WIHS Data Management and Analysis Center(WDMAC)

描述：妇女跨机构艾滋病毒研究（WIHS）是一项大型、全面的队列研究，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。此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，该中心将继续提供“为WIHS研究议程提供流行病学和统计专业知识，提供稳定有效的数据管理系统，并提供研究方案和WIHS研究者倡议的协调，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WIHS研究数据的设计、分析和呈现方面发挥领导作用，并开发适用于WIHS科学研究活动的新颖统计和流行病学方法。这一目标的一个核心组成部分将是区分与正常衰老过程相关的因素与艾滋病毒感染和抗病毒治疗的使用；(2)建立、实施和维护数据管理系统，包括数据录入、传输、文件编制、编辑、存储和汇总。这一目标的组成部分将是建立一个系统，跟踪在国家储存库储存和转移生物标本，并每年制作公共数据磁带；(3)建立和实施协调研究计划和科学报告的方法，促进WIHS调查人员、工作组和委员会之间的沟通，协调研究方案和表格的修订，并制作研究范围内的队列特征概况（WIHS档案）、研究数据库和正在进行的研究计划（WDMAC报告）和科学出版物（WIHS档案）；(4)实施质量保证计划，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。该项目将促进对标准化数据收集和管理项目的遵守和培训。一项关键的科学倡议将建立在我们现有经验的基础上，以开发观察性研究中治疗效果的适当评估方法。

DESCRIPTION: The Women's Interagency HIV Study (WIHS) is a large, comprehensive 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) which 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 leadership in the design, analysis, and presentation of WIHS study data and to develop novel statistical and epidemiologic methodology applicable to the scientific research initiatives of the WIHS. A core component of this aim will be to distinguish factors associated with the normal aging process from HIV infection and the use of anti-viral therapies; (2) To establish, implement, and maintain a data management system encompassing data entry, transmission, documentation, editing, storage, and summarization. Components of this aim will be to establish a system for tracking the storage and transfer of biological specimens at the national repository, and produce annual public data tapes; (3) To establish and implement methods to coordinate research initiatives and scientific presentations, to facilitate communication among WIHS investigators, Working Groups, and Committees, to orchestrate revisions of study protocols and forms, and to produce study-wide profiles of cohort characteristics (WIHS Dossier), the study database and ongoing research initiatives (WDMAC Report), and scientific publications (WIHS Archives); (4) To implement a quality assurance program that integrates expertise in data management, study coordination, statistical methodology, and scientific disciplines. This program will promote adherence and training for standardized data collection and management programs. A key scientific initiative will build upon our existing experience to develop methods for the appropriate evaluation of the effects of therapies in observational studies.