DCC-African American Couples

描述(由申请人提供)：这是宾夕法尼亚大学医学中心临床流行病学和生物统计中心(CCEB)继续担任NIMH非裔美国夫妇艾滋病毒/性传播疾病预防多点试验(AAC)研究的数据协调中心(DCC)的申请。最初，有限的DCC活动是在宾夕法尼亚大学的R01中提供资金的，但为了支持扩展的U01多站点协调级别，进展到更大的作用，现在建议在单独的DCC应用程序中进行。拟议的DCC将继续在哥伦比亚大学、埃默里大学、加州大学洛杉矶分校和宾夕法尼亚大学这四个研究地点为这项随机对照试验(RCT)提供行政和项目管理、生物统计学、数据管理和研究计算领导。此外，数据协调中心将继续作为最重要的基础设施，促进四个研究地点的共同礼宾管理和数据收集程序。拟议的DCC具有独特的地位，拥有基于经验的科学、技术和行政领导，以协调这个AAC项目，自2002年最初的赠款获得资助以来，它一直在这样做。为继续支持这一多站点随机对照研究，数据协调中心将提供必要的技术专长，通过部署在站点的现有硬件上的安全数据管理系统(DMS)实施和支持数据收集、质量保证(QA)和报告，包括具有音频和视觉指导的新型自动计算机辅助自访(ACASI)系统。该DMS将(在每个站点)支持夫妇筛选和登记、数据收集、夫妇跟踪以及向DCC传输数据。此外，疾病预防控制中心将继续支持用于输入纸质案件报告表上记录的数据的数据管理系统，并将这些数据转发给预防犯罪控制委员会。DCC将执行有关数据安全和访问、质量保证、存储、备份、灾难恢复的程序，并将提供定期监测和质量保证报告(例如，季度报告)。DCC将提供科学设计和分析、后勤和行政支持，方法是组织指导委员会会议，协调RCT材料的开发和分发，并向NIMH计划办公室和数据和安全监测委员会(DSMB)提供中期数据摘要和监测报告，重点是RCT的实施和质量保证。此外，DCC将提供临时和最终统计分析，并就所有科学出版物进行合作。

DESCRIPTION (provided by applicant): This is an application from the Center for Clinical Epidemiology and Biostatistics (CCEB) at the University of Pennsylvania Medical Center to continue serving as the Data Coordinating Center (DCC) for the NIMH MultiSite HIV/STD Prevention Trial for African American Couples (AAC) Study. Originally, limited DCC activities were funded within the R01 at the U. of Pennsylvania, but in order to support the expanded U01 level of multisite coordination, progressed to an expanded role, and are now being proposed within a separate DCC application. The proposed DCC will continue providing administrative and project management, biostatistical, data management and research computing leadership for this randomized controlled trial (RCT) across each of four study sites; Columbia University, Emory University, University of California, Los Angeles and the University of Pennsylvania. Additionally, the DCC will continue to serve as the overarching infrastructure to facilitate common protocol administration and data collection procedures across the four study sites. The proposed DCC is uniquely positioned with experience-based scientific, technical and administrative leadership to coordinate this AAC project, as it has been doing since the original grant was funded in 2002. To continue supporting this multisite RCT, the DCC will provide technical expertise necessary to implement and support data collection, quality assurance (QA), and reporting via a secure data management system (DMS) deployed at the sites on existing hardware, including a novel Automated Computer Assisted Self Interview (ACASI) system with audio and visual guidance. This DMS will support (at each site) couple screening and enrollment, data collection, and tracking of couples and data transfer to the DCC. In addition, the DCC will continue to support the DMS used to enter data recorded on paper case report forms, forwarded to the DCC. The DCC will execute procedures for data security and access, QA, storage, back-up, disaster recovery, and will provide periodic monitoring and QA reports (e.g., quarterly). The DCC will provide the scientific design and analysis, logistical and administrative support by organizing meetings of Steering Committees, coordinating development and distribution of RCT materials, and providing the NIMH Program Office, and the Data and Safety Monitoring Board (DSMB) with interim data summaries, and monitoring reports focused on the conduct and quality assurance of the RCT. Further, the DCC will provide interim and final statistical analyses, as well as collaboration on all scientific publications.