Prospective renal insufficiency cohort evaluation: PRICE

描述(由申请人提供)： 2003-2007年间，前瞻性慢性肾功能不全队列(CRIC)研究招募了3400名患有慢性肾脏疾病的成年人，通过最初5年的随访，确定肾脏疾病快速进展的预测因素，并澄清肾功能障碍与亚临床和临床心血管事件、死亡和资源利用之间的关系。拟议的第二次审评委后续行动延长至2013年，提供了一个独特的机会，可以利用审评委第一次会议的现有努力和成功，建立一批慢性肾脏疾病参与者，他们对肾脏疾病的进展和各种不同的结果进行长期的前瞻性后续行动。这一无与伦比的资源还将扩大与慢性肾脏疾病自然史相关的科学，以及对心血管疾病和其他不良事件的影响。宾夕法尼亚大学临床中心要解决的具体目标是：1.将高比例的CRIC第一阶段参与者重新登记到CRIC 2的第二阶段。根据CRIC第一阶段和第二阶段方案收集暴露和结果数据。3.在研究中保持高水平的保留率。4.调查自我报告的临床事件，并获得支持的医疗记录和文件。5.输入数据和处理/运送生物标本。6.实施当地质量保证和质量控制程序，作为获得标准化、高质量测量的一种手段7.监测数据收集、数据输入和随访率8.通过研究范围的小组委员会和活动参与对审评委研究的管理和监督9.发表和介绍审评委研究结果10.促进和支持审评委进行辅助研究，包括与更广泛的肾病学研究界合作。在这份申请中，我们将概述我们的网站如何履行其在第一阶段的义务，特别是如何为CRIC的辅助研究做出贡献。

DESCRIPTION (provided by applicant): Between 2003-2007, the prospective Chronic Renal Insufficiency Cohort (CRIC) Study enrolled >3400 adults with chronic kidney disease to address overarching goals of identifying predictors of rapid progression of kidney disease and clarifying the relationship between kidney dysfunction and the risks of subclinical and clinical cardiovascular events, death, and resource utilization through an initial 5-year follow-up. The proposed CRIC-2 extended follow-up through 2013 offers a unique opportunity to leverage the existing effort and success of CRIC-1 to establish a cohort of participants with chronic kidney disease who have long-term prospective follow-up on progression of kidney disease and a variety of different outcomes. This unparalleled resource will also expand the science related to chronic kidney disease natural history as well as the impact on cardiovascular disease and other adverse events. Specific Aims to be addressed by the University of Pennsyvania Clinical Center are: 1. To re-enroll a high percentage of CRIC Phase 1 participants into Phase 2 of CRIC 2. To collect exposure and outcome data per the CRIC Phase 1 and 2 protocols 3. To maintain high levels of retention in the study 4. To investigate self-reported clinical events and obtain supporting medical records and documentation. 5. To enter data and process/ship biological specimens. 6. To implement local quality assurance and quality control procedures as a means to obtain standardized, high quality measurements 7. To monitor data collection, data entry, and follow-up rates 8. To participate in governance and oversight of the CRIC study through studywide subcommittees and activities 9. To publish and present findings from the CRIC Study 10. To promote and support the conduct of ancillary studies in CRIC, including collaboration with the broader nephrology research community. In this application we will outline how our site has fulfilled its obligation in phase 1, how it has contributed in particular to ancillary studies in CRIC.