CPEA Data Coordinating Center

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DESCRIPTION (provided by applicant): Since 1997, the National Institute of Child Health and Human Development (NICHD) and the National Institute on Deafness and Other Communication Disorders (NIDCD) has provided funding for a Network on the Neurobiology and Genetics of Autism: Collaborative Programs of Excellence in Autism (CPEA). The CPEA network of 10 multidisciplinary projects is being extended for an additional five years to continue studies of genes, brain structure, brain function and behavior and the clinical course of autism. Three separate entities (DMSTAT, Inc., the Boston University Statistics and Consulting Unit at the College of Arts and Sciences and the Department of Biostatistics at the Boston University School of Public Health) have formed a group, DMSTAT/BU, proposing to collaborate with the CPEA network and to serve as its centralized data coordinating center (DCC). Our multi-disciplinary team of biostatisticians, epidemiologists, statistical geneticists, project managers, programmers and data managers can effectively and efficiently serve the ongoing and changing needs of the CPEA network. The primary goal of DMSTAT/BU is to provide integrated support to all CPEA project staff on two fronts: 1) consistent, efficient, cost-effective and high quality data management, and 2) biostatistical expertise in study design, randomization schemes, matching procedures, statistical genetics and multivariable analysis. DMSTAT/BU will assist project staff in the following areas: study design and protocol development, innovative processes to streamline data collection and increase data quality, administrative management, staff training, study monitoring, regulatory compliance, statistical design, analysis and reporting, and study documentation, in addition to applying our proven data management and statistical analysis procedures, DMSTAT/BU will develop a website for the network which will serve as the backbone of the study infrastructure. The website will have administrative (e.g., e-mail links, meeting information, personnel contact information, project documentation, expense tracking) and data collection (distributed tracking and data entry systems) components. A reporting module in the website will make all of the administrative and data management information accessible to authorized members of the CPEA network. The team we have assembled has the requisite experience to effectively serve the needs of the CPEA network. The qualities that set us apart from our competitors are: innovation in streamlining and organizing processes, our abilities to educate and communicate with study staff at all levels, the breadth and depth of our analytic and statistical knowledge, our commitment to integrity in all aspects of data management, and our outstanding track record on studies of similar size and scope.