REGULATORY CORE

监管核心

• 批准号: 8359867
• 负责人: Mayer Benson Davidson
• 金额: $ 3.64万
• 依托单位: CHARLES R. DREW UNIVERSITY OF MED & SCI
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-07-01 至 2012-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8359867
• 关键词: Academia; Animal Experimentation; Area; Authorship; Biometry; Clinical; Clinical Research; Collaborations; Communication; Communities; Conflict of Interest; Consultations; Development; Discipline; Effectiveness; Ethics; Faculty; Frustration; Funding; Grant; Health; Healthcare; Home environment; Housing; Human; IACUC; Infectious Agent; Institution; Institutional Review Boards; Interdisciplinary Study; Knowledge; Laboratories; Location; Medical; Medicine; Minority; Monitor; National Center for Research Resources; Participant; Patients; Performance; Pilot Projects; Policies; Population; Principal Investigator; Process; Recombinant DNA; Recommendation; Research; Research Design; Research Infrastructure; Research Methodology; Research Personnel; Research Subjects; Resources; Rights; Science; Services; Site; Social Welfare; Solutions; Source; Strategic Planning; Structure; System; Technology; Toxin; Training; Training Activity; Training and Education; Translational Research; Translations; Underserved Population; United States National Institutes of Health; United States Office of Research Integrity; Universities; Vision; Vulnerable Populations; biomedical informatics; career development; catalyst; cost; cost effective; design; experience; improved; innovation; institutional biosafety committee; multidisciplinary; programs; quality assurance; virtual; web site

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. Primary support for the subproject and the subproject's principal investigator may have been provided by other sources, including other NIH sources. The Total Cost listed for the subproject likely represents the estimated amount of Center infrastructure utilized by the subproject, not direct funding provided by the NCRR grant to the subproject or subproject staff. REGULATORY KNOWLEDGE, ETHICS, AND SUPPORT FUNCTION APPLICATION OVERVIEW The Accelerating eXcellence In translational Science (AXIS) will be the catalyst to implement the CDU Research Strategic Plan and will become the integrated home for clinical and translational research. The structure of the CDU AXIS includes an innovative and proactive governance structure, the AXIS Concierge Desk, and nine key functions/activities. The Concierge Desk (clinical and translational research infrastructure) will be a physical and virtual (Web site) hub that will bring all research services together by providing consultation, training and education, and community engagement resources offered throughout the functions. The Collaborations and Partnerships Function will provide resources, locations, research, and other activities that will draw community and academia together to explore cross communication and partnerships. The Multidisciplinary Training and Career Development Function will streamline and centralize all faculty development activities across the University. The Community Engagement and Research Function is a formal mechanism to organize community resources and integrate community into the educational process at CDU in order to bring community expertise to interdisciplinary research teams. The Research Design and Biostatistics Function will provide consultation and training activities in research design and biostatistics. The Participant and Clinical Interactions Resources Function will integrate a system to make resources and expertise in design and biostatistics more readily available across the University to support investigators engaged in translational research and will represent an upgrade in functionality of the Clinical Research Center. The Regulatory Knowledge, Ethics, and Support Function will provide direct support, assistance, and consultation to research facilitators and researchers; share best practices; and develop innovative programs. The Biomedical Informatics Function proposes to enhance and expand the support services, making them available to all investigators and faculty across all disciplines to boost the effectiveness of implementation of knowledge into medical policy and practice. The Technology and Resources for Core Laboratories Function proposes to realign the support services and resources for investigators across all CDU disciplines and among collaborating institutions in an effort to enhance the quality of science. The Pilot Project Program describes the plan to solicit proposals, prioritize projects, and review methodologies and research performance.

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。对子项目和子项目主要研究者的主要支持可能是由其他来源提供的，包括其他 NIH 来源。 子项目列出的总成本可能代表子项目使用的中心基础设施的估计金额，而不是 NCRR 拨款向子项目或子项目工作人员提供的直接资金。 监管知识、道德和支持职能应用概述 转化科学加速卓越计划 (AXIS) 将成为实施 CDU 研究战略计划的催化剂，并将成为临床和转化研究的综合家园。 CDU AXIS 的结构包括创新且积极主动的治理结构、AXIS 礼宾服务台和九项关键职能/活动。礼宾服务台（临床和转化研究基础设施）将成为一个物理和虚拟（网站）中心，通过提供咨询、培训和教育以及整个职能部门提供的社区参与资源，将所有研究服务汇集在一起​​。 合作与伙伴关系职能将提供资源、地点、研究和其他活动，吸引社区和学术界共同探索交叉沟通和伙伴关系。 多学科培训和职业发展职能将简化和集中整个大学的所有教师发展活动。社区参与和研究职能是组织社区资源并将社区融入基民盟教育过程的正式机制，以便为跨学科研究团队带来社区专业知识。研究设计和生物统计学职能将提供研究设计和生物统计学方面的咨询和培训活动。参与者和临床互动资源功能将整合一个系统，使整个大学更容易获得设计和生物统计学方面的资源和专业知识，以支持从事转化研究的研究人员，并将代表临床研究中心功能的升级。监管知识、道德和支持职能将提供直接支持、协助、 以及向研究促进者和研究人员提供咨询；分享最佳实践；并制定创新计划。生物医学信息学职能建议加强和扩大支持服务，使所有学科的所有研究人员和教员都可以使用这些服务，以提高将知识落实到医疗政策和实践中的有效性。核心实验室职能的技术和资源建议重新调整为所有研究人员提供的支持服务和资源 CDU 学科和合作机构之间致力于提高科学质量。试点项目计划描述了征求建议、确定项目优先顺序以及审查方法和研究绩效的计划。