Prevention of Adult Caries Study (PACS) Data Coordinating Center

描述（由申请人提供）：数据协调中心将支持成人龋齿预防研究（PACS）的活动。PACS的主要目的是：1）检验以下假设：与安慰剂涂层相比，氯己定（10%w/v）牙科涂层可减少高危成人的成人龋齿增量; 2）评价在四种牙科护理递送系统中使用氯己定（10%w/v）涂层的成本和成本效益。数据协调中心将为PACS方案的开发、实施和成功完成提供行政、后勤和生物统计支持。为实现这一目标，DCC将：1）开发一个安全的研究特定门户网站，作为研究范围内沟通、数据输入、文件记录和监查的主要资源; 2）安排并持续对研究工作人员进行数据收集、数据输入和试验监查方面的培训和认证; 3）监测招募和数据采集的及时性以及诊所的数据输入，并对所有研究数据进行质量保证（QA）程序; 4）建立用于生成和分配随机分配以及研究治疗的适当标签的方案; 5）跟踪微生物标本的采集、转移和实验室分析，并对结果数据进行统计分析; 6）每年进行现场访问，以监测诊所和实验室是否符合药物临床试验质量管理规范指南; 7）协调整体研究活动，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，患者信息手册）; 8）为数据和安全性监测委员会提供后勤支持，包括安排会议和电话会议，记录和分发会议记录，以及报销费用和酬金; 9）积极参与国家一级的试验委员会; 10）为研究者提供统计咨询和分析支持，包括制定和执行全面的研究数据分析计划，为FDA新药申请准备支持文件，和支持研究批准文件的准备; 11）开发和维护一个系统，以识别牙科护理利用和评估，并为每个临床中心的研究研究者提供支持，以建立利用和成本数据收集和质量控制程序; 12）开发系统，以促进研究数据的及时分析和手稿的准备和制作; 13）准备和监督最终（“锁定”）研究数据的分发;以及14）准备一个公共网页，以提供有关PACS的信息（以非专业术语）并发布研究结果的概要。

DESCRIPTION (provided by applicant): 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-specific Web 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 conference calls, 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 conference calls, 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 oversee distribution 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.