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学中心（CCEB）申请继续担任NIMH非裔美国人夫妇（AAC）研究多中心HIV/STD预防试验的数据协调中心（DCC）。最初，有限的DCC活动是在美国的R 01中资助的。但是为了支持扩展的U 01级别的多站点协调，发展到扩展的角色，并且现在正在单独的DCC应用中提出。拟议的DCC将继续为四个研究中心（哥伦比亚大学、埃默里大学、加州大学、洛杉矶和宾夕法尼亚大学）的随机对照试验（RCT）提供行政和项目管理、生物统计、数据管理和研究计算领导。此外，DCC将继续作为总体基础设施，以促进四个研究中心的共同方案管理和数据收集程序。拟议的发展协调委员会具有独特的地位，具有基于经验的科学、技术和行政领导能力，可以协调审计咨询委员会的这一项目，因为它自2002年获得原始赠款以来一直在这样做。为了继续支持这项多中心RCT，DCC将提供必要的技术专业知识，以实施和支持数据收集、质量保证（QA），并通过在研究中心现有硬件上部署的安全数据管理系统（DMS）进行报告，包括带有音频和视频指导的新型自动计算机辅助自我访谈（ACASI）系统。该DMS将支持（在每个研究中心）夫妇筛选和入组、数据收集和夫妇跟踪以及数据传输至DCC。此外，发展协调委员会将继续支持用于输入纸质病例报告表中记录的数据的数据管理系统，并将其转交给发展协调委员会。DCC将执行数据安全和访问、QA、存储、备份、灾难恢复程序，并将提供定期监测和QA报告（例如，季度）。DCC将通过组织指导委员会会议、协调RCT材料的开发和分发、向NIMH项目办公室和数据与安全性监查委员会（DSMB）提供中期数据总结以及侧重于RCT实施和质量保证的监查报告，提供科学设计和分析、后勤和行政支持。此外，DCC将提供中期和最终统计分析，以及所有科学出版物的合作。

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.