Administrative Core

行政核心

• 批准号: 10271645
• 负责人: David Alland
• 金额: $ 13.69万
• 依托单位: RBHS-NEW JERSEY MEDICAL SCHOOL
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-23 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10271645
• 关键词: Animals; Award; Biological Specimen Banks; Blood specimen; Brazil; Clinical; Clinical Data; Clinical Protocols; Clinical Research; Collaborations; Collection; Communication; Data; Genomics; Heterogeneity; Infrastructure; Lead; Logistics; Monitor; Online Systems; Policies; Principal Investigator; Procedures; Progress Reports; Protocols documentation; Public Health; Research; Research Personnel; Resolution; Resources; Site; Specimen; Structure; System; Systems Biology; Training; Uganda; United States National Institutes of Health; Validation; Work; data centers; data management; data structure; emerging pathogen; experience; human subject; international center; meetings; operation; programs; research and development

TBRU Administrative Core (Admin Core) The proposed TBRU application will be supported by an Administrative Core structure to assist, coordinate and maintain the TB Research Unit, the unit's research and development progress, communications, interactions with internal and external partners and provide problem resolution. The Admin Core and Data Center will sit physically within a dedicated suite and share infrastructure and facilities developed for TB research in the International Center for Public Health (ICPH) building on the Rutgers-NJMS campus. Core lead is Dr. Alland, with Co-Leads - Mr. David Hom and Ms. Francesca Escaleira. Specific Aims: 1. Develop and operate an administrative (fiscal, regulatory), operational (scientific, logistics) infrastructure and data management center capable of supporting proposed clinical, animal & translational protocols. 2. Maintain fiscal compliance and site reimbursement procedures per NIH policy. 3. Communicate and work with NIH program staff to monitor study progress and achieve milestones. 4. Coordinate and collaborate with other TBRU programs to leverage expertise across network. A Management Plan and system will be deployed to maintain the operations of the TBRU, including the financial, administrative/regulatory compliance activities, communications within the Unit, its committees and with TBRU-N, programmatic DMID and TBRU meetings, sponsor interactions, progress reports, supplement submissions, and assist Principal Investigators with project assessments. Appropriate and experienced financial analyst, administrative coordinator are available for program conduct and post-awards management. An existing Data Center - Data and Operations Management Center (DOMC) in the Center for Emerging Pathogens (directed by Dr. David Alland) will provide a comprehensive Data Management Plan with appropriate systems to organize, coordinate and validate the collection of clinical data, specimens (MTB strains and blood samples) from the proposed clinical protocols. The DOMC houses trained, experienced staff, who have worked in Uganda and Brazil in clinical studies. Validation and management of data collected will be maintained by the Data Center, monitored by the Clinical Core. A specimen repository system (FreezerPro web-based platform) will be maintained for collected MTB strains and blood samples (described in Clinical Core). The DOMC will also assist with the collection of basic and translational data from TBRU investigators to help with data management and structure required by the Systems Biology Core for statistical, genomic, and systems biology analytic approaches.

TBRU管理核心（Admin Core） 拟议的TBRU应用程序将得到一个行政核心结构的支持， 并维护结核病研究单位、单位的研发进度、沟通、互动 与内部和外部合作伙伴合作，并提供问题解决方案。管理核心和数据中心将位于 物理上在一个专门的套房内，并共享为结核病研究开发的基础设施和设施， 国际公共卫生中心（ICPH）位于Rutgers-NJMS校园内。核心负责人是艾兰医生 与共同牵头人-大卫先生和弗朗西斯卡·埃斯卡雷拉女士。 具体目标： 1.开发和运营行政（财政、监管）、业务（科学、物流）基础设施 和数据管理中心，能够支持拟定的临床、动物和转化方案。 2.根据NIH政策维护财务合规性和研究中心报销程序。 3.与NIH项目人员沟通并合作，以监测研究进展并实现里程碑。 4.与其他TBRU计划协调和合作，以利用整个网络的专业知识。 将部署管理计划和系统，以维持TBRU的运作，包括 财务、行政/监管合规活动，该股内部的沟通，其委员会， 与TBRU-N、计划DMID和TBRU会议、赞助商互动、进度报告、补充 提交，并协助主要研究者进行项目评估。合适且经验丰富 财务分析师，行政协调员可用于项目实施和授标后管理。 现有数据中心-新兴中心的数据和运营管理中心（DOMC） Pathogens（由大卫Alland博士指导）将提供全面的数据管理计划， 组织、协调和验证临床数据、标本（MTB）收集的适当系统 菌株和血液样品）。DOMC的房子训练有素，经验丰富， 工作人员，谁曾在乌干达和巴西的临床研究。所收集数据的验证和管理 将由数据中心维护，并由临床中心进行监测。一种标本库系统， （FreezerPro基于网络的平台）将被维护用于收集的MTB菌株和血液样品（描述 临床核心）。DOMC还将协助从TBRU收集基本和翻译数据 研究人员帮助系统生物学核心所需的数据管理和结构， 基因组学和系统生物学分析方法。