Administrative Core

行政核心

基本信息

批准号：
10666239
负责人：
SUCHITRA KRISHNAN-SARIN
金额：
$ 85.33万
依托单位：
YALE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-09-30 至 2028-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10666239
关键词：
Address Adherence Advertising Age Annual Reports Budgets Clinical Trials Clinical Trials Data Monitoring Committees Collaborations Communication Communities Consultations Data Data Analyses Data Collection Data Set Eligibility Determination Ensure Ethnic Origin IACUC Institutional Review Boards Interdisciplinary Study Medical Monitor National Institute of Drug Abuse Nicotine Organizational Affiliation Participant Patient Recruitments Population Press Releases Productivity Protocols documentation Public Health Publications Quality Control Race Regulation Reporting Research Research Personnel Research Training Resolution Resources Role Running Safety Sarin Schools Science Services Source Structure Tobacco Tobacco use Training United States National Institutes of Health addiction data integrity data management data sharing design innovation member participant retention recruit screening sex success syntax tobacco products tobacco regulation tobacco regulatory science

项目摘要

ABSTRACT: ADMINISTRATIVE CORE The success of the Yale Center for the Study of Tobacco Products (YCSTP) requires coordinated efforts at many levels. In a role similar to its function for TCORS 1.0 and 2.0, the Administrative Core will provide the centralized oversight required to effectively and efficiently run the Center’s primary Projects and pilots. The Administrative Core also will ensure productive collaboration both within the YCSTP and with external partners including the FDA, the TCORS Coordinating Center, and other TCORS. To carry out its duties, the Administrative Core has five specific aims: 1) to provide scientific oversight and monitoring of YCSTP activities internally via the YCSTP Executive Committee (Project/Core Leads and NIDA/CTP liaisons) and in consultation with our center’s Data Safety and Monitoring Board, Scientific Advisory Board, and Community Advisory Board, 2) to manage Center activities related to progress through coordinating timely training of research staff on central study assessments as well as participant recruitment and retention, monitoring safety, and submitting biannual reports on the progress of all projects, 3) to manage and share data by creating and maintaining datasets for internal use and preparing limited and/or public datasets for external use, 4) to provide oversight of regulatory, fiscal, and dissemination activities to ensure that YCSTP resources are used appropriately and efficiently and that findings are disseminated through a variety of sources including docket submissions, press releases, academic presentations and publications, and presentations within the community, and 5) to facilitate communication and collaboration within the Center and with NIH, FDA, the Coordinating Center, and other TCORS. Overall, the activities of the Administrative Core are essential to supporting the timely completion of the proposed research and providing the FDA-CTP with the evidence required to support the regulation of tobacco products. As in TCORS 1.0 and 2.0, the Administrative Core will be led by the PIs for the YCSTP, Drs. Suchitra Krishnan-Sarin and Stephanie O’Malley.

摘要：管理核心耶鲁大学烟草产品研究中心（YCSTP）的成功需要协调的努力许多级别。在与TCORS 1.0和2.0功能类似的角色中，管理核心将提供需要有效，有效地运行该中心的主要项目和飞行员所需的集中监督。行政核心还将确保YCSTP内部和外部的富有成效的合作包括FDA，TCORS协调中心和其他TCOR在内的合作伙伴。为了履行职责，行政核心具有五个具体目标：1）提供科学监督和监视YCSTP活动内部通过YCSTP执行委员会（项目/核心领导和NIDA/CTP联络）以及与我们中心的数据安全和监测委员会，科学咨询委员会和社区咨询顾问委员会，2）管理与进展有关的中心活动，及时培训中央研究评估的研究人员以及参与者的招聘和保留，监控安全性，并提交有关所有项目进度的双年度报告，3）通过创建和来管理和共享数据维护用于内部使用和准备有限和/或公共数据集的数据集，以供外部使用，4）提供监督监管，财政和传播活动，以确保使用YCSTP资源适当有效地，发现通过包括Docket在内的各种来源传播发现提交，新闻稿，学术演讲和出版物以及介绍社区，以及5）促进中心内以及与NIH，FDA的沟通和协作协调中心和其他TCOR。总体而言，行政核心的活动对于支持及时完成拟议的研究并为FDA-CTP提供证据支持烟草产品的调节。与TCORS 1.0和2.0一样，行政核心将由YCSTP的PI领导。 Suchitra Krishnan-Sarin和Stephanie O'Malley。