Global Network for Women's and Children's Health Research Data Coordinating Center

全球妇女和儿童健康网络研究数据协调中心

基本信息

批准号：
10202674
负责人：
Elizabeth M McClure
金额：
$ 162.96万
依托单位：
RESEARCH TRIANGLE INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-07-01 至 2023-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10202674
关键词：
Address Child Child Health Childhood Clinic Clinical Clinical Research Clinical Trials Data Monitoring Committees Collaborations Communication Country Data Data Analyses Data Collection Data Coordinating Center Data Management Resources Data Set Developing Countries Development Ensure Environment Equipment and Supplies Ethical Issues Fetal Mortality Statistics Fostering Funding Agency Health Health Policy Individual International Intervention Knowledge Leadership Logistics Manuscripts Maps Maternal Mortality Mission Monitor Multi-site clinical study National Institute of Child Health and Human Development Neonatal Mortality Outcome Pharmaceutical Preparations Pregnancy Procedures Productivity Protocols documentation Public Health Publications Randomized Recording of previous events Reporting Research Research Design Research Infrastructure Research Personnel Resolution Resources Safety Secure Services Site Statistical Data Interpretation System Time Training Translating Woman Women&apos s Health clinical practice clinically relevant data management data quality design distributed data drug distribution editorial experience flexibility improved innovation low and middle-income countries low income country member mortality operation research study rural area skills sound tool

项目摘要

Project Summary RTI International, as the proposed data coordinating center (DCC) for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Global Network (GN), will provide the scientific and operational resources to maximize the scientific productivity and public health impact of the GN research collaborations across diverse research settings in multiple low-income countries. To achieve this aim, RTI will (1) provide scientific and statistical leadership to facilitate feasible, scientifically sound, and clinically relevant protocols; (2) develop and support innovative, robust, secure, and locally sustainable data management systems (DMSs) that enhance the implementation of the study protocols and increase local research capacity; (3) develop effective data monitoring and safety reports that facilitate study management and oversight; (4) facilitate collaborative, high-quality GN study publications through rigorous analyses and logistical and editorial support; (5) coordinate the acquisition, storage, and tracking of study drugs, equipment, and supplies; and (6) promote efficient study development and implementation through logistical communication support of the GN protocol teams and the Scientific Oversight Committee (external advisory board) and the Data Safety and Monitoring Board. RTI brings specific strengths that will support the GN's mission to enhance the global research capacity to improve health of women and children in low-income countries: (1) proven scientific collaboration in the leadership of the GN over the past 15 years as demonstrated by the more than 220 collaborative GN manuscripts and the collaboration of Dr. McClure in extending GN capacity through collaboration with external funding sources; (2) a set of state-of-the art, flexible, established distributed data entry and management tools that will (a) ensure high-quality data with rapid error resolution, (b) provide creative solutions to challenges like drug distribution in rural areas, and (c) provide site staff with study management and reporting tools that enhance the scientific quality; and (3) statistical expertise in study design that has provided the GN with innovative cluster- and individually randomized designs and quality improvement approaches that address the unique scientific, implementation, cultural, and ethical issues encountered by the GN.

项目概要 RTI International，作为尤尼斯·肯尼迪·施赖弗国家数据协调中心 (DCC) 儿童健康和人类发展研究所 (NICHD) 全球网络 (GN) 将提供科学和最大限度地提高 GN 研究的科学生产力和公共卫生影响的运营资源多个低收入国家不同研究环境的合作。为了实现这一目标，RTI 将 (1) 提供科学和统计领导，以促进可行、科学合理和临床相关协议； (2) 开发和支持创新、稳健、安全和本地可持续的数据管理加强研究方案实施并提高当地研究能力的系统（DMS）； (3) 制定有效的数据监测和安全报告，以促进研究管理和监督； (4) 通过严格的分析以及后勤和编辑，促进协作、高质量的 GN 研究出版物支持; (5) 协调研究药物、设备和用品的获取、储存和跟踪；和（6）通过 GN 的后勤通信支持促进高效的研究开发和实施协议小组和科学监督委员会（外部顾问委员会）以及数据安全和监察委员会。 RTI 带来的具体优势将支持 GN 的使命，即增强全球改善低收入国家妇女和儿童健康的研究能力：(1) 经证实的科学依据过去 15 年中 GN 领导层的合作已在 220 多个 GN 协作手稿以及 McClure 博士在扩展 GN 能力方面的合作与外部资金来源的合作； (2) 一组最先进的、灵活的、既定的分布式数据录入和管理工具将 (a) 确保高质量数据并快速解决错误，(b) 提供应对农村地区药品分发等挑战的创造性解决方案，以及 (c) 为现场工作人员提供研究提高科学质量的管理和报告工具； (3) 研究设计方面的统计专业知识为 GN 提供了创新的集群和单独随机设计以及质量改进解决独特的科学、实施、文化和伦理问题的方法 GN。