Data Analysis and Coordination Center for the MACS-WIHS Combined Cohort Study

摘要 多中心艾滋病队列研究 (MACS) 和妇女机构间艾滋病毒研究 (WIHS) 相结合 队列研究 (CCS) 是一项大型、全面、前瞻性队列研究，旨在调查一系列 与美国艾滋病毒感染的基础科学、临床科学和流行病学相关的问题， 重点关注男性和女性艾滋病毒感染者的合并症。该应用程序的目的是支持 CCS 数据分析和协调中心 (DACC)。 DACC 的具体目标是： 1) 优化 MACS 和 WIHS 对 通过提供以下信息，了解美国成年人艾滋病毒感染的发病机制和治疗史 流行病学和统计专业知识，并发起和维持成功的科学伙伴关系，以 支持统一的科学议程； 2) 协调招募 2,500 名新 MACS/WIHS-CCS 参与者，包括协调所有临床标准化基线访视的管理 研究地点以及新招募人员的数据与现有综合数据库的整合； 3）协调 研究计划和科学报告；促进CCS与外部的沟通 调查员、工作组和委员会；协调研究方案和表格修订；协调 临床事件的结果确定和裁决；并传播重要的科学发现； 4) 至 开发和维护基于网络的数据管理系统，以协调和集成来自 MACS 的数据 和 WIHS，以及管理根据 CCS 协议收集的新数据。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，产生年度公共数据 并进行培训，以促进适当使用研究数据进行当地研究；和 5) 继续与临床研究中心合作实施我们的质量保证计划，该计划整合了 数据管理、研究协调、统计方法和科学学科方面的专业知识。

ABSTRACT The Multicenter AIDS Cohort Study (MACS) and the Women's Interagency HIV Study (WIHS) Combined Cohort Study (CCS) is a large, comprehensive, prospective cohort study designed to investigate a spectrum of questions relating to the basic science, clinical science, and epidemiology of HIV infection in the US, with a focus on comorbidities among men and women living with HIV. The purpose of this application is to support the Data Analysis and Coordination Center (DACC) for the CCS. The specific aims of the DACC are: 1) To optimize the contributions of the MACS and the WIHS to the understanding of the pathogenesis and treated history of HIV infection in U.S. adults by providing epidemiological and statistical expertise, and initiating and sustaining successful scientific partnerships, to support the unified science agenda; 2) To coordinate the recruitment of 2,500 new MACS/WIHS-CCS participants, including coordination of the administration of standardized baseline visits across all clinical research sites and integration of data from new recruits with the existing combined database; 3) To coordinate research initiatives and scientific presentations; to facilitate communication amongst CCS and external investigators, Working Groups and committees; to orchestrate study protocol and form revision; to coordinate outcome ascertainment and adjudication of clinical events; and to disseminate key scientific findings; 4) To develop and maintain a web-based data management system to harmonize and integrate data from the MACS and WIHS, as well as manage new data collected per the CCS protocol. 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 facilitate the appropriate use of study data for local research; and 5) To continue our quality assurance program in partnership with the clinical research sites that integrates expertise in data management, study coordination, statistical methodology, and scientific disciplines.