Research Triangle Institute (RTI) proposes to serve as the Data Coordinating Center (DCC) for the NICHD Global Network for Women's and Children's Health Research (GN). The strong, experienced team of scientists who have led the GN DCC for the past 5 years will continue this effort. Responsibilities of the DCC will include (1) coordinating overall study activities;(2) providing biostatistical and data management leadership;(3) participating in study design and protocol development;(4) developing data management systems (DMSs);(5) collaborating in developing study materials (e.g., data forms) and overseeing translation of these materials into appropriate languages;(6) developing and implementing quality control systems;(7) assisting in training Research Unit (RU) personnel in study procedures, including use of the DMSs;(8) developing capacity for research at the RUs by training RU staff in research methodology, data management, and statistical analysis and assisting them in writing DMSs and in publishing study results;(9) continuing to manage study-wide communications and logistics;(10) assisting RUs (if appropriate) in biological specimen collection;(11) organizing and coordinating Steering Committee (SC) and Data and Safety Monitoring Board (DSMB) meetings;(12) producing routine and special reports that meet the needs of the RUs, NICHD, the SC, and the DSMB;and (13) assisting in disseminating results of the GN studies through publication and presentations. All proposed RTI staff have been involved in carrying out the above responsibilities for the GN, including the PI, Tyler Hartwell, Ph.D., and Co-Pis Vijaya Rao, Ph.D., and Elizabeth McClure, M.Ed. Drs. Hartwell and Rao each have over 30 years of experience in leading DCCs for NIH multicenter studies, including international studies. We will use an Internal Management Committee to oversee the DCC operations and assign a DCC Protocol Team to work with GN investigators on each new protocol. We will use the existing IT structures, developed over the past 5 years, to collect and transmit study data to RTI from RU sites continuing in the Network, including hardware, software, and the on-site IT expert and data manager to assist in maintaining the systems. For new RUs, we will assist in purchasing the computer equipment required for data collection, management, and transmission and will help train new RU site staff to manage the systems developed. Our communications network will again be built around conference calls, e-mail, and the project website that disseminates project reports and study materials. During the first year of the project, RTI will collaborate with RU staff and NICHD to finish publications from single site protocols from the first phase of the study, complete data collection on the FIRST BREATH multicenter protocol, and begin developing additional common protocols for randomized clinical trials.
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