Administrative Core

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Project Summary. The Center for the Study of Tobacco Products (CSTP) aims to build upon previous successful work on tobacco product evaluation by moving to an integrative theme of impact analysis. The rationale for this effort is that it will provide a transdisciplinary model with which empirical data from several domains can help FDA to predict the extent to which potential tobacco product regulation is likely to meet the mandated “public health standard”. The CSTP’s vision is to provide tools that can be used to guide regulation development so that, by the time a regulation goes into effect, validated methods have been used to test it, refine it, and generate data showing that its health-promoting effects are maximized and that any harmful, unintended consequences are minimized. To realize this vision, the CSTP builds on an existing team of scientists and educators from multiple disciplines to conduct hypothesis-driven research and test population- level predictions. A Center with a complex collaborative and transdisciplinary research vision requires a strong administrative structure to support it. Thus, the specific aims of the Administrative Core are to: (1) facilitate financial and managerial processes, (2) establish mechanisms for evaluation of progress (3) foster intra-, inter-, and extra-Center collaboration, (4) disseminate results to FDA, NIH, and other scientists and policymakers (5) provide centralized recruitment, data management, biostatistical, and participant protections support, and (6) respond rapidly to regulatory needs. In sum, the Administrative Core will continue to serve and strengthen the CSTP by reducing management burden; tracking benchmarks of project and Center success; integrating investigators, appointees, and non-center scientists into CSTP activities; ensuring knowledge transfer to the public, scientific, and decision-making communities; providing recruitment support and biostatistical expertise; and responding rapidly to FDA needs. The Administrative Core is led by a team with a proven track record in transdisciplinary collaboration, project management, reporting, communication and dissemination.