Stillbirth Network

RTI国际(RTI)，研究三角研究所的商标名称，建议成为数据 NICHD“年死产范围及原因研究”协调分析中心 美国“网络。RTRS为一家多站点公司担任DCAC长达29年的经验 临床和行为研究，许多在妇幼健康领域，使我们能够认识到 DCAC为成功满足不断变化的需求而必须承担的各种职责 一项多点研究。这些职责包括但不限于：(1)参与协议 发展，(2)发展和实施全研究范围的通信网络，(3)提供 完善的数据收集和管理系统，可满足 学习，(4)根据需要支持学习的后勤，(5)协助培训现场人员的标准 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 满足临床站点需求的特设报告、NICHD、指导委员会、咨询 委员会和数据安全及监察委员会；及(9)协助宣传 通过出版物和演示文稿进行学习。该项目的主要工作人员，科雷特·帕克博士，派， 和共同派的马修·科赫博士都是高级生物统计学家，都有流行病学方面的支持项目。 他们每个人都有超过15年的管理DCAC活动和领导多站点统计任务的经验 学习。科赫博士的医学学位在统计学和医学之间提供了额外的徽章 网络的组件。随着网络需求的变化，我们将能够补充我们的基础 拥有所需专业知识的员工，他们拥有大量背景丰富的员工，能够满足预期需求 这项研究的结果。RTI在马里兰州罗克维尔的NICHD隔壁的办公室根据需要提供会议空间 与NICHD工作人员的互动。 在项目的第一年，RTI将与NICHD和指导委员会合作，以 制定研究方案，对统计设计和分析、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.