Administrative Core

行政核心将根据以下规定负责本IPCAVD计划的全面管理： PAR-06-286行政核心将负责与DAIDS项目官员互动 根据U19资助机制的要求，作为我们之间的多项目合作协议， 团队和NIH。行政核心还将履行其职责，协调日常事务的各个方面， 管理行政、财务、法规和临床问题。行政核心 将组织外部顾问并与之互动，并主持年度外部审查。 目标1：协调a）来自目前研究所不同机构的科学家之间的互动 计划，以及B）我们的团队和NIH人员之间关于有效实施拟议计划 和项目 目标2：监督所有预算事项，包括审查和批准预算协定 通过项目3的项目管理小组谈判，并监测每月 费用和编制各种报告。 目标3：与美国FDA保持IND前和IND申请文件的记录，并协调 不同机构、研究所和委员会要求的IND申报和临床方案审查工作。 目标4：与HVTN合作，改进、实施和执行临床开发计划，包括 及时开始在HVTN的临床试验，我们的修改多基因，多价艾滋病毒疫苗配方， 由这个应用程序开发。 目标5：信息管理：提供生物信息学和统计支持， 产权计划，并促进计划数据标准化、数据和资源共享。

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.