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

Project Summary/Abstract To improve women’s and children’s health and make progress in addressing the U.N.’s Sustainable Development Goals (SDGs), there is a need to continue researching sustainable, cost-effective health interventions and strengthening research infrastructure and public health intervention capabilities in developing countries. The NICHD Global Network (GN) is critical to helping the U.S. government address the SDGs to reduce maternal mortality and end preventable newborn and child mortality. There is a crucial need for an independent Data Coordinating Center (DCC) to provide statistical and operational expertise that helps the GN complete high-impact research to influence policy. RTI has been the GN’s DCC since 2001 and proposes to continue in this role for the next cycle. We will maximize the global impact of the GN and ensure a productive and accessible GN by collaborating with study investigators—both within and outside the Network—to develop rigorous and relevant Network research protocols and budgets. We will ensure seamless incorporation of research protocols developed by both GN and non-Network investigators through systems developed to inform study design using knowledge of the GN sites. (1) Optimize the scientific quality and operational efficiency of GN studies by supporting protocol design, training, implementation, and study monitoring; developing rigorous statistical analysis plans; incorporating common data elements; and effectively procuring external services, as needed, to support the research implementation. (2) Ensure high- quality data collection and data management, rigorous monitoring of study progress, quality, and participant safety. (3) Maximize the validity and scientific impact of Network research by providing timely, accurate statistical analyses of GN research to support publication of study results; ensuring timely dissemination and public sharing of data at study completion; and supporting study oversight by the Data Safety Monitoring Board, the Steering Committee, research units, NICHD. (4) Enhance the efficiency, productivity, and outreach of Network operations to Network and non-Network investigators by providing broad logistical support, including telecommunications, meeting coordination and organization, web-based internal and external communication systems, and regulatory support. Dr. Elizabeth McClure, the proposed PI, has extensive experience in maternal and newborn studies, and will be assisted by senior research staff with significant GN experience. This application has unique strengths to help advance the GN research agenda: (1) a highly qualified, collaborative PI and staff with in-depth knowledge; (2) proven track record of scientific productivity and leveraging the GN infrastructure to address emerging issues to advance NICHD scientific goals; (3) robust data systems customized for the GN to ensure data quality for harmonized research; (4) experts in biostatistics, epidemiology, community health, nutrition, infant development, and health economics; and (5) a flexible administrative structure to help realize the NICHD vision to optimize the GN.