This is an application from the Center for Clinical Epidemiology and Biostatistics (CCEB) at the University ofPennsylvania Medical Center to serve as the Scientific and Data Coordinating Center (CRI-SDCC) for the ProspectiveCohort Study of Chronic Renal Insufficiency. Chronic renal insufficiency (CRI) affects over 10 million Americans. Theirburden of morbidity derives from their frequent progression to end-stage renal disease (ESRD) and disproportionate risk ofcardiovascular events. A shared set of etiological factors is being identified as potentially responsible for both progressiverenal disease and cardiovascular disease (CVD). These include clinical characteristics and biomarkers (e.g.,physiologicalmeasures, circulating humoral factors, and genotypes). Characterizing relationships between these risk factors andoutcomes will permit development of instruments to predict poor outcomes in patients with CRI and enhanceunderstanding of etiological mechanisms leading to these outcomes. Activities focused on prediction and mechanisms ofprogressive renal disease and cardiovascular events in patients with CRI will be the primary tasks of the NIDDK CRIResearch Network (CRIRN) and the overall goals in this proposal for a CRI-SDCC for the CRIRN. In meeting thesegoals, the CRI-SDCC will provide scientific and logistical coordination for the CRIRN. Expertise in the CRI-SDCC willspan the range of etiological factors the CRIRN will explore and complement expertise among investigators at the ClinicalCenters (CCs) and the NTH. The CRI-SDCC will provide scientific coordination to ensure the CRIRN identifies andpursues the most salient issues facing the CRI population. The logistical coordination provided by the CRI-SDCC willemploy its extensive experience as a DCC and techniques from prior successful multi-institutionalcohort research thatincorporate state-of-the-art World Wide Web-based coordination of data/specimen collection, quality assurance, and dataanalysis. Broadly, the specific aims for the CRI-SDCC are to assist in collaboratively setting the scientific agenda of theCRIRN and to provide logistical coordination to implement the cohort study. Specifically, the SDCC will: 1: Contributecontent (e.g., renal epidemiology, nephrology, and cardiology) expertise and share scientific leadership of the CRIRNthrough the Steering and Planning Committee as it identifies and prioritizes specific areas of investigation and later refinesand modifies the CRIRN's scientific direction based on interim analyses and emerging scientific knowledge; 2: Develop acohort study design, protocol, and analysis plan for the CRIRN's chosen areas of study and studies beyond the initial scopeof its research activities; 3: Form and establish a Collaborative CRI Research Network (CRIRN), its Steering and PlanningCommittee, and coordinate communication and logistics for its meetings; 4: Develop a World Wide Web-based datamanagement system; 5: 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, andmanuscripts.
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