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（管理员核心） 拟议的TBRU申请将得到行政核心结构的支持，以协助，协调 并维护结核病研究部门，该部门的研发进度，沟通，互动 与内部和外部合作伙伴一起提供问题。管理员核心和数据中心将坐 在专门的套房中进行物理和共享用于结核病研究的基础设施和设施 国际公共卫生中心（ICPH）建筑物在Rutgers-NJMS校园上。核心负责人是Alland博士， 与共同领导者 - 大卫·霍姆先生和弗朗西斯·埃斯卡莱拉女士。 具体目的： 1。开发和运营行政（财政，监管），运营（科学，物流）基础架构 以及能够支持拟议的临床，动物和转化方案的数据管理中心。 2。根据NIH政策维护财政合规和现场报销程序。 3.与NIH计划人员进行交流和合作，以监视学习进度并取得里程碑。 4.协调并与其他TBRU计划合作，以利用网络跨网络的专业知识。 将部署管理计划和系统以维护TBRU的运营，包括 财务，行政/监管合规活动，部门内部的沟通，其委员会和 通过TBRU-N，程序化DMID和TBRU会议，赞助商互动，进度报告，补充 提交，并协助主要研究人员进行项目评估。合适的经验 财务分析师，行政协调员可用于计划行为和幕后管理。 现有的数据中心 - 新兴中心的数据和运营管理中心（DOMC） 病原体（由David Alland博士指导）将提供全面的数据管理计划 适当的系统以组织，协调和验证临床数据的收集，标本（MTB） 提议的临床方案中的菌株和血液样本）。 DOMC房屋经过训练，经验丰富 在乌干达和巴西工作的工作人员。验证和管理收集的数据 将由数据中心维护，由临床核心监测。标本存储库系统 （基于Freezerpro Web的平台）将用于收集的MTB菌株和血液样本（描述） 在临床核心）。 DOMC还将有助于收集TBRU的基本和翻译数据 研究人员帮助系统生物学核心要求的数据管理和结构 基因组和系统生物学分析方法。