Stillbirth Network

描述(由申请者提供)：RTI International(RTI)是三角研究所的商标名，计划成为NICHD“美国死胎的范围和原因研究”网络的数据协调和分析中心(DCAC)。RTRS 29年担任多站点临床和行为研究的DCAC的经验使我们认识到DCAC必须承担的各种责任，以成功满足多站点研究的不断变化的需求。这些职责包括但不限于：(1)参与制定方案，(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，以回应研究的新需求，(4)根据需要支持研究的后勤，(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程序和质量保证程序，(7)提供生物统计和数据管理领导，(8)编制满足临床站点、NICHD、指导委员会、咨询委员会和数据安全和监测委员会；以及(9)通过出版物和演示文稿帮助传播研究结果。为该项目建议的主要工作人员科雷特·帕克博士和马修·科赫博士都是高级生物统计学家，在流行病学方面有支持计划。他们每个人都有超过15年的管理DCAC活动和领导多站点研究的统计任务的经验。科赫博士的医学学位在该网络的统计和医学组成部分之间提供了额外的徽章。随着网络需求的变化，我们将能够为我们的基地工作人员提供所需的专业知识，这些专业知识来自我们拥有丰富背景的员工，这些员工满足了研究的预期需求。RTI在马里兰州罗克维尔的NICHD隔壁的办公室提供与NICHD工作人员互动所需的会议空间。在该项目的第一年，技术创新中心将与NICHD和指导委员会合作，制定研究方案，特别是对统计设计和分析、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工作人员的培训。

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.