PEDIATRIC AIDS CTG--STATISTICAL/DATA MANAGEMENT CENTER

本申请是一项建议，以作为统计和数据 儿科艾滋病临床试验组管理中心， 与由斯蒂芬博士领导的PACTG中央小组建立联系 斯派克特。我们的总体目标和宗旨是对所有人负责 特设工作组的统计和数据管理活动，包括：(1) 在PACTG的设计和分析方面提供统计领导 研究；(2)建立和管理中央数据管理 系统；(3)与PACTG调查人员就科学和技术问题开展合作 程序性问题和长远规划，(4)进行次要和 交叉研究数据库分析，以及(5)进行统计研究 关于PACTG使命的核心问题。 国家药品监督管理委员会对PACTG小组主席和儿科委员会负责 执行委员会。确保完成我们的职责 及时生产高质量的产品，我们有(1) 建立统计和数据管理中心，每个中心由一个 明确的管理、行政和组织结构， 并行并促进与PACTG协议团队和 委员会；以及(2)组建了一支高素质和经验丰富的工作人员队伍 临床试验专家。

This application is a proposal to serve as the Statistical and Data Management Center of the Pediatric AIDS Clinical Trials Group (PACTG), in affiliation with the PACTG Central Group headed by Dr. Stephen Spector. Our overall objectives and aims are to be responsible for all statistical and data management activities of the PACTG, including: (1) providing statistical leadership in the design and analysis of PACTG studies; (2) establishing and administering a central data management system; (3) collaborating with PACTG investigators on scientific and procedural issues and long-range planning, (4) conducting secondary and cross-study database analyses, and (5) conducting statistical research on issues central to the PACTG's mission. The SDMC is accountable to the PACTG Group Chair and the Pediatric Executive Committee. To ensure that our responsibilities are completed in a timely manner and yield products of high quality, we have (1) established statistical and data management centers, each governed by a well-defined management, administrative and organizational structure that parallels and facilitates interactions with the PACTG protocol teams and committees; and (2) assembled a staff of highly-qualified and experienced clinical trial specialists.