WIHS Data Management and Analysis Center (WDMAC)

描述（由申请人提供）：妇女跨机构艾滋病毒研究（WIHS）是一项大型、全面的前瞻性队列研究，旨在调查在高活性抗逆转录病毒治疗时代妇女中与艾滋病毒感染的发病机制和自然史有关的一系列问题。本应用程序的目的是扩展对WIHS数据管理和分析中心（WDMAC）的支持，该中心将继续在为WIHS研究议程贡献流行病学和统计专业知识方面发挥领导作用，提供稳定有效的数据管理系统，并协调研究方案和WIHS研究者的倡议，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，重点关注分析方法，利用模型和创新的随机行为干预试验提高抗逆转录病毒治疗依从性的策略，以及深入的艾滋病毒临床流行病学队列概况；(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、自然史和治疗史的贡献；(3)通过促进卫生系统与外部调查人员、工作组和委员会之间的沟通，协调研究倡议和科学报告；协调研究方案和表格修订；并制作研究范围内的队列特征概况（WIHS档案）和科学出版物（WIHS档案）；(4)维护和完善基于网络的数据管理系统，评估可行性并协调从纸质数据收集的过渡。我们将继续我们的系统：跟踪国家储存库中生物标本的储存和转移，制作年度公共数据集，并开展促进适当使用研究数据进行当地研究的方法培训；(5)继续我们的质量保证计划，与临床站点合作，整合数据管理、研究协调、统计方法学和科学学科方面的专业知识。该项目将继续监测整个研究的质量，并促进对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.