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

全球妇女网络

• 批准号: 8842144
• 负责人: Elizabeth M McClure
• 金额: $ 254.92万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-08-17 至 2016-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8842144
• 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; Human Development; Information Systems; Institutes; International; Internet; Leadership; Learning; Low income; Manuscripts; Maps; Minority; 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; Solutions; System; Telephone; Time; Training; Woman; Women' s Health; clinically relevant; data management; design; distributed data; drug distribution; editorial; experience; flexibility; human subject protection; improved; innovation; meetings; member; mortality; neonatal care; operation; public health relevance; rural area; social; 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) 作为尤尼斯·肯尼迪·施赖弗国家儿童健康和人类发展研究所 (NICHD) 全球网络 (GN) 拟议的数据协调中心 (DCC)，将提供科学和可操作的数据资源，以最大限度地提高 GN 研究合作在多个低收入国家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) 提供科学和统计领导力，以促进可行、科学合理且临床相关的方案； (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，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支持，促进协作、高质量的 GN 研究出版物； (5) 协调研究药物、设备和用品的获取、储存和跟踪； (6) 通过 GN 协议团队、外部顾问委员会和数据安全与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 带来的具体优势将支持 GN 的使命，即增强全球研究能力，以改善低收入国家妇女和儿童的健康：(1) 过去 11 年中 GN 领导层中经过验证的科学合作，如超过 110 份 GN 合作手稿，以及 E. McClure 通过与外部资金来源合作扩展 GN 能力的合作； (2) 一套最先进的、灵活的、成熟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研究管理和报告工具，以提高科学质量；(3) 研究设计方面的统计专业知识，为 GN 提供创新的整群和单独随机设计以及质量改进方法，以解决以下问题： GN 遇到的独特的科学、实施、文化和伦理问题。