Stillbirth Network

描述（由申请人提供）：RTI International （RTI）是Research Triangle Institute的商标名，提议成为NICHD“美国死产范围和原因研究”网络的数据协调和分析中心（DCAC）。rtr作为DCAC在多种多地点临床和行为研究中的29年经验，许多在孕产妇和儿童健康领域，使我们能够认识到DCAC必须承担的各种责任，以成功满足多地点研究不断变化的需求。这些职责包括但不限于：(1)参与方案制定；(2)开发和实施研究范围内的通信网络；(3)提供复杂的数据收集和管理系统，以响应研究的新需求；(4)根据需要支持研究的后勤工作；(5)协助培训现场人员了解标准研究程序；(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方面的领导，(8)编写常规和临时报告，以满足临床站点、NICHD、指导委员会、咨询委员会和数据安全和监测委员会的需要，以及(9)通过出版物和演示文稿帮助传播研究结果。该项目的主要工作人员Corette Parker博士和Matthew Koch博士都是高级生物统计学家，负责流行病学支持项目。他们每个人都有超过15年的管理DCAC活动和领导多地点研究统计任务的经验。Koch博士的医学学位为该网络的统计和医学组成部分提供了额外的标志。随着网络需求的变化，我们将能够从具有不同背景的庞大员工队伍中获得所需的专业知识，以补充我们的基础员工，以应对研究的预期需求。RTI位于马里兰州Rockville的NICHD隔壁的办公室提供了与NICHD工作人员互动所需的会议空间。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，特别投入到统计设计和分析、数据获取方法、数据管理和处理、质量控制以及现场数据收集和数据管理人员的培训。

DESCRIPTION (provided by applicant): 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.