MATERNAL FETAL RESEARCH NETWORK: DATA COORDINATING CTR

描述（改编自申请人的描述）：1986年，国家 儿童健康和人类发展研究所创建了两个多中心 围产期研究网络、新生儿研究网络和产妇研究网络 胎儿医学单位（MFMU）网络，每个网络由一些主要的 学术临床中心，数据协调中心和研究所， 本身 这两个网络的目的是进行临床研究， 降低不良妊娠和婴儿结局的风险， 最终目的是为一系列进行良好的研究作出贡献， 这是产科和妇产科医疗决策的基础。 目前， MFMU网络正在计划、实施和分析多个随机 围产期各方面的临床试验和观察性研究 药物如早产预防，早产抑制， 先兆子痫的预防，以及药物在妊娠中的作用。 乔治华盛顿大学生物统计学中心一直是数据 自成立以来一直是两个网络的协调中心。 此申请人 继续为MFMU网络提供服务。 目的是提供 研究设计、研究实施和统计方面的专业知识和支持 分析. 研究人员将在统计方面发挥领导作用， 研究设计，准备中期分析，并进行最终分析 迅速和及时的方式。 他们将准备研究文件， 包括方案、操作手册和病例报告表，并将 继续提供全面的数据处理系统，包括 分布式和中央数据输入、数据库管理和数据质量 控制 他们将协助调查人员编写手稿， 从研究结果中摘录，并将数据存档供公众查阅。 他们还将提供行政支助，例如： 提供研究药物和实验室检测的后勤服务， 协调会议、培训班和成果审查。 他们将 有效地管理资源，以便他们能够及时开始新的研究 方式 总之，他们将作为网络的正式成员参加， 共同的目标是了解和改善怀孕过程， 及新生儿结局

DESCRIPTION (Adapted from Applicant s Description): In 1986, the National Institute of Child Health and Human Development created two multicenter perinatal research networks, the Neonatal Research Network and the Maternal Fetal Medicine Units (MFMU) Network, each consisting of a number of major academic clinical centers, a data coordinating center, and the Institute, itself. The purpose of both Networks was to conduct clinical research aimed at reducing the risk of adverse pregnancy and infant outcome with the ultimate purpose of contributing to the body of well-conducted studies on which to base medical decisions in obstetrics and neonatology. At present, the MFMU Network is planning, conducting and analyzing multiple randomized clinical trials and observational studies in various aspects of perinatal medicine such as preterm birth prevention, preterm labor suppression, prevention of preeclampsia, and the effects of drugs in pregnancy. The George Washington University Biostatistics Center has been the Data Coordinating Center for both Networks since its inception. This applicant continues to serve as such for the MFMU Network. The purpose is to provide expertise and support in study design, study conduct and statistical analysis. The investigators will provide statistical leadership in the design of the study, prepare interim analyses, and perform final analyses in an expeditious and timely manner. They will prepare study documents, including protocols, manuals of operations and case report forms, and will continue to provide a comprehensive data processing system including distributed and central data entry, data base management and data quality control. They will assist investigators in preparation of manuscripts and abstracts from study results and will archive the data for public access. They will also provide administrative support such as: arrangement of logistical services for provision of study drugs and laboratory assays, coordination of meetings, training sessions and outcome reviews. They will manage resources effectively, so that they can start new studies in a timely manner. In summary, they will participate as full members of the Network, with the common goal of understanding and improving the course of pregnancy and neonatal outcome