KIDNEY DISEASE/HYPERTENSION IN AFRICAN AMERICANS--DCC

非洲裔美国人研究数据协调中心(DCC) 肾脏疾病和高血压(AASK)全面试验将协调 研究的科学性和可操作性。这项研究将 检测三种阶梯式护理方案的降血效果 非裔美国人的血压和两种血压控制水平 合并高血压肾病以延缓肾功能丧失 功能以肾小球滤过率衡量。 在招聘阶段(第一阶段)的过渡期内，发展合作委员会将 与指导一起审查试点研究数据和方案 委员会最终敲定了全面试验的设计。数据系统 采集(通过分布式数据输入)和数据管理(使用 甲骨文)将被建立。DCC的一项主要活动将是 制定数据质量控制程序。回顾 将完成《业务手册》和数据表格的定稿工作。 将生成入院患者的随机时间表。 克利夫兰诊所的中央设施将为 一种药物对肾功能和生化指标的检测 协调抗高血压药物配送的配送中心 药物。DCC将对临床中心进行集中培训 学习科目的录入、学习表格的填写、 使用分布式数据录入系统和肾功能测试。 协调委员会将安排指导委员会的会议，并参与 这些会议并报告会议记录。 在第一阶段开发的数据库管理系统将用于确保 准确、完整地收集研究数据。一个查询系统将是 用于解决数据差异。DCC的一个主要职能是 招募阶段(第一阶段)的研究将是监测患者 招募和合规性作为整体和临床中心。学习 进展情况将以每月报告的形式报告给临床中心， 时事通讯、指导委员会的演示文稿以及数据和 安全监督委员会会议。将进行统计分析 在完成并报告最终分析的研究过程中 在研究的第三阶段。DCC将开发新的统计数据 适当分析所收集的数据所需的方法。 由于这项研究是一项多中心的努力，包括几个 作为组织组成部分，DCC将积极主动地履行其职责 职责，以实现研究的目标。DCC将致力于促进 合作精神，这在这个多中心的研究中很重要。

The Data Coordinating Center (DCC) for the African American Study of Kidney Disease and Hypertension (AASK) Full-Scale Trial will coordinate the scientific and operational aspects of the Study. This Study will examine the effectiveness of three stepped-care regimens in lowering blood pressure and two levels of blood pressure control in African Americans with hypertensive renal disease in order to slow the loss of kidney function as measured by glomerular filtration rate. In the transition months of the Recruitment Phase (Phase I), the DCC will review the Pilot Study data and protocol in conjunction with the Steering Committee to finalize the design of the Full-Scale Trial. Systems for data acquisition (via distributed data entry) and data management (using Oracle) will be established. A major activity of the DCC will be the development of procedures for control of the quality of the data. Review and finalization of the Manual of Operations and data forms will be done. The randomization schedule for entering patients will be generated. Central facilities at the Cleveland Clinic will be established for the measurement of renal function and biochemistry along with a Drug Distribution Center to coordinate the distribution of antihypertensive medications. The DCC will provide centralized training of Clinical Center staff in the areas of entry of study subjects, completion of study forms, use of the distributed data entry system and testing of renal function. The DCC will arrange meetings of the Steering Committee and participate in these meetings and report the proceedings. The database management system developed in Phase I will be used to assure accurate and complete collection of study data. A query system will be used to resolve data discrepancies. A major function of the DCC during the Recruitment Phase (Phase I) of the study will be to monitor patient recruitment and compliance as a whole and by Clinical Center. Study progress will be reported in monthly reports to the Clinical Centers, newsletters, and presentations at the Steering Committee, and Data and Safety Monitoring Board meetings. Statistical analyses will be performed during the course of the study with final analyses completed and reported during Phase III of the study. The DCC will develop new statistical methodology as needed to properly analyze the data being collected. Since the Study is a multi-centered effort including several organizational components, the DCC will be proactive in performing its duties so that the goals of the study are met. The DCC will work to foster a spirit of cooperation which is important in this multi-center study.