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

项目摘要 RTI International，作为Eunice Kennedy Shriver National的拟议数据协调中心（DCC） 儿童健康和人类发展研究所（NICHD）全球网络（GN）将提供科学和 运营资源，以最大限度地提高GN研究的科学生产力和公共卫生影响 在多个低收入国家的不同研究环境中开展合作。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、科学合理的和临床相关的 协议;（2）开发和支持创新的、强大的、安全的和本地可持续的数据管理 加强研究方案的实施和提高当地研究能力的灾害管理系统; (3)制定有效的数据监测和安全性报告，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、设备和供应品的获取、储存和跟踪;以及（6） 通过GN的后勤通信支持，促进有效的研究开发和实施 方案团队和科学监督委员会（外部咨询委员会）以及数据安全和 监测委员会。RTI带来了具体的优势，将支持GN的使命，以提高全球 改善低收入国家妇女和儿童健康的研究能力：⑴经证实的科学 在过去的15年里，GN领导层的合作，如220多个 协作GN手稿和麦克卢尔博士的合作，通过 与外部资金来源合作;（2）一套最先进、灵活、已建立的分布式数据 输入和管理工具，将（a）确保高质量的数据，快速解决错误，（B）提供 创造性地解决农村地区的药物分配等挑战，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）研究设计中的统计专业知识 这为GN提供了创新的集群和个体随机设计和质量改进 这些方法解决了科学、实施、文化和伦理方面的独特问题， 政府公告

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.