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 总体计划目标雄心勃勃且复杂：迭代、理性、迅速地选择一个 安全有效的联合抗逆转录病毒（ARV）非疫苗生物医学预防（nBP）候选药物 体外、体内和临床测试，并建立为未来生产该候选药物的能力 临床研究。 IPCP-MBP 研究人员坚定致力于局部 nBP 的开发 候选人和输送系统，以防止艾滋病毒的性传播。为了实现这些目标，该计划 必须由强大的行政和监管核心（核心 A）运营。总体项目 PI、项目负责人、 关键人员拥有丰富的行政和监管经验，他们将这些经验带入成功 完成这个项目。 IPCP-MBP 的成功将依赖于核心 A 提供科学、监管和 协调五个科学项目、一个科学核心和多个科学项目的行政领导 组成此 IPCP-MBP 的调查员和站点。核心 A 的主要目标是有效促进 互动，为该计划的财政管理提供可靠的基础设施，提供持续的 与 NIH 和项目官员以及经批准的科学顾问小组 (SAP) 的沟通 NIH。它将通过促进各部门之间的沟通，为整个项目的有效领导提供重点。 执行委员会 (EC) 和指导委员会 (SC) 成员、项目调查员和工作人员。核心A将 还监控数据采集和共享，协调和监控材料和样品的交换 项目和核心之间的关系，以便研究以集成迭代的方式进行，以满足 个人项目和计划里程碑。核心 A 的监管方面将与 支持行政和科学人员参与获得 IACUC、IRB、PSRC 和 IND 批准 项目中需要。它将确保探索性临床试验的数据得到适当的管理和分析 满足核心 B 和项目 5 中制造和测试的所有 GMP 和 GLP 要求，并且 记录在案。