Data Coord Ctr-NICHD Cooperative Multicenter Maternal Medicine Units Research Net

描述（由申请人提供）：尤尼斯·肯尼迪·施莱弗国家儿童健康和人类发展研究所母胎医学单位（MFMU）网络成立于1986年，旨在开展产科和围产期医学的临床研究。该网络由一些主要的学术临床中心、一个数据协调中心和研究所本身组成。这些研究，主要是随机试验，但也有观察性研究，旨在减少与早产、胎儿生长异常和产妇并发症有关的孕产妇、胎儿和婴儿发病率，并为循证、成本效益高的产科实践提供依据。数据协调中心是这一协作工作的重要组成部分。协调中心的总体目的是确保研究的设计能够最大限度地减少偏倚，完整地进行研究，并对结果进行适当的分析和解释，以确保结论的有效性。协调中心负责协助临床研究人员制定方案，确保遵守有关人体受试者保护的规定，创建数据表格和程序手册，以便准确收集数据，并培训临床中心工作人员遵守程序。协调中心提供数据录入和管理系统，并监测数据，以及研究对象对方案的遵守和保留。对于随机试验，协调中心创建随机化系统，为独立的数据和安全监测委员会准备中期报告，该委员会负责试验患者的安全，并向FDA报告，

DESCRIPTION (provided by applicant): The Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units (MFMU) Network was created in 1986 to conduct clinical research studies in obstetrics and perinatal medicine. The Network consists of a number of major academic clinical centers, a data coordinating center, and the Institute itself. The research) studies, principally randomized trials but also observational studies, are aimed at reducing maternal, fetal and infant morbidity related to preterm birth, fetal growth abnormalities and maternal complications and to provide the rationale for evidence-based, cost- effective, obstetric practice. The data coordinating center is a critically important part of this collaborative effort. The overall purpose of the coordinating center is to make sure that the studies are designed to minimize bias, are conducted with integrity, and the results analyzed and interpreted appropriately to ensure the validity of the conclusions. The coordinating center is responsible for assisting the clinical investigators with developing the protocol, making sure that regulations regarding protection of human subjects are followed, creating data forms and a manual of procedures so that the data are collected accurately and training the clinical center staff to follow the procedures. The coordinating center provides a data entry and management system and monitors the data, as well as adherence to the protocol and retention of the study subjects. For randomized trials, the coordinating center creates the randomization system, prepares interim reports for the independent Data and Safety Monitoring Committee that is responsible for the safety of the patients on the trial, and reports for the FDA, if that agency is overseeing a trial. The coordinating center conducts the final analysis of the data and assists the clinical center investigators with the preparation of publications, and coordinates sharing of datasets and resources per NIH policy. The coordinating center facilitates communication among the centers and NIH, and provides a secure internal website for sharing information, in addition to arranging meetings, conference calls and videoconferencing. Finally the coordinating center is in charge of obtaining supplies and services, such as study drug and screening laboratories, necessary for the conduct of the studies, and for making payments to the centers associated with recruitment and follow-up of the study subjects.