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

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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.