Administrative Core

行政核心

• 批准号: 7701150
• 负责人: Shan Lu
• 金额: $ 35.92万
• 依托单位: UNIV OF MASSACHUSETTS MED SCH WORCESTER
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-07-06 至 2014-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7701150
• 关键词: Adjuvant Study; Agreement; Antibodies; Antigens; Bioinformatics; Clinical; Clinical Protocols; Data; Development Plans; Drug Formulations; Funding Mechanisms; Genes; HIV Vaccine Trials Network; HIV vaccine; Human Resources; Information Management; Institution; Intellectual Property; Mediation; Monitor; Phase I Clinical Trials; Preparation; Proteins; Records; Reporting; Resource Sharing; Scientist; Standardization; Toxicology; U-Series Cooperative Agreements; United States National Institutes of Health; Work; cytokine; improved; nonhuman primate; programs; research clinical testing

The Administrative Core will be responsible for the overall management of this IPCAVD program according to PAR-06-286. The Administrative Core will be responsible for interacting with the DAIDS Program Officer and Staff as required by the U19 funding mechanism as a multi-project cooperative agreement between our team and NIH. The Administrative Core will also perform its duty to coordinate all aspects of routine program management on administrative, financial, regulatory, and clinical issues. The Administrative Core will organize and interact with external advisors, and host annual external reviews. Aim 1: To coordinate the interactions a) among scientists from different institutions included in the current program, and b) between our team and NIH personnel regarding efficient implementation of proposed plans and projects. Aim 2: To oversee all budgetary matters, including review and approval of subcontract agreements negotiated through the Project Management Group (PMG) of Project 3, and the monitoring of monthly expenses and preparation of various reports. Aim 3: To maintain records of pre-IND and IND application documents with the US FDA and coordinate efforts in IND filing and clinical protocol reviews required by different agencies, institutions, and committees. Aim 4: To work with HVTN to improve, implement, and execute the Clinical Development Plan including the timely start of clinical testing at HVTN of our modified multi-gene, polyvalent HIV vaccine formulation to be developed by this application. Aim 5: Information management: to provide bioinformatics and statistical support, to develop an Intellectual Property plan, and plans to promote data standardization, data and resource sharing.

行政核心将负责IPCAVD项目的全面管理