Core C: Data Management and Statistics Core p293-309

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The Data Management & Statistical Core, "Data Core C", will be a key element serving the FDA CTP by ensuring the integrity of data collection, storage, and transfer among the Research Projects, Cores, and the Developmental/Pilot Research Projects. The overarching goal of the Data Core C is to cost-effectively support the Center research by producing the highest quality data and applying state-of-the-art data analysis and statistical expertise to inform tobacco product regulation. Specifically, it provides the Center investigators with support for procedural consistency and data quality control, data management, database design and development, biostatistical expertise for study design and data analysis, bioinformatics support, and data interpretation and reporting. The Co-Directors, Dr. Lee, UMCP Biostatistics and Risk Analysis Center (BRAC), and Dr. Varshney, UMCP Institute for Advanced Computer Sciences, have experience successfully managing large teams of statisticians and database managers to support multiple, simultaneously-ongoing public health research projects. Data Core C will also play an important role in developing the proposals for the Developmental/Pilot and time-sensitive research component by providing post-doctoral students in Training Core D and other investigators with cost effective statistical resources and support for data analysis in individual research projects. Examples of services include statistical consultation and guidance on issues such as study design, sample size calculations, data analysis plans, statistical analysis techniques, and interpretation and reporting of results. The Core will design, develop, populate, and administer an interactive, secure, privilege-based database that will house all Center data, including subject recruitment, questionnaire and demographic data, HPHC exposure and biomarker levels, tobacco product HPHC emissions and content levels, EEG measures associated with product acceptability, and bacterial metagenome data. All data will undergo a consistent, rigorous cleaning protocol, conducted by the Core in close collaboration with the Research Project PI, prior to approved entry into the Center database.