RTI International (RTI), a trade name for Research Triangle Institute, proposes to become the Data Coordinating and Analysis Center (DCAC) for NICHD's """"""""Research on the Scope and Causes of Stillbirth in the United States"""""""" network. RTrs twenty-nine years of experience serving as DCAC for a vadety of multisite clinical and behavioral studies, many in the field of maternal and child health, enable us to recognize the various responsibilities that must be undertaken by a DCAC to successfully meet the ever changing needs of a multisite study. These responsibilities include, but are not limited to: (1) participating in protocol development, (2) developing and implementing a study-wide communications network, (3) providing sophisticated data collection and management systems that are responsive to the emerging needs of the study, (4) supporting the logistics of the study as needed, (5) assisting in training site personnel in standard study procedures, (6) assisting in developing and implementing quality control and quality assurance procedures, (7) providing biostatistical and data management leadership, (8) producing both routine and ad hoc reports that meet the needs of the Clinical Sites, NICHD, the Steering Committee, the Advisory Committee and the Data Safety and Monitoring Committee, and (9) helping to disseminate the results of the study through publications and presentations. The key staff proposed for the project, Dr. Corette Parker, PI, and Dr. Matthew Koch, Co-PI, are both senior biostatisticians with supporting programs in epidemiology. They each have over 15 years experience managing DCAC activities and leading statistical tasks for multisite studies. Dr. Koch's medical degree provides an additional badge between the statistical and medical components of the network. As the demands of the network change, we will be able to supplement our base staff with needed expertise from our large staff with vaded backgrounds that address the anticipated needs of the study. RTI' office next door to NICHD in Rockville, MD provides meeting space as needed for interaction with NICHD staff. During the first year of the project, RTI will collaborate with NICHD and the Steering Committee to develop the study protocol with particular input into statistical design and analysis, data capture methods, data management and processing, quality control, and training of site data collection and data management staff.
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