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

描述(由申请人提供)：RTI国际(RTI)作为尤尼斯·肯尼迪·施莱弗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)，将提供科学和操作资源，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)提供科学和统计领导，以促进可行的、科学合理的和临床相关的方案；(2)开发和支持创新的、稳健的、安全的和当地可持续的数据管理系统(DMS)，以加强研究方案的实施和提高当地的研究能力；(3)开发有效的数据监测和安全报告，促进研究管理和监督；(4)通过严格的分析以及后勤和编辑支持，促进协作的高质量GN研究出版物；(5)协调研究药物、设备和用品的获取、存储和跟踪；以及(6)通过向全球网络礼宾小组以及外部咨询委员会和数据安全和监测委员会提供后勤通信支助，促进有效开展和实施研究。RTI带来的具体优势将支持GN加强全球研究能力以改善低收入国家妇女和儿童健康的使命：(1)过去11年来GN领导的科学合作得到证实，110多份合作GN手稿和E.McClure通过与外部资金来源合作扩大GN能力证明了这一点；(2)一套先进的、灵活的、成熟的分布式数据输入和管理工具，它将(A)确保高质量的数据和快速解决错误，(B)为农村地区的药品分配等难题提供创造性的解决方案，以及(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；以及(3)研究设计方面的统计专业知识，为全球网络提供创新的群组和个人随机设计和质量改进方法，以解决全球网络遇到的独特的科学、实施、文化和伦理问题。

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.