Limited Competition for the Continuation of the Chronic Renal Insufficiency Cohor

描述(申请人提供)：2003年至20013年间，前瞻性慢性肾功能不全队列研究招募了3,939名患有慢性肾脏疾病的成年人，以解决主要目标，即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、死亡的风险之间的关系。审评委第三阶段将后续行动延长至2018年，并招募了新的参与者群体，这为利用现有努力提供了独特的机会 CRIC成功地建立了一组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局进行了长期的前瞻性跟踪。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。凯斯西储大学临床中心要解决的具体目标是：1.重新招收高比例的现有CRIC参与者进入CRIC 2第三阶段。招募215名符合研究方案定义的资格标准的新参与者。3.根据CRIC方案收集暴露和结果数据。4.在研究中保持较高的保留率，5.调查自我报告的临床事件并获得支持的医疗记录和文件，6.输入数据并处理/运送生物标本。7.实施当地质量保证和质量控制程序，作为获得标准化、高质量测量的手段8.监测数据收集、数据录入和随访率8.通过积极参与研究范围内的小组委员会和活动，参与对审评委研究的全面管理和监督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 2003-20013, the prospective Chronic Renal Insufficiency Cohort (CRIC) Study enrolled 3939 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. The third phase of CRIC extending follow-up through 2018, and recruiting a new cohort of participants 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 current CRIC participants into Phase 3 of CRIC 2. To recruit 215 new participants meeting eligibility criteria defined by the study protocol 3. To collet exposure and outcome data per the CRIC protocol 4. To maintain high levels of retention in the study, 5. To investigate self-reported clinical events and obtain supporting medical records and documentation, 6. To enter data and process/ship biological specimens. 7. To implement local quality assurance and quality control procedures as a means to obtain standardized, high quality measurements 8. To monitor data collection, data entry, and follow-up rates 8. To participate in the overall governance and oversight of the CRIC study through active involvement in study wide 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.