EVENT RECORDINGS OF HIGH RISK INFANTS ON APNEA MONITORS

这是波士顿大学医学中心（BUMC）的一项提案， 数据协调和分析中心（DCAC） 高危婴儿事件记录的多中心协作研究 呼吸暂停 建议的目标是： 拥有高素质的专业人员， 流行病学、生物统计学和数据管理; 一个组织框架，将这些技能编织在一起， 领导;并建立一个DCAC，在响应和敏感的 研究其他组成部分的需求，这构成了真正的 团队合作的努力。 该提案阐明了几个 研究设计中的困难和关键问题， 特别是那些DCAC可以进行重大合作的项目， 贡献 该提案记录了对以下方面作用的理解： 列出民政事务总署的具体工作 在研究的三个指定阶段中， 详细说明拟议的数据管理中心在数据管理方面的活动。 这些 中心的主要活动包括：合作设计研究， 制定方案、操作手册和数据表格;设计和 实施数据库管理系统和质量保证及质量 控制系统;培训现场人员进行数据收集;协作 随着研究的发展，完善和修改研究程序;提供 在规划附带利益方面的统计和数据管理专门知识， 卫星研究;响应 研究;计划和进行数据分析;合作撰写报告 并介绍研究结果。 该提案记录了 拟议研究小组在以下方面的资格： 和临床研究经验的广度;他们在 随机临床试验的设计、实施和分析， 观察性流行病学研究;他们最近的合作努力 在临床研究中，特别是在母婴方面， 健康;他们作为有效的团队合作者的记录， 多学科研究;以及丰富的学术资源， 在研究过程中，如有需要，团队可以调用部署。

This is a proposal from Boston University Medical Center (BUMC) for the conduct of the Data Coordinating and Analysis Center (DCAC) of the multicenter collaborative study of Event Recordings of High Risk Infants on Apnea Monitors. The goals of the proposal are: to staff the DCAC with highly qualified professionals with skills in neonatology, epidemiology, biostatistics and data management; to provide an organizational framework that weaves together these skills under strong leadership; and to create a DCAC that in responsive and sensitive to the needs of the other components of the study and that constitutes a truly collaborative team effort. The proposal elucidates several of the difficulties and key issues entailed in the design of the study, particularly those in which the DCAC can make a major collaborative contribution. The proposal documents an understanding of the role of the DCAC by outlining lists of specific tasks for the DCAC to undertake in each of the three designated phases of the study, and with an elaboration of the proposed DCAC's activities in data management. These major activities of the DCAC include: collaborate in study design, development of protocol, Manual of operations and data forms; design and implement database management system and quality assurance and quality control systems; train field personnel in data collection; collaborate in refining and modifying study procedures an the study evolves; provide statistical and data management expertise in planning spinoff and satellite studies; respond to data requests from various components of the study; plan and conduct data analyses; collaborate in report writing and presention of study results. The proposal documents the qualifications of the proposed research team in regard to: their depth and breadth of clinical research experience; their achievements in the design, conduct and analysis of randomized clinical trials and observational epidemiologic studies; their recent collaborative efforts in clinical research, particularly in regard to maternal and child health; their track records as effective team players in collaborative, multidisciplinary research; and the rich academic resources that the team can call upon to deploy if needed during the course of the study.