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)网络创建于1986年，目的是进行产科和围产期医学的临床研究。该网络由多个主要学术临床中心、一个数据协调中心和研究所本身组成。研究主要是随机试验，但也有观察性研究，目的是减少与早产、胎儿发育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、具有成本效益的产科实践提供理论基础。数据协调中心是这一协作努力中至关重要的一部分。协调中心的总体目的是确保研究旨在最大限度地减少偏见，以完整的方式进行，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，确保遵守有关保护人类受试者的规定，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，并监测数据以及对研究对象遵守协议和保留的情况。对于随机试验，协调中心创建随机化系统，为负责试验患者安全的独立数据和安全监测委员会准备中期报告，并向FDA提交报告， 如果该机构正在监督一场审判。协调中心对数据进行最终分析，协助临床中心调查人员准备出版物，并根据NIH政策协调数据集和资源的共享。协调中心促进了各中心和NIH之间的沟通，并提供了一个安全的内部网站，用于共享信息，此外还安排会议、电话会议和视频会议。最后，协调中心负责获得进行研究所需的用品和服务，如研究药物和筛查实验室，并向与研究对象的招募和后续行动相关的中心付款。

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 criticaly important part of this collaborative effort. The overall purpose of the coordinating center is to mal<e 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 dat 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.