Prevention of Adult Caries Study (PACS) Data Coordinating Center

数据协调中心将支持预防成人龋齿研究(PACS)的活动。 PAC的主要目的是：1)测试洗必泰(10%w/v)牙科涂层与 安慰剂涂层，减少高危成年人的成人龋齿增加，以及2)评估成本和成本- 洗必泰(10%w/v)涂层在四种牙科护理输送系统中的使用效果。 数据协调中心将提供行政、后勤和生物统计支持 PACS协议的开发、实施和成功完成。要做到这一点 目标，DCC将：1)开发安全的研究专用Web门户，作为以下方面的主要资源 研究范围内的沟通、数据录入、文档编制和监控；2)安排和进行持续 对研究人员进行数据收集、数据录入和试验监测方面的培训和认证； 3)监测诊所的招聘和数据采集和数据录入的及时性，并执行质量 所有研究数据的保证(QA)程序；4)建立生成和分配协议 研究处理的随机化分配和适当标签；5)跟踪收集、转移和 对微生物标本进行实验室分析并对结果数据进行统计分析；6)进行 每年进行实地视察，监察诊所和化验室遵守良好临床实务指引的情况； 7)协调整体学习活动，包括安排会议和电话会议、记录和 分发会议记录并准备研究材料(例如，患者资格快速参考卡、患者 资料手册)；8)向数据和安全监测委员会提供后勤支助，包括 安排会议和电话会议，记录和分发会议记录，并报销费用 和酬金；9)在国家一级积极参与审判委员会；10)提供统计数据 为研究调查人员提供咨询和分析支持，包括制定和执行 全面的研究数据分析计划，为FDA新药准备支持文件 申请和支持研究批准的论文的准备；11)开发和维护一个系统，以 确定牙科护理的利用和评估，并为每个临床研究人员提供支持 建立使用率和成本数据收集和质量控制程序中心；12)开发系统 为及时分析研究数据和编写和制作手稿提供便利； 13)准备并监督最终研究数据的分发；以及14)准备公共网页以 提供有关PACS的信息(非专业术语)，并发布研究结果摘要。

The Data Coordinating Center will support the activities of the Prevention of Adult Caries Study (PACS). PACS primary aims are 1) to test the hypothesis that chlorhexidine (10% w/v)dental coating, compared to a placebo coating, reduces adult caries increment in at-risk adults, and 2) to evaluate the cost and cost- effectiveness of using the chlorhexidine (10% w/v) coating in four dental care delivery systems. The Data Coordinating Center will provide administrative, logistical, and biostatistical support for the development, implementation, and successful completion of the PACS protocol. To accomplish this objective, the DCC will: 1) develop a secure study-specificWeb portal to serve as a primary resource for study-wide communication, data entry, documentation, and monitoring; 2) arrange for and conduct ongoing training and certification of study staff with respect to data collection, data entry, and trial monitoring; 3) monitor recruitment and timeliness of data acquisition and data entry at the clinics and carry out quality assurance (QA) procedures on all study data; 4) establish a protocol for generating and allocating randomization assignments and appropriate labeling of study treatments; 5) track the collection, transfer, and laboratory analysis of microbiology specimens and conduct statistical analysis of the results data; 6) conduct yearly site visits to monitor clinic and laboratory compliance with Good Clinical Practice guidelines; 7) coordinate overall study activities, including scheduling meetings and conferencecalls, recording and distributing minutes, and preparing study materials (e.g., patient eligibility quick reference cards, patient information brochures); 8) provide logistical support to the Data and Safety Monitoring Board, including scheduling meetings and conferencecalls, recording and distributing minutes, and reimbursing for expenses and honoraria; 9) actively participate at the national level on trial-wide committees; 10) provide statistical consultation and analytic support to study investigators, including formulating and executing a comprehensive plan for analysis of study data, preparing supporting documentation for an FDA new drug application, and supporting preparation of study-approved papers; 11) develop and maintain a system to identify dental care utilization and valuations, and provide support to study investigators at each clinical center to establish utilization and cost data collection and quality control procedures; 12) develop systems that facilitate the timely analysis of study data and the preparation and production of manuscripts; 13) prepare and overseedistribution of the final ("locked") study data; and 14) prepare a public Web page to provide information (in lay terms) regarding PACS and to post synopses of study findings.