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：
10261684
负责人：
Rebecca Gersnoviez Clifton
金额：
$ 306.5万
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/10261684
关键词：
37 weeks gestation Academic Medical Centers Address Adherence Adult Agreement Annual Reports Birth Budgets Cerebral Palsy Cessation of life Charge Child Child Health Clinical Clinical Investigator Collaborations Communication Data Data Analyses Data Coordinating Center Data Management Resources 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 Instruction 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 Principal Investigator 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 clinical center cost effective 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 randomized trial recruit research study secondary analysis support network symposium user-friendly web site working group

项目摘要

The Eunice Kennedy Srtr/Ver National Institute of Ciiiid Healtii and Hunnan Development Maternal-Fetal Medicine Units (MFMU) Networl< was created in 1986 to conduct clinical researcti studies in obstetrics and perinatal medicine. Tiie Networl< consists of a number of major academic clinical centers, a data coordinating center, and tlie Institute itself. Tlie research) studies, principally randomized trials but also observational studies, are aimed at reducing maternal, fetal and infant morbidity related to preterm birtti, fetal growtli abnormalities and maternal complications and to provide ttie rationale for evidence-based, cost- effective, obstetric practice. Ttie data coordinating center is a critically 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 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. RELEVANCE (See instructions): The relevance ofthe proposed research to public health is clear and direct. The results ofthe MFMU Network's studies can benefit potentially pregnant women and their children worldwide, by finding methods to screen for problems in pregnancy, treatments that for pregnant women that improve their and their children's health, and especially finding treatments that can help lessen the problem of babies being born too early.

Eunice Kennedy Srtr/Ver 国立卫生健康与湖南母婴发展研究所 Medicine Units (MFMU) Network< 成立于 1986 年，旨在开展产科和医学领域的临床研究围产期医学。 Tiie Network<由多个主要学术临床中心、数据协调中心和研究所本身。研究）研究，主要是随机试验，但也观察性研究，旨在减少与早产、胎儿相关的孕产妇、胎儿和婴儿发病率生长异常和孕产妇并发症，并为基于证据的、成本- 有效的产科实践。数据协调中心是这项协作工作中至关重要的一部分。总体目的协调中心确信这些研究旨在最大限度地减少偏倚，并且是在以下情况下进行的：完整性，并对结果进行适当的分析和解释，以确保结论的有效性。这协调中心负责协助临床研究者制定方案，制定确保遵守有关保护人类受试者的法规，创建数据表格和手册程序，以便准确收集数据并培训临床中心工作人员遵循程序。协调中心提供数据录入和管理系统并监控数据，以及对方案的遵守和研究对象的保留。对于随机试验，协调中心创建随机化系统，为独立数据和准备中期报告安全监察委员会负责试验中患者的安全，并向试验报告 FDA，如果该机构正在监督试验。协调中心对数据进行最终分析并协助临床中心研究人员准备出版物，并协调共享根据 NIH 政策的数据集和资源。协调中心促进各部门之间的沟通中心和 NIH，并提供一个安全的内部网站来共享信息，此外还安排会议、电话会议和视频会议。最后由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研究，以及向与研究招募和后续工作相关的中心付款科目。相关性（参见说明）：拟议研究与公共卫生的相关性是明确和直接的。 MFMU 的结果网络的研究可以通过寻找方法使全世界的潜在孕妇及其孩子受益筛查怀孕期间的问题，为孕妇提供改善其状况的治疗方法儿童的健康，特别是寻找有助于减轻婴儿出生问题的治疗方法早期的。