MATERNAL FETAL RESEARCH NETWORK: DATA COORDINATING CTR

描述(改编自申请者S描述)：1986年，国家 儿童健康与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 胎儿医学单位(MFMU)网络，每个单位由多个主要 学术临床中心，数据协调中心，和研究所， 它本身。这两个网络的目的都是进行旨在 降低不良妊娠和婴儿结局的风险 最终目的是对以下问题进行良好的研究 以产科和新生儿学为基础的医疗决策。目前， MFMU网络正在规划、执行和分析多种随机化 围产期各方面的临床试验和观察性研究 预防早产、抑制早产、 先兆子痫的预防，以及孕期药物的影响。 乔治华盛顿大学生物统计中心的数据 自成立以来一直是两个网络的协调中心。这位申请人 继续为MFMU网络提供此类服务。其目的是提供 在研究设计、研究实施和统计方面的专业知识和支持 分析。调查人员将在统计方面发挥领导作用 设计研究，准备中期分析，并执行最终分析 以迅速和及时的方式。他们将准备研究文件， 包括协议、操作手册和案件报告表，并将 继续提供全面的数据处理系统，包括 分布式和集中式数据录入、数据库管理和数据质量 控制力。他们将协助调查人员准备手稿和 从研究结果中提取数据，并将数据存档，供公众查阅。 他们亦会提供行政支援，例如： 提供研究药物和实验室化验的后勤服务， 协调会议、培训课程和成果审查。他们会 有效地管理资源，以便他们能够及时开始新的学习 举止。总之，他们将作为该网络的正式成员参加， 共同的目标是了解和改善妊娠过程 和新生儿结局

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