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NUHS Guidance for Case Reports/Case Series

Case reports generally involve the collection and presentation of detailed information about a particular patient (or a small group of patients with similar characteristics for a case series) to highlight an interesting condition, treatment, or outcome. Case reports/Case series are categorized as observational but only descriptive studies (as opposed to analytical studies) that do not meet the definition of Research according to the Code of Federal Regulations:

Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge [45 CFR46.102(d)].

This guidance is intended to assist an investigator preparing a case report or case series to determine if a study is research that requires IRB review. Completed Guidance should be submitted to the NUHS Research Coordinator.

Case Report Information

1. Title:


2. Principal Author
Name, academic/professional degree(s) and Master’s program (if applicable)


Signature and Date:


Date of most recent IRB approved training for the Protection of Human Subjects from Research Risks:


Telephone number: Email:

Co-Author or Faculty Sponsor
Name, academic/professional degree(s):


Signature and Date:


Date of most recent IRB approved training for the Protection of Human Subjects from Research Risks:


Telephone number: Email

Additional Co-Authors:
Name, academic/professional degree(s):


Signature and Date:


Date of most recent IRB approved training for the Protection of Human Subjects from Research Risks:


Telephone number: Email

3. Overview – a brief description including*:
• Rationale for this case report
• Presenting concerns of the patient
• Diagnosis/interventions/outcomes
• Main lessons learned


* templates for writing a case report and examples of case reports can be found at CARE, the website for Case reports: http://www.care-statement.org/index.html


4. To determine if this case report needs IRB review, answer all of the following questions:


• Is any patient identifier (patient medical identifier/PMI) included in the report? Yes No


• Are statistics being used in a manner to allow extrapolation to a larger population? Yes No


• Is the intervention considered experimental for the condition? Yes No


• Is the patient(s) considered a special population (such as children, prisoners, cognitively impaired)? Yes No


• Are incentives being offered to the patient(s) (e.g. compensation, free treatments or diagnostic tests)? Yes No


• Are interventions added to the treatment to enhance the case report (such as, additional treatments, diagnostic work, or questionnaires)? Yes No


If you answered “yes” to any of these questions, please contact the Chair of NUHS IRB or NUHS Research Coordinator


5. Types of Consent

Consent to Treat is typically obtained from all patients undergoing medical care regardless of the outcome of treatment. It is generic and does not specify conditions or treatments.


If the project is categorized as research (particularly prospective projects) Informed Consent will be required by IRB. Informed consent provides details of the purpose of the study, the condition being treated, the intervention planned, and any alternative treatment options available for the patient.


If you plan to submit your case report for publication, the journal may require Consent to Publish (each journal has a specific form, check journal’s instructions to authors). This consent gives the journal permission to publish the patient’s medical information.

Principal Author Assurance
I have read this Guidance for Case Reports and according to the Federal definition of Research; my project is not research and thereby does not fall under Institutional Review Board guidelines. I understand that the intervention(s) used in this case study/series are dictated by standard clinical reasoning for the patient situation(s). Any intervention beyond usual and customary may change the classification of this project to research. If this occurs, I will stop all further intervention until such time as the needed IRB approval is obtained




Signature Print Name Date



Research Coordinator or IRB Designee
I have reviewed the project and agree that project should be exempt from IRB Guidelines.



Signature Print Name Date



Submit completed Guidance and all related documents to NUHS Research Coordinator.

How to summary a case study? Determine the most crucial details of the case at hand. The first step to a successful case study analysis is to study the information carefully. ... Pinpoint the main issues and concerns. In many case studies, there is usually more than one issue present. ... Think of different solutions. ... Critically assess those solutions. ... Decide which plan of action to take. ...