Administrative Core

行政核心

基本信息

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
项目类别：
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

项目摘要

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标是促进沟通和协作的环境宾夕法尼亚州立大学 TCORS 研究人员、整个 TCORS 以及 CASEL、FDA 和 NIH 工作人员。为了实现这一目标，核心将与我们的 TCORS 组件密切合作来建立治理 TCORS（包括其附属机构）内的程序、优先级、互动、反馈和沟通德克萨斯大学 MD 安德森癌症中心的行政核心将监督信托、道德。 TCORS 及其成员的法律责任将由核心管理并承担责任。响应 FDA、NIH 和 TCORS 资助机会公告的优先顺序。包括在 RFA 科学领域内进行科学研究，形成外部咨询委员会 (EAB) 并安排与 NIH 官员的年度会议，而 EAB 则由核心承担。对中心的快速反应能力负责，并遵守来自各方的建议和要求 EAB、内部咨询委员会、CASEL、国家 TCORS 工作组和倡议。行政核心将利用其 EAB 和 Admin 致力于走在 FDA 烟草监管法的最前沿监管法和烟草监管科学领域的核心专家将鼓励我们的活动。 TCORS 成员将在国家 TCORS 倡议工作组中担任领导职务， TCORS 将得到宾夕法尼亚州立大学医学院中心的支持。烟草与健康研究，促进和协调各部门的烟草研究和医学院的研究生培训计划指导委员会包括在烟草领域合作多年的教职人员指导委员会将至少每周举行一次会议，以确保控制和跨学科烟草研究。该中心坚持最先进的科学及其综合主题，并提出变革建议如有必要，核心将确保所有活动，包括职业发展、试点项目，主要项目以及与其他 TCORS 的合作均响应 FDA 的监管需求及其权威。根据宾夕法尼亚州立大学 TCORS（2014-2019 年）（其中包括许多相同的 PI 和 Co-Is），我们有在本地和国家层面管理 TCORS 方面拥有丰富的经验，是 TCORS 的重要组成部分。 Core 负责监督职业提升和培训核心。我们之前的 TCORS 有 20 多名学员。其中许多人获得了自己的资金，包括 NIH 培训补助金，现在已在该机构充分就业 FDA 烟草产品中心，或已在宾夕法尼亚州立大学或其他地方获得教职。增强培训计划由两名前学员领导，他们现在是教员，并且有能力继续下一代烟草监管科学家的培训和职业发展。