Core A: Administrative/Biostatistics Core

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CORE A ABSTRACT Core A, the Program Management and Biostatistics Core, is directed by Multi-PIs Drs. Richard C. Boucher and Michael Rubinstein and will have two major functions: 1) project coordination and administration to achieve PPG goals; and 2) provision of statistical assistance in study design and analysis. Oversight and assistance in guiding the overall scientific direction of the PPG will be provided by an Internal Advisory Board, consisting of: Drs. Richard Superfine, Chair, Department of Applied Sciences at UNC-CH; Dr. Greg Forest, Director, Carolina Center for Interdisciplinary Applied Mathematics at UNC-CH; and Dr. Sam Lai, Director, Pharmacoengineering Program, Division of Pharmacoengineering and Molecular Pharmaceutics at UNC-CH. Due to the nascent status of the PPG, the External Advisory Board will be named later. The program management functions of Core A will include: 1) budgetary and programmatic support; 2) facilitation of human subjects interactions with the relevant IRBs with respect to human materials for airway submucosal gland mucus studies; 3) conflict of interest management, with particular relevance to agents obtained via MTAs; 4) personnel support, interfacing the PPG to the UNC human resources departments; 5) manuscript preparation; 6) progress reports and correspondence with the NHLBI; 7) information handling, including dissemination of all research data in an appropriate and timely fashion; and 8) the coordination of a yearly External Advisory Board meeting. In parallel, biostatistics consultation, design, and analyses will be performed by Ms. Agathe Ceppe, who is a longstanding member of the Marsico Lung Institute as a provider of statistical services. Finally, the Program Management and Biostatistics Core will oversee all issues of PD/PI replacement designations, including those that may be relevant to the directorship of the PPG, individual projects, or individual cores.