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

全球妇女网络

• 批准号: 9328202
• 负责人: Elizabeth M McClure
• 金额: $ 20万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-09 至 2018-03-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9328202
• 关键词: Address; Adrenal Cortex Hormones; Child; Child health care; Childhood; Clinical Trials Data Monitoring Committees; Collaborations; Communication; Computer software; Computers; Country; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Quality; Developing Countries; Development; Discipline of obstetrics; Emergency Situation; Ensure; Environment; Equipment; Equipment and Supplies; Ethical Issues; Exhibits; Foundations; Funding; Funding Agency; Goals; Health; Information Systems; International; Internet; Leadership; Learning; Manuscripts; Maps; Mission; Monitor; Morbidity - disease rate; Multi-Institutional Clinical Trial; National Institute of Child Health and Human Development; Newborn Infant; Participant; Performance; Pharmaceutical Preparations; Productivity; Protocols documentation; Public Health; Publications; Publishing; Randomized; Real-Time Systems; Recording of previous events; Recruitment Activity; Registries; Reporting; Research; Research Design; Research Personnel; Resolution; Resources; Safety; Secure; Services; Site; System; Time; Training; Woman; Women' s Health; clinically relevant; data management; design; distributed data; drug distribution; editorial; experience; flexibility; human subject protection; improved; innovation; low income country; meetings; member; minority children; mortality; neonatal care; operation; public health relevance; rural area; social media; sound; symposium; tool; transmission process; web site

DESCRIPTION (provided by applicant): RTI International (RTI), 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, scientificaly 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 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 11 years as demonstrated by the more than 110 collaborative GN manuscripts and the collaboration of E. 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 difficult problems 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.

描述（由申请人提供）：RTI International （RTI）作为Eunice Kennedy Shriver国家儿童健康与人类发展研究所（NICHD）全球网络（GN）的拟议数据协调中心（DCC），将提供科学和业务资源，以最大限度地提高GN研究合作在多个低收入国家的不同研究环境中的科学生产力和公共卫生影响。为了实现这一目标，RTI将(1)提供科学和统计方面的领导，以促进可行、科学合理和临床相关的方案；(2)开发和支持创新、稳健、安全和本地可持续的数据管理系统（dms），以加强研究方案的实施并提高本地研究能力；(3)制定有效的数据监测和安全报告，方便研究管理和监督；(4)通过严格的分析、后勤和编辑支持，促进协作性、高质量的GN研究出版物；（五）协调研究药品、设备和耗材的获取、储存和跟踪；(6)通过GN协议小组、外部咨询委员会和数据安全和监测委员会的后勤沟通支持，促进有效的研究开发和实施。RTI带来了具体的优势，将支持GN的使命，即提高全球研究能力，改善低收入国家妇女和儿童的健康：(1)在过去11年里，GN领导的科学合作得到了证实，这一点由110多份GN合作手稿和E. McClure通过与外部资金来源合作扩大GN能力所证明；(2)一套先进的、灵活的、已建立的分布式数据输入和管理工具，这些工具将(a)确保高质量的数据，并快速解决错误；(b)为农村地区药品分配等难题提供创造性的解决方案；(c)为现场工作人员提供提高科学质量的研究管理和报告工具；(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个体随机设计和质量改进方法，解决了GN遇到的独特的科学、实施、文化和伦理问题。