Administrative Core

行政核心

• 批准号: 10665899
• 负责人: JOSHUA E MUSCAT
• 金额: $ 37.01万
• 依托单位: PENNSYLVANIA STATE UNIV HERSHEY MED CTR
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-30 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10665899
• 关键词: Adverse event; Advertising; Animal Experimentation; Authorization documentation; Clinical Trials Data Monitoring Committees; Collaborations; Communication; Communities; Development; Doctor of Philosophy; Electronics; Ensure; Environment; Ethics; Faculty; Feedback; Funding; Funding Opportunities; Future; Goals; Government; Grant; Health; Health Sciences; Human Resources; Infrastructure; Institution; Laboratories; Laws; Leadership; Legal; Medicine; Mission; Monitor; Muscat; Parents; Peer Review; Pharmacology; Pilot Projects; Policies; Positioning Attribute; Printing; Procedures; Productivity; Psychiatry; Public Health; Quality Control; Recommendation; Reporting; Research; Research Personnel; Resource Allocation; Resources; Science; Scientist; Secure; Structure; Tobacco; Toxic effect; Training; Training Programs; United States National Institutes of Health; Universities; University of Texas M D Anderson Cancer Center; Work; addiction; authority; career; career development; college; data management; expectation; experience; good laboratory practice; human subject; meetings; member; next generation; operation; professor; recruit; response; success; symposium; timeline; tobacco control; tobacco products; tobacco regulatory science; webinar; working group

PROJECT SUMMARY / ABSTRACT: Administrative Core The goal of the Administrative Core is to promote an environment of communication and collaboration among Penn State TCORS investigators, across TCORS, and with CASEL and FDA and NIH staff. To accomplish this, the Core will work closely with our TCORS components to establish the governance procedures, prioritization, interaction, feedback and communication within the TCORS including its affiliate University of Texas MD Anderson Cancer Center. The Administrative Core will oversee the fiduciary, ethical and legal responsibilities of the TCORS and its members. The Core will manage and assume responsibility for responding to the prioritizations of the FDA, NIH and the TCORS funding opportunity announcement. This includes the conduct of scientific studies within the scientific domains of the RFA, forming an External Advisory Board (EAB) and arranging for annual meetings with NIH officials and the EAB. The Core will assume the responsibility for the Center’s rapid response capability, and adhering to recommendations and requests from the EAB, the Internal Advisory Board, CASEL, national TCORS working groups and initiatives. The Administrative Core will work to be at the forefront of FDA tobacco regulatory law, utilizing its EAB and Admin Core experts in regulatory law and tobacco regulatory science to guide our activities. The Core will encourage TCORS members to assume leadership positions in the national TCORS initiatives on working groups, webinars and other venues. The TCORS will be supported by the Penn State College of Medicine Center for Research on Tobacco and Health, which facilitates and coordinates tobacco research across the Departments and Graduate training programs in the College of Medicine The Steering Committee includes faculty members who have collaborated for many years on tobacco control and interdisciplinary tobacco research. The Steering Committee will meet at least weekly to insure that the Center adheres to state of-the-art science, its integrative theme, and make recommendations for changes in direction if necessary. The Core will insure that all activities, including career development, pilot projects, major projects, and collaboration with other TCORS are responsive to FDA regulatory needs and its authority. Based on the Penn State TCORS (2014-2019), which included many of the same PIs and Co-Is, we have had significant experience in the administration of a TCORS both locally and nationally. A key component of the Core is overseeing the Career Enhancement and Training Core. Our previous TCORS had over 20 trainees, many of which have received their own funding including NIH training grants, are now fully employed at the FDA Center for Tobacco Products, or have attained faculty positions at Penn State or elsewhere. The Career Enhancement Training Program is led by two former trainees, who are now faculty, and well positioned to continue the training and career development of the next generation of tobacco regulatory scientists.

项目摘要 /摘要：行政核心 行政核心的目的是促进沟通和协作的环境 在宾夕法尼亚州TCORS调查人员中，遍布TCOR，以及Casel和FDA和NIH的工作人员。到 这样做，核心将与我们的TCORS组件紧密合作以建立治理 TCOR内的程序，优先级，互动，反馈和沟通，包括其会员 德克萨斯大学医学博士安德森癌症中心。行政核心将监督信托，道德 TCOR及其成员的法律责任。核心将管理并承担 回应FDA，NIH和TCORS资助机会公告的先验性炎。这 包括在RFA科学领域内的科学研究的行为，形成外部咨询 董事会（EAB）并安排与NIH官员和EAB的年度会议。核心将假设 对中心快速响应能力的责任，并遵守建议和要求 EAB，内部顾问委员会，CASEL，国家TCORS工作组和计划。这 行政核心将使用其EAB和Admin处于FDA烟草监管法的最前沿 监管法和烟草监管科学方面的核心专家指导我们的活动。核心将鼓励 TCORS成员在国家TCOR的工作组中担任领导职务， 网络研讨会和其他场所。 TCOR将得到宾夕法尼亚州立医学中心的支持 研究烟草和健康的研究，这些部门的设施和协调烟草研究 和医学院的研究生培训课程 指导委员会包括在烟草上合作多年的教职员工 控制和跨学科烟草研究。指导委员会将至少每周开会，以确保 该中心遵守最先进的科学，其综合主题，并为更改提出建议 如有必要，在方向上。核心将确保所有活动，包括职业发展，飞行员项目， 主要项目和与其他TCOR的合作对FDA监管需求及其权威有响应。 基于宾夕法尼亚州立大学（Penn State TCORS）（2014-2019），其中包括许多相同的PI和CO-IS，我们已经 在本地和全国范围内管理TCOR的重要经验。一个关键组成部分 核心正在监督职业增强和训练核心。我们以前的TCOR有20多名学员， 其中许多已经获得了自己的资金，包括NIH培训补助金，现在已完全在 FDA烟草产品中心，或在宾夕法尼亚州或其他地方担任教师职位。职业 增强培训计划由两个以前的培训领导，他们现在是教职 继续下一代烟草监管科学家的培训和职业发展。