Stillbirth Network

RTI国际（RTI），三角研究所的商标名称，建议成为数据 协调和分析中心（DCAC）为NICHD的“研究范围和死产的原因， 美国“网络。RTrs拥有29年担任DCAC的经验，为众多多站点提供服务 临床和行为研究，许多是在孕产妇和儿童健康领域，使我们认识到， 民政事务总署必须承担的各种责任，以成功地满足不断变化的需求， 多中心研究。这些职责包括但不限于：（1）参与方案 开发，（2）开发和实施研究范围内的通信网络，（3）提供 先进的数据收集和管理系统，以应对新出现的需求， 研究，（4）根据需要支持研究的后勤工作，（5）协助培训研究中心工作人员， 研究程序，（6）协助制定和实施质量控制和质量保证 程序，（7）提供生物统计和数据管理领导，（8）制作常规和广告 满足临床研究中心、NICHD、指导委员会、咨询委员会 委员会和数据安全和监测委员会，以及（9）帮助传播 通过出版物和演讲进行研究。该项目的主要工作人员，Corette帕克博士，PI， 马修·科赫博士，共同PI，都是高级生物统计学家，支持流行病学项目。 他们每人都拥有超过15年的管理DCAC活动和领导多地点统计任务的经验 问题研究科赫博士的医学学位提供了一个额外的徽章之间的统计和医学 网络的组成部分。随着网络需求的变化，我们将能够补充我们的基础 从我们庞大的工作人员中挑选出具有所需专业知识的工作人员，这些工作人员的背景都很复杂，可以满足预期的需求 的研究。RTI的办公室隔壁NICHD在罗克维尔，MD提供会议空间， 与NICHD工作人员互动。 在项目的第一年，RTI将与NICHD和指导委员会合作， 制定研究方案，特别是统计设计和分析，数据采集方法， 数据管理和处理、质量控制以及现场数据收集和数据管理的培训 工作人员

RTI International (RTI), a trade name for Research Triangle Institute, proposes to become the Data Coordinating and Analysis Center (DCAC) for NICHD's "Research on the Scope and Causes of Stillbirth in the United States" network. RTrs twenty-nine years of experience serving as DCAC for a vadety of multisite clinical and behavioral studies, many in the field of maternal and child health, enable us to recognize the various responsibilities that must be undertaken by a DCAC to successfully meet the ever changing needs of a multisite study. These responsibilities include, but are not limited to: (1) participating in protocol development, (2) developing and implementing a study-wide communications network, (3) providing sophisticated data collection and management systems that are responsive to the emerging needs of the study, (4) supporting the logistics of the study as needed, (5) assisting in training site personnel in standard study procedures, (6) assisting in developing and implementing quality control and quality assurance procedures, (7) providing biostatistical and data management leadership, (8) producing both routine and ad hoc reports that meet the needs of the Clinical Sites, NICHD, the Steering Committee, the Advisory Committee and the Data Safety and Monitoring Committee, and (9) helping to disseminate the results of the study through publications and presentations. The key staff proposed for the project, Dr. Corette Parker, PI, and Dr. Matthew Koch, Co-PI, are both senior biostatisticians with supporting programs in epidemiology. They each have over 15 years experience managing DCAC activities and leading statistical tasks for multisite studies. Dr. Koch's medical degree provides an additional badge between the statistical and medical components of the network. As the demands of the network change, we will be able to supplement our base staff with needed expertise from our large staff with vaded backgrounds that address the anticipated needs of the study. RTI' office next door to NICHD in Rockville, MD provides meeting space as needed for interaction with NICHD staff. During the first year of the project, RTI will collaborate with NICHD and the Steering Committee to develop the study protocol with particular input into statistical design and analysis, data capture methods, data management and processing, quality control, and training of site data collection and data management staff.