Biostatistics, Bioinformatics and Environmental Sampling Core

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Abstract The Biostatistics, Bioinformatics and Exposure Sampling (BBES) Core will provide an integrated approach to all projects with regard to 1) study design, 2) inhalation exposure assessment tools and measurement, 3) integration and management of phenotype, inhalation exposure and molecular data, and 4) biostatistical and bioinformatics analysis. By centralizing these activities, we expect that this multidisciplinary Core will increase the level of interaction among the projects and between projects and the Core. This strategy will allow us to coordinate study design and data management issues, leading to a more coherent approach to exposure assessment and data analysis as well as significant cost savings. The Core Director (Fingerlin) along with the inhalation exposure assessment lead (Thornburg) will supervise a team that is experienced in the conduct of studies involving the coordination of multidisciplinary teams in research. The team has the skill set required to manage complex issues of study design, epidemiology, genomics, broad quantitative methods, data management and inhalation exposure assessment. Interaction with Projects and Cores: The BBES Core will serve all four projects. Projects will receive assistance with Study Design from the Core including consultation with project PIs on methodological issues, at the initiation of a study, and ongoing consultation as the study progresses. Under the direction of Dr. Thornburg, the Inhalation Exposure Assessment responsibilities of the Core will be to 1) provide personal exposure monitors to Project 1, and 2) quantify exposures based on the filters taken from the personal monitors that will be utilized by all projects and 3) maintain comprehensive exposure data sets and transfer these data to NJH. The Core's Data Integration and Management responsibilities will serve all projects as well as the Administrative Core including: 1) management of data acquisition and transfer, 2) development and maintenance of research databases, and 3) ensuring data backup, storage, and security. The Core's Biostatistical and Bioinformatics Analysis responsibilities will include: 1) meeting with Project Directors to determine analysis needs, 2) conducting the biostatistical analyses, and 3) conducting bioinformatic analyses to summarize and interrogate the biostatistical results in terms of biologic pathways. Each project will benefit from the services provided to the other projects; the same experts will work on all three projects, which will ensure cross-fertilization of ideas and sharing of information. In addition, The BBES Core will interact closely with the Clinical Core to coordinate both exposure assessment and capture of clinical phenotype data. Finally, this Core will coordinate with the Administrative Core, as it provides the administrative and organizational structure to support this Program, and will receive direction from the Administrative Core and the Executive Committee. This Core will interact with the Administrative Core at monthly meetings with Project Leaders, and provide reports on its activities as needed otherwise. Members of the Core will attend the monthly Program meetings and will have individual monthly meetings with each project; these meetings will be staggered such that each week Dr. Fingerlin and appropriate Core investigators will meet with either an individual Project team or the entire Program. The products from the Core to the Program include 1) data integration and analysis scripts, comprehensive de- identified data sets, exposure monitor data, data analysis summaries with documentation, and participation in all aspects of dissemination. These products will assist all of the Projects and the Administrative Core in fulfilling their research, reporting and resource sharing goals and obligations.