Retrospective cohort study protocol template - application

Sep 1, 2026

Retrospective cohort study protocol template for chart-review designs that evaluate outcomes using previously accumulated data. The document supports comparing groups defined by treatment exposure and determining whether outcomes differ between groups. It guides investigators in completing an application for IRB review and exempt determination, including sections for title, investigators, version and date, significance/background, objectives, primary and secondary outcomes, setting/resources, subjects, study procedures, statistical plan, and data confidentiality.

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Retrospective cohort study protocol template - application

Title and investigator information

Significance/Background and objectives

Outcome variables and study setting

Study design, subjects, and procedures

Statistical plan and data confidentiality

This template is for a Retrospective cohort study design (some type of chart review where your research question only addresses previously accumulated data). Use this template if you intend on comparing groups by treatments and determining if outcomes are different between the groups. The IRB will use this protocol to make their exempt determination. Please reference sections in this document to complete the application. Title (Descriptive title; keep it tight, no 100 word titles) Investigators: Version Date (e.g., the date the protocol was created) Significance/Background: Using the literature, establish any previous work related to your research question. This section should describe the gaping hole in the literature and how your specific aims will attempt to address it. Make sure to cite your references in this section! Example: The controversy surrounding motorcyclist helmet use has been a long-standing dispute between government, motorcyclists, and medical providers. Since 1966, the year Congress initially enacted helmet use legislation, intense lobbying efforts by motorcyclist activists have overturned legislation stating mandatory helmet laws encroach on personal freedoms of riders. By 1975, only 50% of the United States still had a universal helmet law (1). There has been growing evidence to support mandatory helmet laws to increase helmet use compliance among motorcyclists, and lack of such laws decreases helmet usage. Costs incurred from unhelmeted motorcyclists have been shown to be substantially larger, with a difference of approximately $250 million dollars in medical costs as compared to helmeted riders nationwide (2). Despite efforts of the government and medical literature supporting mandatory use of helmets among motorcyclists, state legislatures have continued to enact partial and no helmet laws for riders (3). After 35 years of requiring riders to remain helmeted at all times, on April 13, 2012 Michigan joined many states by enacting a partial helmet law (4). This study intends to investigate the trend of motorcycle crash injuries, including the morbidity and fatality of riders among other variables in the months following Michigan’s change in helmet use legislation. Objective(s): Identify the specific aim(s) for your study. Example: To determine the impact of the motorcycle helmet law on clinical outcomes among motorcycle crash victims in the state of Michigan. Primary Outcome Variable(s): Describe any primary outcome variables for the study. Example: Mortality, length of stay Secondary Outcome Variable(s), if applicable: Describe any secondary outcome variables for the study. Example: Injury severity score, length of ICU stay, time on ventilator, cost, payer, alcohol and/or drug use, and disposition Setting/Resources for the Study: Describe where the research will take place. This includes both the setting for the research, as well as the location of any of the patient records to be obtained. Example: The setting for this research is General Hospital. The electronic medical record will be accessed by the investigators to obtain the necessary information. Study Design: Describe the study design. Example: Retrospective cohort study Study Subjects: Describe where you will obtain your subjects, over what time period and the specific inclusion and exclusion criteria used. Example: All patients admitted to the trauma service at General Hospital involved in a motorcycle crash as the driver or passenger between 04/11/11 and 11/15/11 (prior to no helmet law) and between 04/11/12 and 11/15/12 (five months following no helmet law). Patients with no documentation of helmet use will be excluded from the study. Study Procedures: This section basically describes methods for obtaining your data and descriptions/definitions of your variables. If you plan to request a report from the hospital, you may consider contacting the clinical informatics department to explore feasibility. Depending on the complexity

FAQs

When should this retrospective protocol template be used?

Use it for retrospective cohort designs where the research question relies on previously accumulated data and compares groups based on treatment exposure and outcomes.

What IRB-related purpose does the protocol serve?

The IRB uses the completed protocol to support an exempt determination, provided the application is filled out using the referenced sections.

What sections does the template require to describe the study?

It includes background/significance, objectives, primary and secondary outcome variables, setting/resources, study design, study subjects with inclusion/exclusion criteria, study procedures, statistical methods and sample size determination, and confidentiality/data management.

Sep 1, 2026

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