This proposal to serve as the Research Coordinating Unit (RCU) for what we envision as the NHBLI Centers for Cardiovascular Outcomes Research Program (CCORP) is from the Collaborative Studies Center (CSC) and the Center for Outcomes and Effectiveness Research and Education (COERE) of the University of Alabama at Birmingham Division of Preventive Medicine. While requiring much of what is available from the operations of a typical coordinating center, the CCORP presents challenges in that it covers the rather broad topic of CVD outcomes research and the nature of the research to be done is unknown at the time of proposal preparation. This means that a successful RCU must have broad expertise in CVD and outcomes research and must have the facility and personnel resources to provide high quality and timely but also highly adaptive support for Program activities. Also, the ability of the CCORP as a whole and of the RCU in particular to leverage collaborations within the CCORP as well as more broadly within the CVD outcomes community will play a critical part in maximizing its impact. The proposed CSC RCU team and its overall facility and personnel resources are unusually well suited for this task. The leadership, Drs. Person, Williams and Lewis has some 50 person years of CC experience over numerous CVD and outcomes research projects, several of which focused on CVD outcomes research. It also has some 15 additional years of experience with field center and clinical centers for large scale clinical trials and observational studies as a consequence of Dr. Lewis's leadership in this area. Further, the overall resources and facilities of the CSC have been created over the past 15 years specifically for projects such as this and thus is especially well suited for the CCORP challenges. Our general aim is to work closely with the centers, study committees, and NHLBI staff to provide RCU support as required for the CCORP to thrive.
Our specific aims i nclude providing an excellent infrastructure for study management;serving as a resource in outcomes research, cost effectiveness, data sources, statistical analyses, quality assurance plans and control systems, data management and security;and developing comprehensive metrics for evaluating the Program as a whole.
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