Prospective renal insufficiency cohort evaluation: PRICE

描述(申请人提供)：2002-2012年间，NIDDK赞助的前瞻性慢性肾功能不全队列(CRIC)研究在7个临床中心招募了3939名患有慢性肾脏病(CKD)的成年人，以解决总体目标，即确定CKD进展的危险因素，并澄清肾功能障碍与亚临床和临床心血管事件、死亡和资源利用的风险之间的关系。 审评委的最初10年后续行动--第一阶段。审评委第二阶段，将后续行动延长至2013年4月30日。本申请是代表宾夕法尼亚大学(宾夕法尼亚大学)临床中心根据RFA-DK-12-508“有限竞争：慢性肾功能不全队列(CRIC)研究的延续(U01)”提交的。在审评委的第一和第二阶段，宾夕法尼亚州立大学是一个模范网站，超过了其招聘目标，实现了高的后续行动率和出色的数据质量，并为全研究范围的治理和实施作出了积极贡献。在第三阶段，宾夕法尼亚大学临床中心有以下具体目标：1.重新招收较高比例的CRIC第一阶段参与者进入CRIC 2的第三阶段。再招收214名参与者参加CRIC第三阶段。根据CRIC第三阶段方案收集暴露和结果数据。4.在研究中保持高水平的保留率5.调查自我 报告临床事件，并获得支持的医疗记录和文件。6.输入数据和处理/运送生物标本。7.执行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8.监测数据收集、数据输入和随访率9.参与治理 通过研究范围的小组委员会和活动对审评委进行监督和监督10.发表和介绍审评委研究的结果11.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。我们期待着有机会继续参与这项独特而重要的研究。

DESCRIPTION (provided by applicant): Between 2002-2012, the NIDDK-sponsored prospective Chronic Renal Insufficiency Cohort (CRIC) Study enrolled 3939 adults with chronic kidney disease (CKD) at 7 Clinical Centers to address overarching goals of identifying risk factors for CKD progression and clarifying the relationship between kidney dysfunction and the risks of subclinical and clinical cardiovascular events, death, and resource utilization through an initial 10-year follow-up of CRIC-Phase 1. Phase 2 of CRIC, extended follow-up through April 30, 2013. This application is submitted in response to RFA-DK-12-508, "Limited Competition: Continuation of the Chronic Renal Insufficiency Cohort (CRIC) Study (U01)," on behalf of the University of Pennsylvania (Penn) Clinical Center. In Phases 1 and 2 of CRIC, the Penn was a model site that exceeded its recruitment goal, achieved high follow-up rates and outstanding data quality, and that contributed actively to study-wide governance and implementation. In Phase 3, the Penn clinical center has the following specific aims: 1. To re-enroll a high percentage of CRIC Phase 1 participants into Phase 3 of CRIC 2. To enroll an additional 214 participants into Phase 3 of CRIC 3. To collect exposure and outcome data per the CRIC Phase 3 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 9. To participate in governance and oversight of CRIC through study wide subcommittees and activities 10. To publish and present findings from the CRIC Study 11. To promote and support the conduct of ancillary studies in CRIC, including collaboration with the broader nephrology research community. We look forward to the opportunity to continue participation in this unique and important study.