Administrative Core

项目摘要。烟草产品研究中心(CSTP)的目标是在以前的基础上 通过转向影响分析的综合主题，成功地开展了烟草产品评价工作。这个 这一努力的基本原理是，它将提供一个跨学科的模型，利用该模型，来自几个 域名可以帮助FDA预测潜在的烟草产品监管可能满足的程度 强制性的《公共卫生标准》。CSTP的愿景是提供可用于指导监管的工具 开发，以便在法规生效时，已使用经过验证的方法对其进行测试， 提炼它，并生成数据显示其促进健康的效果最大化，任何有害的， 意想不到的后果被降至最低。为了实现这一愿景，CSTP建立在现有的 来自多个学科的科学家和教育工作者进行假设驱动的研究和测试总体- 水平预测。一个具有复杂协作和跨学科研究愿景的中心需要强大的 行政结构来支持它。因此，行政核心的具体目标是：(1)促进 财务和管理程序；(2)建立评价进展的机制；(3)促进内部、内部、 和中心外合作，(4)将结果传播给FDA、NIH和其他科学家和政策制定者(5) 提供集中招聘、数据管理、生物统计和参与者保护支持，以及(6) 快速响应监管需求。总括而言，行政核心会继续服务和加强 CSTP通过减轻管理负担；跟踪项目和中心成功的基准；集成 将调查人员、被任命者和非中心科学家纳入国家技术合作方案的活动；确保将知识转移到 公共、科学和决策社区；提供招聘支持和生物统计专业知识； 并对FDA的需求做出快速反应。管理核心由一个在以下领域拥有良好业绩记录的团队领导 跨学科协作、项目管理、报告、沟通和传播。

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.