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

项目摘要 RTI国际，作为尤尼斯·肯尼迪·施莱弗国家中心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 (一)提供科学和统计领导，促进可行、科学合理和临床相关 协议；(2)开发和支持创新、可靠、安全和本地可持续的数据管理 加强研究方案的执行和提高当地研究能力的系统； (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；以及(6) 通过全球网络的后勤通信支持，促进有效的研究开发和实施 礼宾小组和科学监督委员会(外部咨询委员会)以及数据安全和 监察委员会。RTI带来了具体的优势，将支持GN提升全球 改善低收入国家妇女和儿童健康的研究能力：(1)经过证实的科学 过去15年在GN领导层方面的合作，220多家公司证明了这一点 GN合作手稿和McClure博士通过以下方式扩展GN能力的合作 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 条目和管理工具，将(A)确保快速解决错误的高质量数据，(B)提供 创造性地解决农村地区的药品分销等挑战，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；以及(3)研究设计方面的统计专门知识 这为GN提供了创新的群集式和个人随机化设计和质量改进 方法，以解决独特的科学、实施、文化和伦理问题 GN。

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.