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

P* 科学与数据协调中心 (SDCC)

• 批准号: 7293891
• 负责人: HAROLD I FELDMAN
• 金额: $ 89.43万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-28 至 2008-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7293891
• 关键词: Internet; cardiovascular disorder; chronic renal failure; clinical research; comorbidity; cooperative study; data collection methodology /evaluation; data management; disease /disorder etiology; epidemiology; experimental designs; human morbidity; human subject; information systems; statistics /biometry

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.

描述（由申请人提供）： 这是一份来自临床流行病学中心的申请， 宾夕法尼亚大学医学中心的生物统计学（CCEB）， 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（CRI） 影响了超过一千万美国人他们的发病率负担来自于他们的 经常进展为终末期肾病（ESRD）， 心血管事件的风险。一组共同的病因因素正在被 被确定为可能导致进行性肾病和 心血管疾病（CVD）。这些包括临床特征， 生物标记（例如，生理措施，循环体液因子，和 基因型）。描述这些风险因素之间的关系， 结果将允许开发工具来预测不良结果， CRI患者并增强对病因机制的了解， 这些结果。活动侧重于预测和机制 CRI患者的进展性肾脏疾病和心血管事件将 是NIDDK CRI研究网络（CRIRN）的主要任务， 这是CRIRRN的CRI-SDCC提案中的目标。为了实现这些目标， CRI-SDCC将为CRIRN提供科学和后勤协调。 CRI-SDCC的专业知识将涵盖CRIRN的病因因素范围 将探索和补充临床研究人员的专业知识， 中心（CC）和NIH。CRI-SDCC将提供科学协调， 确保CRIRN识别并解决CRI面临的最突出问题 人口CRI-SDCC提供的后勤协调将使用 其作为DCC的丰富经验和以前成功的技术 多机构队列研究，包括最先进的世界 基于万维网的数据/标本收集、质量保证和 数据分析总的来说，CRI-SDCC的具体目标是协助 合作制定CRIRN的科学议程，并提供 后勤协调，以实施队列研究。具体而言，SDCC 将：1：贡献内容（例如，肾脏流行病学、肾脏病学，以及 心脏病学）专业知识，并通过 指导和规划委员会确定具体领域并确定其优先次序 调查和后来完善和修改CRIRN？的科学 根据中期分析和新出现的科学知识确定方向; 2： 为CRIRN？制定队列研究设计、方案和分析计划S 选定的研究领域和初步研究范围以外的研究 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：开发一个基于万维网的数据管理系统; 制定全面数据管理计划所需的所有材料; 6： 建立CRIRN范围内的质量保证标准和做法; 7： 协调摘要、专业材料和手稿。