Scientific and Data Coordinating Center(SDCC) for the P*

描述(由申请人提供)： 这是来自临床流行病学中心的一份申请 生物统计学(CCEB)在宾夕法尼亚大学医学中心服务 作为未来科学和数据协调中心(CRI-SDCC) 慢性肾功能不全的队列研究。慢性肾功能不全 影响了1000多万美国人。他们的患病负担来自于他们的 经常进展为终末期肾病(ESRD)并不成比例 心血管事件的风险。一组共同的致病因素正在 被认为是进行性肾脏疾病的潜在原因--和 心血管疾病(CVD)。这些包括临床特征和 生物标志物(例如，生理指标、循环体液因子和 基因分型)。描述这些风险因素和 结果将允许开发预测不良结果的工具 提高对CRI患者发病机制的认识 对这些结果的反应。以预测和机制为重点的活动 慢性肾衰患者的进展性肾脏疾病和心血管事件 是NIDDK CRI研究网络(CRIRN)的主要任务 本提案中的目标是为CRIRN建立CRI-SDCC。为了实现这些目标， CRI-SDCC将为CRIRN提供科学和后勤协调。 CRI-SDCC方面的专业知识将跨越CRIRN的病因范围 将探索和补充临床研究人员的专业知识 中心(CCS)和国家卫生研究院。CRI-SDCC将提供科学协调，以 确保CRIRN识别和处理CRI面临的最突出问题 人口。由CRI-SDCC提供的后勤协调将使用 作为DCC的丰富经验和以前成功的技术 结合世界最先进技术的多机构队列研究 基于万维网的数据/样本收集、质量保证和 数据分析。总体而言，CRI-SDCC的具体目标是协助 协作制定CRIRN的科学议程，并提供 实施队列研究的后勤协调。具体地说，国家发改委 意愿：1：贡献内容(例如，肾脏流行病学、肾脏病和 心脏病学)专业知识和分享CRIRN的科学领导通过 指导和规划委员会确定并确定具体领域的优先次序 的调查，后来提炼和修改了CRIRN？S科学 基于中期分析和新兴科学知识的方向；2： 为CRIRN制定队列研究设计、方案和分析计划--S 选定的研究领域和超出其初始研究范围的研究 活动；3：组建和建立CRI合作研究网络(CRIRN) 其指导和规划委员会，并协调通信和后勤 4：开发基于万维网的数据管理系统；S： 制定全面数据管理计划所需的所有材料；6： 建立CRIRN范围的质量保证标准和做法；7：准备和 协调摘要、专业材料和手稿。

DESCRIPTION(provided by applicant): 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.