PROJECT SUMMARY / ABSTRACT: Biostatistics and Data Management Core The Biostatistics and Data Management Core will provide support for the three Main Projects, Pilot Projects and trainees. The Core has a team of experienced biostatisticians and other quantitative experts with a wide diversity of skills, including innovative statistical analysis, REDCAP database design and management, clinical trials monitoring and reporting and bioinformatics. The Core has developed a large infrastructure in the previous funding period (Penn State TCORS; P50 DA036107) and has worked closely with each of the project leaders. The Core will be an integral part of the whole Project. Its members will participate in regular project meetings and will provide timely and high-quality service by welcoming walk-in discussion and by quick turnaround in data analysis (1-3 workdays). The Core Director will also present progress reports at each of the External Advisory Board meetings. The core will take steps to enhance the rigor and reproducibility of the research, using the REDCAP database management system to ensure data accuracy, providing weekly reports of study progress, and ensuring that have a set of clearly defined scientific questions before data collection and analysis begins, using best-practice and transparent statistical methods. Overall, the three Main Projects, Pilot Projects and Career Development activities test hypotheses about tobacco products and their impact on addiction, toxicity and health effects. The biostatistics Core staff have become well versed in tobacco research, have co-authored TCORS publications, and provide advice on statistical approaches as they relate to tobacco-specific issues. They will participate in the Career Enhancement Training Program, including mentoring of students and serving as class instructors in the TCORS-accredited courses. Additionally, they will be statistical consultants to the pilot projects, including providing assistance with power calculations, design issues and statistical analyses of results.