Administrative Core

行政核心

• 批准号: 10665018
• 负责人: David Alland
• 金额: $ 13.52万
• 依托单位: RUTGERS BIOMEDICAL AND HEALTH SCIENCES
• 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/10665018
• 关键词: Animals; Award; Biological Specimen Banks; Blood specimen; Brazil; Clinical; Clinical Data; Clinical Protocols; Clinical Research; Collaborations; Collection; Communication; Data; Data Coordinating Center; Dedications; Genomics; Heterogeneity; Infrastructure; Institution; Lead; Logistics; Monitor; 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; web platform

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 应用程序将得到行政核心结构的支持，以协助、协调 并维护结核病研究单位、本单位的研发进度、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坐落 物理上位于专用套件内，并共享为结核病研究开发的基础设施和设备 位于罗格斯大学新泽西医学院校园内的国际公共卫生中心 (ICPH) 大楼。核心领导者是 Alland 博士， 与联合负责人 - David Hom 先生和 Francesca Escaleira 女士。 具体目标： 1. 开发和运营行政（财政、监管）、运营（科学、物流）基础设施 数据管理中心能够支持拟议的临床、动物和转化方案。 2. 根据 NIH 政策维持财务合规性和现场报销程序。 3. 与 NIH 项目人员沟通并合作，监控研究进展并实现里程碑。 4. 与其他 TBRU 项目协调和协作，以利用整个网络的专业知识。 将部署管理计划和系统来维持 TBRU 的运营，包括 财务、行政/监管合规活动、该单位、其委员会和 与 TBRU-N、程序化 DMID 和 TBRU 会议、发起人互动、进度报告、补充 提交材料，并协助首席研究员进行项目评估。合适且有经验 财务分析师、行政协调员可负责方案实施和授奖后管理。 现有数据中心 - 新兴中心的数据和运营管理中心 (DOMC) Pathogens（由 David 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、样本（MTB 菌株和血液样本）来自拟议的临床方案。 DOMC 拥有训练有素、经验丰富的 工作人员曾在乌干达和巴西从事临床研究。收集数据的验证和管理 将由数据中心维护，由临床核心监控。标本储存库系统 （FreezerPro 基于网络的平台）将维护收集的 MTB 菌株和血液样本（描述 在临床核心）。 DOMC 还将协助从 TBRU 收集基础数据和转化数据 研究人员帮助系统生物学核心所需的数据管理和结构进行统计， 基因组和系统生物学分析方法。