Introduction
Project TitleStudy TeamAll study team members are required to complete CITI training. Be sure that all training is up-to-date, and enter expiration dates in the study team section on Velos.Principal Investigator:Co-Investigator:Other Key Personnel:Lay Language SummaryA brief (200 words or less) description of your project featuring research question, significance, design, and outcome determination.Background and Scientific SignificanceWhat work exists that has led up to your research question? Has anything similar been done before? How would your work contribute to the knowledge base and possibly affect clinical practice? Do not exceed one page. Do not paste information directly from a grant or grant application. Use no more than ten references and list the references in the reference section below.Specific AimsSpecific aim(s) is(are) the objective(s) of your research – what you want to accomplish. Specific aim(s) should be driven by your hypothesis. Do not paste directly from a grant or grant application.Study DesignWhat type of study are you designing? Cohort, case-controlled, case series, interventional? How is the study designed to answer your hypothesis and specific aim(s)? Describe any study groups, arms, or cohorts. Include all procedures, including any randomization.. Do not paste directly from a grant or grant application. Study ProceduresInclude all procedures. A table or flowchart of the study design may be included for clarification purposes of the schedule of events/visits. Outcome Measures and Study EndpointsHow will the results be interpreted? How will your outcomes be measured and at what point?Analyses and Statistical MethodologyThis is important. You will want to consult with a statistician on this part. You want to reduce confounding variables, particularly in retrospective studies. A statistician will help you do this. Also, the statistician can help you determine the desirable study population and design outcome measures that will lend themselves to statistical inference.ReferencesPertinent references should be listed. Make sure your study has not already been done recently. If so, you must explain why your study is different and should be done. ................
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