Visiting Graduate Student (unpaid)

Overview of Department & Mentor

•    Dr. Raj Makkar, is an internationally renown interventional cardiologist.
Dr Makkar’ s Research Group Activity:
 -Our heart valve and  heart structural research program is well-known  in the country by its important contributions to innovations and novel clinical research studies..
-Our Studies generated numerous scientific papers in the most prestigious medical journals (The New England of Medicine, JAMA, Lancet).

Role Summary & Objectives
This appointment will provide guidelines and knowledge to the scholar about obtaining the relevant data that will later be used as a base of new ideas and contributions to Retrospective or prospective  studies and publications. 
It will require obtaining the Good Clinical Practice and accreditation for the IRB research studies that he will 
be assigned to.
 The intern/scholar will be able to understand how process data mining, how we manage and analyze the data on our specific structural heart registry studies. The work may serve as subject for future abstract of manuscripts.
Role Activities & Timeline 
The visiting scholar will be designated to a specific research project or registry. You will take all necessary modules to obtain IRB approvals. He will collect data and participate to completion of the project as well as contribution to the potential publication(s). 
His activity will be strict research. 
He will not be allowed to be shadowing in the clinic or to have observation duties in the cath lab.
The visiting scholar will be able to understand how we subtract data, how we manage and analyze the data on our own retrospective registry studies.
The proposed study is about Align Study: IRB 44753 results (based on our enrolled subjects) when compared to a Registry study on using an off label commercially approved valve in patients with severe Aortic insufficiency.
we propose to set up a retrospective cohort study to evaluate the outcomes in patients with severe AR who were treated with an off-label valve. Patient’s baseline clinical characteristics, echocardiographic characteristics, hemodynamics from cardiac catheterization, CT scans, MRI, and other imaging studies will be reviewed in a retrospective manner from preexisting medical records with the purpose of analyzing outcomes in these patients.
The scholar will access only data related to the Protocol registry study IRB 44753
He will participate to bi-weekly meeting that will be able to measure the activity and assess the objective of the project.

Week1-2: HR mandated training
Week 2-4: Learn about regulatory aspects and how a large clinical trial is structured and conducted
Week 4-6: Student will learn about the process that goes into screening and selecting potential subjects and how data management is conducted. 
            Week 6-12: Student will work closely with Dr. Makkar and the research team to analyze the data and learn how to prepare an abstract