A Request for Applications (RFA) is proposed entitled “Global Network for Women’s and Children’s Health Research Data Coordinating Center (DCC).” The proposed RFA will use the NIH Cooperative Clinical Research Agreement (U01) grant award mechanism.
This FOA issued by the Eunice Kennedy Shriver National Institute of Child Health and Human Development solicits grant applications from institutions/organizations willing to participate with the NICHD as the Data Coordinating Center under a cooperative agreement in an ongoing multi-center international research network designed to perform randomized clinical trials, using common protocols, to reduce the major risk of maternal, neonatal, infant, and early childhood mortality and significant morbidity in low income countries.
The GN comprises 7 Research Units (RUs) that work to collaboratively to design, develop, and conduct multiple protocols evaluate and implement evidence-based health interventions conduct formative and translational research studies This initiative is for competitive funding of a Data Coordinating Center that will have the primary responsibility of supporting the research endeavors of the Network.
The Data Coordinating Center will collaborate in the development, implementation, and monitoring of Network protocols; provide data management and transmission, including preparation of data and safety reports for the Data and Safety Monitoring Board, Network committees, public data files, and manuscripts for publication; collaborate in the analysis of data and publication of results of Network studies; provide services for acquisition and storage of study drugs and placebos and other equipment and supplies; and provide logistical support necessary to run an efficient and productive Network. Given the collaborative nature of the Global network substantial involvement of the NICHD program staff is anticipated above and beyond the levels required for traditional program management and stewardship of awards.
The objective is to fund one successful applicant under a cooperative agreement in an ongoing multi-center international research network designed to perform randomized clinical trials .The awardee is expected to collaborate with the External Advisory Board, Research Unit Principal Investigators, Senior Foreign Investigators, NICHD Program Scientists and other participating NICHD staff, in the design and conduct of protocols, analysis of data, and reporting results from GN research. The Data Coordinating Center plays a pivotal role in data management and analysis, statistical expertise, and logistical services required by the Global Network. The GN Data Coordinating Center has the responsibility to provide the Network's organizational, statistical, and technical support, including the shared funding of information technology staff and site training, and regulatory adherence.
Global Network for Women's and Children's Health Research
Pregnancy and Perinatology Branch
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