Year One - Margo
Margo is a resident in the Cardiology department and she has begun working on her research project. She met with her mentor to discuss possible questions that their department/clinic would have enough data to sufficiently answer. Margo and her mentor decide to study the effect of anti-hypertensive drugs on the risk of myocardial infarctions. In order to study this effect Margo decides to use a case-control study design in which the cases are hypertensive patients who have suffered from a first fatal or nonfatal myocardial infarction. The controls are a stratified random sample of hypertensive patients who have never suffered from a myocardial infarction, matched on gender, age, and smoking status. Margo formulates a list of the variables needed for this study and is ready to determine if there are enough patients that have come through the clinic with these characteristics to make her study feasible.
Now that Margo has a research topic in mind she needs to determine if there is enough data available. Without IRB approval it is not possible for Margo to gather the data, however the medical center she works at has a Cohort Discovery tool. This tool will allow her to get a rough estimate of the number of cases and potential controls. Once Margo has established the feasibility of her project she begins formulating her proposal to the IRB. It is a good guideline for Margo to have her IRB proposal submitted by the end of her first year of research.
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-- ErinEsp - 07 May 2012