Research Triangle Institute (RTI) proposes to continue serving as the Data Coordinating Center (DCC) for the Cooperative Multicenter Neonatal Research Network (NRN). The senior staff proposed for this continued effort are the same as those who have directed the DCC for the last 4 years. In addition, they have directed other data coordinating centers for 30 years and have completed or are now conducting seven major studies in maternal/perinatal/neonatal research. Current studies are three networks, including the currently proposed one, that conduct multisite, multiprotocol studies in neonatology and maternal and child health. Dr. W. Kenneth Poole, the proposed Principal Investigator (PI), has been the PI or Co-PI of 12 major DCC projects. In particular, he is the current PI of the DCC for the NRN, is a protocol statistician for the Global Network for Women's and Children's Health Research, has been the PI of the High Frequency Ventilation (HIFI) and Respiratory Distress Syndrome (RDS) studies, was Co-PI of the Vaginal Infection & Prematurity (VIP) study, and was senior statistician on NICHD's Study of Early Child Care (SECC) and DC Initiative studies. Also, Dr. Poole and some of our proposed staff worked with four of the current Network PIs on the HIFI and RDS studies prior to taking over the DCC for the NRN. All of our proposed staff have worked together for many years on DCC projects including the studies in maternal/perinatal/neonatal research. RTI has Rockville, MD offices next door to NICHD. A coordinator, a senior analyst, three statisticians (including the Co-PI), and a support person are located in this Rockville facility. RTI assumes a leadership role for the Network in the areas of statistical design and analysis, data collection procedures, data management and processing, quality control, randomization, study logistics, Network communications, and tracking drug supplies and specimens. We use state-of-the-art methods of data collection, processing, and management, including computer-assisted data collection methods, electronic data transfer, a web site, and Internet linkages with the study collaborators. RTI's matrix management structure, whereby individual staff may be assigned to several projects, provides considerable flexibility in allocating additional resources to projects at times of peak needs. Institute staff have an impressive track record working with site PIs and statisticians in the development of manuscripts for publication.
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