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2014-643 EMS - UNC Heart and Vascular Center - Data Use Agreement
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2014-643 EMS - UNC Heart and Vascular Center - Data Use Agreement
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9/25/2014 4:07:33 PM
Creation date
9/25/2014 4:07:24 PM
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BOCC
Date
9/25/2014
Meeting Type
Work Session
Document Type
Agreement
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Objective <br /> We propose to collect data on SUD victims in North Carolina in order to determine t1-,le rate of <br /> sudden unexplained death by gender, race and socioeconomic class in NC. Further, vie will <br /> evaluate the collected data to develop a risk stratification tool in order to improve the screening <br /> process for patients at risk for sudden unexplained death. <br /> Methods <br /> Beginning March 1, 2013 all residents of Wake County North Carolina that undergo sudden <br /> unexplained death will be ascertained from emergency medical services,the medical examiner, <br /> and emergency rooms of area hospitals. A comprehensive evaluation will be performed, <br /> including analysis of circumstances of death, medical records, and available autopsy data. A <br /> DNA swab will be done on all candidates. An independent adjudication committee will <br /> determine if subjects meet study criteria for sudden unexplained death. An independent lab will <br /> perform DNA analysis. Annual incidence rates will be calculated for all residents and <br /> demographic subgroups; complete phenotyping will be done on all subjects. The program will be <br /> expanded to 36 other counties in North Carolina in the near future. <br /> If your study protocol changes in such a way that this determination will no longer apply, you <br /> should contact the above IRB before making the changes. <br /> CC: Irion Pursell, Heart and Vascular Center <br /> 5 <br />
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