RTI International proposes to continue serving as the Data Coordinating Center (DCC) for the Cooperative Multicenter Neonatal Research Network (NRN), for which we have been the DCC since 1998. Our experienced team proposes to continue its collaboration with the NRN investigators in (1) developing and implementing research protocols, (2) disseminating study results, (3) providing leadership in statistical design and analysis, (4) providing data management, and (5) providing logistical support. Dr. Abhik Das, the proposed PI for this study, has led the NRN DCC since 2003 as co-Pi and PI, and has been a statistician with the NRN since 1999. He has also served as a Senior Statistician for the Global Network for Women's and Children's Health Research DCC and Protocol Director for an NIH-DC Initiative study DCC. Other proposed senior staff, including the Alternate PI Dr. W. Kenneth Poole, has worked on the NRN DCC since 1998, and all of our proposed staff has worked together for many years on multisite collaborative studies in maternal/perinatal/neonatal research. While proud of our past accomplishments as the DCC for the NRN, our goal in continuing as the NRN DCC is to continually adapt and seek opportunities to evolve as research needs and technologies change. In this application, we thus propose to use innovative statistical approaches including newer clinical trial designs appropriate for neonatal research. We also propose to use a flexible organizational structure to (1) organize staff into protocol teams supporting each protocol, (2) designate one person to manage all regulatory compliance and quality control issues, and (3) identify a pool of experts who can support specialized studies as needed. We will continue to improve our existing Data Management System (DMS), developed over the past 9 years, to collect, transmit, and manage study data. We will implement FDA IND protocols using appropriate validated data systems, standardized processes for QA and regulatory compliance, and adequate clinical monitoring regimes. This application offers specific strengths that can help advance the NRN research agenda, including: (1) a highly qualified and motivated staff with years of experience with NRN data and in-depth knowledge of current and planned NRN protocols, who can transition seamlessly into the new DCC funding period without additional training, (2) a state-of-the-art DMS that is flexible and has been customized to meet the needs of the NRN, incorporating broadband data transmission, intra- and cross-form edits, automated reports, and randomization systems, (3) a proven track record of collaboration in publications on NRN research findings in peer-reviewed journals, (4) an administrative structure providing maximum flexibility in staffing projects to fully maximize personnel resources and respond quickly to changing NRN needs, and (5) offices in Rockville, MD, that house the proposed PI and are adjacent to the NICHD.
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