WIHS Data Management and Analysis Center (WDMAC)

描述(由申请人提供)：妇女机构间艾滋病毒研究(WIHS)是一项大型、全面的前瞻性队列研究，旨在调查与高效抗逆转录病毒治疗时代妇女艾滋病毒感染的发病机制和自然病史有关的一系列问题。这一应用程序的目的是扩大对WIHS数据管理和分析中心(WDMAC)的支持，WDMAC将继续领导为WIHS研究议程贡献流行病学和统计专业知识，提供稳定和高效的数据管理系统，并协调研究方案和WIHS调查员倡议，以提高WIHS数据和科学研究的质量和有效性。WDMAC的具体目标是：(1)在临床研究议程中提供科学领导，重点是分析方法、利用建模和创新的随机行为干预试验改善抗逆转录病毒治疗依从性的战略，以及对艾滋病毒临床流行病学的深入队列描述；(2)通过合作和科学伙伴关系，优化WIHS对了解妇女艾滋病毒感染的发病机制和自然和治疗历史的贡献；(3)通过促进WIHS与外部研究人员、工作组和委员会之间的沟通，协调研究倡议和科学陈述；协调研究方案并形成修订；并编制全研究范围的队列特征简介(WIHS档案)和科学出版物(WIHS档案)；(4)维护和完善我们的网络数据管理系统，评估可行性，协调从纸质数据收集的过渡。我们将继续我们的系统：跟踪生物标本在国家储存库的存储和转移，制作年度公共数据集，并开展培训，以促进研究数据的适当使用，用于当地研究；(5)继续与临床站点合作开展质量保证计划，整合数据管理、研究协调、统计方法和科学学科方面的专业知识。该计划将继续监测整个研究的质量，并促进标准化数据收集的遵守和培训。

DESCRIPTION (provided by applicant): The Women's Interagency HIV Study (WIHS) is a large, comprehensive prospective cohort study designed to investigate a spectrum of questions relating to the pathogenesis and natural history of HIV infection among women in the era of highly active antiretroviral therapy. The purpose of this application is to extend support of the WIHS Data Management and Analysis Center (WDMAC) that will continue to provide leadership in contributing epidemiological and statistical expertise to the WIHS research agenda, provide a stable and efficient data management system, and provide coordination of study protocols and WIHS investigator initiatives to enhance the quality and validity of the data and the scientific research in the WIHS. The specific aims of WDMAC are: (1) To provide scientific leadership in a Clinical Research Agenda focusing on analytical methods, strategies for improving antiretroviral therapy adherence using both modeling and an innovative randomized behavioral intervention trial, and in-depth cohort profiles of the clinical epidemiology of HIV; (2) To optimize the contributions of the WIHS to the understanding of the pathogenesis and natural and treated history of HIV infection in women through collaboration and scientific partnerships; (3) To coordinate research initiatives and scientific presentations by facilitating communication among WIHS and external investigators, Working Groups and committees; to orchestrate study protocol and form revision; and produce study-wide profiles of cohort characteristics (WIHS Dossier), and scientific publications (WIHS Archives); (4) To maintain and refine our web-based data management system and assess feasibility and coordinate the transition from paper-based data collection. We will continue our systems for: tracking the storage and transfer of biological specimens at national repositories, producing annual public data sets, and conducting training in methods that facilitates the appropriate use of study data for local research; (5) To continue our quality assurance program in partnership with the clinical sites that integrates expertise in data management, study coordination, statistical methodology, and scientific disciplines. This program will continue to monitor study-wide quality and promote adherence and training for standardized data collection.