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(管理核心) 拟议的TBRU应用程序将得到一个行政核心结构的支持，以协助、协调 并维护结核病研究股、该股的研发进度、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设在 在专用套件中进行物理操作，并共享为结核病研究开发的基础设施 位于罗格斯-NJMS园区的国际公共卫生中心(ICPH)大楼。核心负责人是奥兰德博士 共同领导--David Hom先生和Francesca Escaleira女士。 具体目标： 1.发展和运营行政(财政、监管)、业务(科学、物流)基础设施 和数据管理中心，能够支持拟议的临床、动物和翻译方案。 2.根据NIH政策维护财务合规性和现场报销程序。 3.与NIH项目工作人员沟通和合作，监控研究进展并实现里程碑。 4.协调和协作其他TBRU项目，以利用网络中的专业知识。 将部署一个管理计划和系统来维持特设局的运作，包括 财务、行政/监管合规活动、联检组内部沟通、各委员会和 通过TBRU-N、程序性DMID和TBRU会议、主办方互动、进度报告、补充 协助首席调查员进行项目评估。适当且有经验 财务分析师、行政协调员可负责项目执行和颁奖后管理。 位于新兴市场中心的现有数据中心-数据和运营管理中心(DMC) 病原体(由David Alland博士指导)将提供一个全面的数据管理计划，包括 组织、协调和验证临床数据、标本(MTB)收集的适当系统 菌株和血液样本)从拟议的临床方案。DMC所接受的培训，经验丰富 曾在乌干达和巴西从事临床研究的工作人员。对收集的数据进行验证和管理 将由数据中心维护，并由临床核心进行监控。一种标本储存库系统 (基于FreezerPro网络平台)将对收集的结核分枝杆菌菌株和血液样本进行维护(描述 在临床核心中)。DOMC还将协助从TBRU收集基本和转换数据 调查人员协助系统生物学核心进行统计所需的数据管理和结构， 基因组学和系统生物学分析方法。