Limited Competition: Chronic Renal Insufficiency Cohort (CRIC) Study

描述(由申请人提供)： 在2002-2006年间，前瞻性慢性肾功能不全队列(CRIC)研究招募了3612名患有慢性肾脏疾病的成年人，以解决总体目标，以确定肾脏疾病快速进展的预测因素，并通过最初5年的随访评估肾功能障碍与亚临床和临床心血管事件、死亡和资源利用的风险之间的关系。拟议的审评委第二阶段将后续行动延长至2013年，提供了一个独特的机会，可以利用审评委现有的努力和成功，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。 凯斯西部储备大学临床中心要解决的具体目标是： 1.重新招收高比例的审评委第一阶段参与者进入审评委第二阶段 2.按照审评委第一阶段和第二阶段议定书收集暴露和结果数据 3.在研究中保持较高的留存水平 4.调查自己报告的临床事件，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，以此作为获得标准化、高质量测量的手段 7.监测数据收集、数据录入和随访率 8.通过全研究范围的小组委员会和活动参与对审评委研究报告的管理和监督 9.发表和提出审评委研究结果 10.促进和支持在审评委开展辅助研究，包括与更广泛的肾病学研究界合作。

DESCRIPTION (provided by applicant): Between 2002-2006, the prospective Chronic Renal Insufficiency Cohort (CRIC) Study enrolled 3612 adults with chronic kidney disease to address overarching goals to identify predictors of rapid progression of kidney disease and evaluate 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 Phase 2 of CRIC, which extends follow-up through 2013, offers a unique opportunity to leverage the existing effort and success of CRIC 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 Case Western Reserve University 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.