This is an application from the Center for Clinical Epidemiology and Biostatistics (CCEB) at the University of Pennsylvania Medical Center to serve as the Scientific and Data Coordinating Center (CRI-SDCC) for the Prospective Cohort Study of Chronic Renal Insufficiency. Chronic renal insufficiency (CRI) affects over 10 million Americans. Their burden of morbidity derives from their frequent progression to end-stage renal disease (ESRD) and disproportionate risk of cardiovascular events. A shared set of etiological factors is being identified as potentially responsible for both progressive renal disease-and cardiovascular disease (CVD). These include clinical characteristics and biomarkers (e.g., physiological measures, circulating humoral factors, and genotypes). Characterizing relationships between these risk factors and outcomes will permit development of instruments to predict poor outcomes in patients with CRI and enhance understanding of etiological mechanisms leading to these outcomes. Activities focused on prediction and mechanisms of progressive renal disease and cardiovascular events in patients with CRI will be the primary tasks of the NIDDK CRI Research Network (CRIRN) and the overall goals in this proposal for a CRI-SDCC for the CRIRN. In meeting these goals the CRI-SDCC will provide scientific and logistical coordination for the CRIRN. Expertise in the CRI-SDCC will span the range of etiological factors the CRIRN will explore and complement expertise among investigators at the Clinical Centers (CCs) and the NIH. The CRI-SDCC will provide scientific coordination to ensure the CRIRN identifies and pursues the most salient issues facing the CRI population. The logistical coordination provided by the CRI-SDCC will employ its extensive experience as a DCC and techniques from prior successful multi-institutional cohort research that incorporate state-of-the-art World Wide Web-based coordination of data/specimen collection, quality assurance, and data analysis. Broadly, the Specific Aims for the CRI-SDCC are to assist in collaboratively setting the scientific agenda of the CRIRN and to provide logistical coordination to implement the cohort study. Specifically, the SDCC will: 1: Contribute content (e.g., renal epidemiology, nephrology, and cardiology) expertise and share scientific leadership of the CRIRN through the Steering and Planning Committee as it identifies and prioritizes specific areas of investigation and later refines and modifies the CRIRN?s scientific direction based on interim analyses and emerging scientific knowledge; 2: Develop a cohort study design, protocol, and analysis plan for the CRIRN?s chosen areas of study and studies beyond the initial scope of its research activities; 3: Form and establish a Collaborative CRI Research Network (CRIRN), its Steering and Planning Committee, and coordinate communication and logistics for its meetings; 4: Develop a World Wide Web-based data management system; S: Develop all materials required for a comprehensive data management plan; 6: Establish CRIRN-wide quality assurance standards and practices; 7: Prepare and coordinate abstracts, professional materials, and manuscripts.
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