medical Case Report

Before handing it over to your head or to the person in charge, review what you may have written. Mistakes make the report unprofessional, with that said, try as much as possible not to do so. Check every paragraph or every sentence to see that you have your information to a tee, no stone left unturned as they would say.

What is a medical case report?

A medical case report or a case report is a document that is centered around studying new medical problems, the medical history of a patient, and the summary of the medical status of a patient.

Why is a medical case report so important?

The reason why it is so important is that it gives doctors and medical practitioners the information that they need.

Who writes the medical case report?

Doctors, nurses, and those who take up medical fields are often the ones who are told to write a medical case report.

It goes without saying regardless of what work we take up, we would always be writing up reports. This is especially true for those in the medical field. Medical reports help them understand more about the issue of a patient. It is through medical reports that they are able to understand and explain the new diseases that are discovered as well as it is in medical reports that they are able to find solutions for issues and to be able to help diagnose patients with rare conditions.

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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

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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

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Example of a poorly designed case report form

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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”.

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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.

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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.

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