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

• 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
• 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' 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

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.

项目摘要 RTI International，作为Eunice Kennedy Shriver National的拟议数据协调中心（DCC） 儿童健康与人类发展研究所（NICHD）全球网络（GN）将提供科学和 运营资源以最大化GN研究的科学生产力和公共卫生影响 多个低收入国家的各种研究环境的合作。为了实现这一目标，RTI将 （1）提供科学和统计领导，以促进可行的，科学的声音和临床上的相关性 协议； （2）开发和支持创新，健壮，安全和本地可持续的数据管理 系统（DMS）增强了研究方案的实施并提高本地研究能力； （3）制定有效的数据监控和安全报告，以促进研究管理和监督； （4） 通过严格的分析以及后勤和社论来促进合作，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，存储和跟踪； （6） 通过后勤沟通支持，促进有效的研究开发和实施 协议团队和科学监督委员会（外部顾问委员会）和数据安全以及 监视板。 RTI带来了特定的优势，这些优势将支持GN的使命来增强全球 改善低收入国家妇女和儿童健康的研究能力：（1） 在过去15年中，GN领导的合作，超过220年 合作GN手稿和McClure博士的合作，以扩大GN的能力 与外部资金来源合作； （2）一组最先进的，灵活的，已建立的分布式数据 将（a）确保以快速错误解决的高质量数据的进入和管理工具，（b）提供 针对农村地区药物分配等挑战的创造性解决方案，（c）为现场工作人员提供学习 提高科学质量的管理和报告工具； （3）研究设计的统计专业知识 这为GN提供了创新的集群和单独随机的设计以及质量改进 解决独特的科学，实施，文化和道德问题的方法 GN。