This proposal is submitted by Research Triangle Institute (RTI) and the University of North Carolina (UNC) to serve as the Data Coordinating Center (DCC) for the NICHD Global Network for Women's and Children's Health Research. A strong team of scientists including the proposed PI, Dr. T.D. Hartwell, and Co-PIs, Drs. Rao and Poole of RTI, and faculty from UNC will lead the project and will provide overall study coordination, including study design, data management, statistical analysis, materials development, biological specimen collection, training in common procedures, implementation of quality control procedures, and expertise in maternal and child health. An experienced staff of statisticians, programmers, data coordinators, epidemiologist, medical anthropologists and international and maternal and child health specialists have been assembled to support the Network. All of this staff have a great deal of experience in coordinating multicenter studies. We propose to have an Internal Management Committee oversee the DCC operations for the Network which will set up DCC Protocol Teams to work with Network Investigators on each protocol. We proposed to use computer assisted data collection methods to collect the majority of the data for the various Network protocols (e.g., Distributed Data Entry). We have used these methods in many multisite studies. Our communications network will be built around e-mail and a project web site which will be used to disseminate project reports and other information whenever possible. We propose to assist Research Units in purchasing computer equipment for the study, to coordinate training site staff in each country in assessment procedures and intervention delivery, to assist in tracking, training, and quality control for biological specimen collection, to assist in coordinating and analyzing data for qualitative studies, to assist in materials development, to analyze the study data and to assist in manuscript preparation. In addition, RTI/UNC will provide logistic support for the entire study. This includes setting up conference calls and meetings, taking minutes at these meetings, and distributing study materials. We also will hire on-site data collection coordinators in each country.
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