Administration Core

行政核心

• 批准号: 8533755
• 负责人: Ronald Hoffman
• 金额: $ 53.37万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-07-01 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8533755
• 关键词: Adverse event; Animals; Budgets; Clinical Trials; Communication; Contracts; Equipment and Supplies; Foundations; Funding; Geographic Locations; Institution; Investigational Drugs; Mediation; Monitor; Patients; Performance; Personnel Management; Pharmaceutical Preparations; Pharmacologic Substance; Progress Reports; Regulation; Reporting; Research; Research Infrastructure; Research Personnel; Resource Allocation; Resources; Schedule; Serious Adverse Event; Time; United States National Institutes of Health; Vertebrates; experience; human subject

The Administrative Core provides the infrastructure for and coordinates all activities of the MPD Research Consortium (MPD-RC). Key functions include organizational management and communication, resource allocation and management (personnel, funds,equlpment, and supplies), organization of all internal and external advisory boards, scientific and clinical trials oversight to assure regulatory cornpliarice and procedural implementation, and exetmal liaison to appropriate governmental agencies. The specific aims of the Administrative are: 1) coordinate activities of all projects, and cores belonging to the MPD-RC; 2) schedule and provide optimal staff support for all MPD-RC committees and boards and establish and staff new committees when necessary; 3) assure that the use of both human subjects and animal subjects is monitored in compliance with NIH regulations for research using human subjects and animals; 4) administer and oversee all budgets; 5) liaison to the NCI for all matters pertaining to the MPD-RC; 6) submit all applications for use of Investigational New Drugs (IND) to the U.S. Federal Drug Administration; 7) report all adverse events experienced by patients participating in clinical trials to investigators, participating instituions and appropriate regulatory agencies; 8) develop and negotiate contracts with pharmaceutical companies to gain access to drugs to be administered in clinical trials and obtain partial support from pharmaceutical companies for the performance of these trials; 9) prepare and provide yearly progress reports to the NCI.

行政核心为MPD研究联盟（MPD-RC）的所有活动提供了基础架构。关键功能包括组织管理和沟通，资源分配和管理（人员，资金，equlpment和供应），所有内部和外部咨询委员会的组织，科学和临床试验监督，以确保监管的玉米层和程序实施以及对适当的政府机构的exetmal联络。行政的具体目的是：1）协调所有项目的活动以及属于MPD-RC的核心； 2）安排并为所有MPD-RC委员会和董事会提供最佳的员工支持，并在必要时成立和员工新委员会； 3）确保根据使用人类受试者和动物的NIH研究来监测人类受试者和动物受试者的使用； 4）管理和监督所有预算； 5）与MPD-RC有关的所有事项与NCI联络； 6）向美国联邦药物管理局提交所有使用研究新药（IND）的申请； 7）报告参加临床试验的患者经历的所有不良事件向研究人员，参与机构和适当的监管机构进行； 8）与制药公司制定和谈判合同，以获取在临床试验中管理的药物，并从制药公司获得部分支持以进行这些试验； 9）为NCI准备并提供年度进度报告。