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

数据协调中心-NICHD合作多中心母婴医学单位研究网

基本信息

批准号：
9812025
负责人：
Rebecca Gersnoviez Clifton
金额：
$ 1412.48万
依托单位：
GEORGE WASHINGTON UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
1998
资助国家：
美国
起止时间：
1998-04-15 至 2021-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9812025
关键词：
37 weeks gestation Academic Medical Centers Address Adherence Adult Agreement Annual Reports Birth Budgets Cessation of life Charge Child Child Health Clinical Clinical Investigator Clinical Research Collaborations Communication Data Data Analyses Data Coordinating Center Data Reporting Data Set Database Management Systems Development Devices Discipline of obstetrics Drug Screening Ensure Environment Equipment and Supplies Family Fetal Growth Fetal Research Follow-Up Studies Funding Goals Health Informed Consent Institutes Institutional Review Boards Intervention Laboratories Life Life Style Logistics Manuals Maternal-Fetal Medicine Units Network Medicine Methods Monitor Morbidity - disease rate Mothers Multicenter Studies National Institute of Child Health and Human Development Nulliparity Obesity Obesity Epidemic Observational Study Online Systems Outcome Pharmaceutical Preparations Pharmacy facility Placebos Policies Population Pregnancy Pregnancy Complications Pregnancy Outcome Pregnant Women Premature Birth Preparation Procedures Prophylactic treatment Protocols documentation Public Health Publications Quality Control Randomized Reading Regulation Reporting Research Research Design Research Personnel Resources Risk Running Safety Sampling Scheme Secure Services Structure Study Subject System Time Training United States United States National Institutes of Health Update Uterus Videoconferencing Woman Work adverse pregnancy outcome cost effective data management data resource design disability evidence base fetal fetal programming flexibility genetic makeup human subject protection improved infant morbidity meetings mortality risk patient safety payment perinatal medicine premature prevent protocol development public health relevance randomized trial recruit research study secondary analysis support network symposium user-friendly web site working group

项目摘要

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.

描述（由申请人提供）：尤尼斯·肯尼迪·施赖弗国家儿童健康和人类发展研究所母胎医学中心 (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。该研究主要是随机试验，也包括观察性研究，旨在减少与早产、胎儿生长异常和母体并发症相关的孕产妇、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依据。。数据协调中心是这种协作工作中至关重要的一部分。协调中心的总体目标是确保研究旨在最大限度地减少偏见、诚信地进行，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循程序。协调中心提供数据输入和管理系统并监控数据，以及研究受试者对协议的遵守和保留。对于随机试验，协调中心创建随机化系统，为负责试验中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 报告，如果该机构正在监督审判。协调中心对数据进行最终分析，协助临床中心研究人员准备出版物，并根据 NIH 政策协调数据集和资源的共享。协调中心促进各中心和 NIH 之间的沟通，除了安排会议、电话会议和视频会议外，还提供安全的内部网站来共享信息。最后，协调中心负责获取进行研究所需的用品和服务，例如研究药物和筛选实验室，并向与研究受试者的招募和随访相关的中心付款。