Core A: Administrative & Regulatory

核心A：行政

• 批准号: 8910625
• 负责人: Marc Michael Baum
• 金额: $ 18.13万
• 依托单位: OAK CREST INSTITUTE OF SCIENCE
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-08-01 至 2019-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8910625
• 关键词: AIDS prevention; Adherence; Amendment; Anti-Retroviral Agents; Clinical Protocols; Clinical Research; Clinical Trials; Collaborations; Committee Members; Communication; Complex; Contracts; Data; Development; Engineering; Ensure; Excipients; Future; Goals; Grant; HIV Infections; Human Resources; IACUC; In Vitro; Individual; Institutional Review Boards; Lead; Leadership; Manufacturer Name; Methods; Modification; Monitor; Persons; Pharmaceutical Preparations; Phase; Prevention; Protocols documentation; Qualifying; Research; Research Infrastructure; Research Personnel; Role; Running; Sampling; Scientist; Services; Site; System; Testing; United States National Institutes of Health; Vaginal Ring; Validation; Woman; data acquisition; data management; data sharing; design; empowered; experience; in vivo; meetings; pre-clinical; preclinical study; prevent; programs; research clinical testing; sexual HIV transmission; success

PROJECT SUMMARY: CORE A The Overall Program objectives are ambitious and complex: to iteratively, rationally, and expeditiously select a safe and effective combination antiretroviral (ARV) non-vaccine biomedical prevention (nBP) candidate through in vitro, in vivo, and clinical testing, and to establish the capability to manufacture this candidate for future clinical studies. The IPCP-MBP investigators are deeply committed to the development of topical nBP candidates and delivery systems to prevent the sexual transmission of HIV. To meet these goals, the Program must be run by a strong Administrative & Regulatory Core (Core A). The Overall Program PI, Project Leads, and key personnel have significant administrative and regulatory experience, which they bring to successfully complete this project. Success of this IPCP-MBP will rely on Core A to provide scientific, regulatory, and administrative leadership in coordinating the five Scientific Projects, one Scientific Core, and the multiple investigators and sites that make up this IPCP-MBP. Core A will have the primary goals of efficiently facilitating interactions, providing a reliable infrastructure for fiscal management of the Program, providing on-going communications with NIH and the Project Officer as well as the Scientific Advisory Panel (SAP) approved by NIH. It will provide focus for efficient leadership of the overall project by facilitating communication between the Executive Committee (EC) and Steering Committee (SC) members, project investigators, and staff. Core A will also monitor data acquisition and sharing, and coordinate and monitor the exchange of materials and samples between the Projects and Cores, so that the research progresses in an integrated iterative fashion to meet individual project and programmatic milestones. The regulatory aspect of Core A will coordinate with and support the administrative and scientific staff involved in gaining IACUC, IRB, PSRC, and IND approvals required in Projects. It will ensure data from the Exploratory Clinical Trial is properly managed and analyzed and that all GMP and GLP requirements for manufacture and testing in Core B and Project 5 are satisfied and documented.

项目摘要：核心A 总体计划目标是雄心勃勃且复杂的：在迭代，理性上，并迅速选择一个 安全有效的抗逆转录病毒（ARV）非疫苗生物医学预防（NBP）候选者通过 体外，体内和临床测试，并确定生产此候选人以后的能力 临床研究。 IPCP-MBP调查人员非常致力于发展局部NBP 候选人和交付系统，以防止艾滋病毒的性传播。为了满足这些目标，该计划 必须由强大的行政和监管核心（核心A）运行。 PO项目的总体计划PI， 关键人员具有丰富的行政和监管经验，他们成功带来了 完成此项目。 IPCP-MBP的成功将依靠核心A提供科学，监管和 行政领导协调五个科学项目，一个科学核心和多个科学核心 构成IPCP-MBP的调查人员和网站。核心A将具有有效促进的主要目标 互动，为该计划的财政管理提供了可靠的基础架构，提供了持续的 与NIH和项目官员以及科学咨询小组（SAP）批准的沟通 NIH。它将通过促进在 执行委员会（EC）和指导委员会（SC）成员，项目调查人员和员工。核心遗嘱 还可以监视数据获取和共享，并协调和监视材料和样品的交换 在项目和核心之间，研究以综合迭代方式进行以满足的方式进行 个人项目和程序化里程碑。核心A的监管方面将与 支持参与获得IACUC，IRB，PSRC和IND批准的行政和科学人员 项目中需要。它将确保对探索性临床试验的数据进行正确管理和分析 而且，核心B和项目5中制造和测试的所有GMP和GLP要求都满足，并且 记录。