Administrative Core for the Stillbirth Research Consortium Data Coordinating Center

Administrative Core: Modified Abstract A well-coordinated, unified approach is crucial to support basic, translational, clinical, and data sciences research to generate knowledge for advancement in stillbirth-related research and to identify ways to decrease the incidence of stillbirth. To meet the challenge of implementing the Stillbirth Research Consortium, the Data Coordinating Center (DCC) requires an experienced Administrative Core to lead and coordinate across the Innovative Technologies Core, Research Centers, the Steering Committee, single institutional review board (sIRB), National Institutes of Health (NIH)/Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and the scientific community. In response to RFA-HD-25-011, RTI International will achieve the following specific aims as the DCC Administrative Core: (1) Provide effective organizational capabilities to provide overall leadership for the Stillbirth Research Consortium DCC, including aiding in the implementation and development of single site and common protocols; providing administrative oversight; data harmonization; and ensuring coordination across the Research Centers, non-Consortium sites, and Consortium components; and (2) Facilitate effective cross-Consortium communication, collaboration, and consensus building across the Research Centers and Consortium components through supporting reoccurring videoconference calls and investigator meetings, a Consortium website that will include interactive dashboards (enrollment and biospecimen tracking), and implementation of biospecimen tracking tools. The DCC has a long history of successful collaboration on completed and ongoing perinatal studies, including those focused on stillbirth. As the DCC for more than 40 multicenter collaborative research networks, RTI has served as the administrative lead for hundreds of multisite studies. Based on this experience, the Administrative Core will facilitate the success of the Consortium and enhance its scientific impact by building on these unique strengths: (1) a state-of-the-art infrastructure of flexible tools, processes, and systems, some of which were developed by RTI and will be further customized to meet the unique needs of the Consortium; (2) an administrative structure that provides staffing flexibility to optimally deploy personnel resources and respond quickly to changing Consortium needs; and (3) a proven track record of collaboration and scientific productivity with Research Centers of varying levels of experience and expertise while achieving the same standard of quality. RTI’s approach as the Administrative Core has many innovations such as (1) creating a branding strategy for the Consortium to increase visibility and dissemination of results; (2) tailoring efforts to increase enrollment and to enhance scientific impact; (3) developing a website portal to serve as communication platform with interactive dashboards; and (4) using consensus building and decision-making tools. Project Number: 1UM2HD119552-01 | Fiscal Year: 2025 | NIH Institute/Center: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Principal Investigator: Jamie Newman | Institution: RESEARCH TRIANGLE INSTITUTE, RESEARCH TRIANGLE PARK, NC | Award Amount: $716,534 | Activity Code: UM2 | Study Section: Special Emphasis Panel[ZHD1 DSR-L (51)] View on NIH RePORTER: https://reporter.nih.gov/project-details/1UM2HD11955201