Core A. Administrative

行政核心的总体目的是提供科学的领导、组织管理 包括监管监督、行政、财政和人力资源服务以及与 这一多项目计划的主要利益相关者通过坚实、无缝的基础。这一核心对于 成功实施了所有四个单独项目。这对该计划的全面成功也至关重要 通过在一个保护伞下支持项目与核心之间的联系来支持该项目。这些联系最大限度地 科学产出，提高运营效率，确保与选民的和谐沟通。 行政核心将由Havlir博士(加州大学旧金山分校)和Kamya博士(Makerere大学)共同领导。一位经验丰富的人 管理团队将确保该计划的复杂运营部分，包括财政和 监管方面，运行平稳。合作研究是MU-UCSF的定义原则之一 组织。因此，与乌干达和美国合作伙伴的沟通是成功的关键。这些 利益攸关方包括卫生部(卫生部)、艾滋病支助组织(Taso)和Makerere。 乌干达大学和美国国家儿童健康与发展研究所(NICHD)。这个 管理核心将促进会议和通信、进度报告、呼叫安排和站点 赞助机构的来访。最后，核心将收到来自三个外部实体的反馈。一个外部的 科学咨询委员会(SAB)，由艾滋病毒(儿科、产科、抗逆转录病毒治疗)和疟疾专家组成 (治疗)将向该项目的科学领导层提供反馈。托罗罗社区咨询 委员会(CAB)将从社区的角度提供意见。数据安全与监控委员会(DSMB) 将提供对3项临床试验的持续审查。 目标1：提供科学领导，确保每个项目实现其科学目标。 科学指导委员会(SSC)将监督该计划中每个项目的进展。这 内部委员会将由每个单独项目和核心的首席调查员组成。 它将审查研究的整体进展情况，并协助项目调查人员克服出现的障碍 在研究过程中。SSC还将为项目领导提供一个分享科学发展的场所 在研究过程中。外部科学咨询委员会(SAB)将由五名外部人员组成 每年向SSC提供反馈意见的专家。Tororo驾驶室将为SSC提供 对社区看法的重要反馈，以及对问题的建议解决方案。将成立一个dsmb，以 评估项目目标和安全性。该委员会的建议将分发给校长。 对每个项目的调查员进行批判性审查。 目标2：为方案的所有方面提供组织管理，包括财务、 人力和资源管理以及监管监督。行政核心支持小组将 监督计划项目的整体运作，包括监管方面、预算方面和人力方面 资源管理、用品采购和运输，以确保有效管理所有这些 并适当地符合加州大学旧金山分校和马凯雷雷大学的政策。该团队还将协助 跟踪摘要、演示文稿和出版物。行政核心支持小组将包括这两个 加州大学旧金山分校和Makerere大学的工作人员，并每两周进行一次电话交流，以确保持续的沟通 两个站点之间的管理问题。首席调查员将与行政部门密切合作 在各自地点部署核心支持团队，以促进项目实施。 目标3：支持项目内的内部联系和与主要伙伴的外部联系 利益相关者。行政核心支持小组将发挥重要的“召集职能” 计划项目内的项目和核心，以确保整个计划项目大于 各部分的总和。行政核心将支持科学研讨会和年度科学研讨会。 研讨会。它还将促进与乌干达主要利益攸关方的沟通，包括 健康，塔索，还有托罗罗出租车。它的目标将是最大限度地促进和促进从总体上 项目，并与利益相关者合作，确保研究成果的传播。

The overall purpose of the Administrative Core is to provide scientific leadership, organizational management including regulatory oversight, administrative, fiscal and human resource services, and communications with key stakeholders for this multi-project program through a solid, seamless foundation. This core is critical to the successful implementation of all four individual projects. It is also critical for the overall success of the program project by supporting linkages between the projects and cores under one umbrella. These linkages maximize scientific output, create efficiencies in operations, and ensure harmonious communications with constituencies. The administrative core will be co-led by Drs. Havlir (UCSF) and Kamya (Makerere University). An experienced administrative team will ensure that the complex operational components of the program, including fiscal and regulatory aspects, run smoothly. Collaborative research is one of the defining principles of MU-UCSF organization. Therefore, communications with Ugandan and US partners is critical for success. These stakeholders include the Ministry of Health (MoH), The AIDS Support Organization (TASO), and Makerere University in Uganda, and the National Institute of Child Health and Development (NICHD) in the US. The Administrative Core will facilitate meetings and communications, progress reports, scheduling of calls, and site visits of the sponsoring agency. Finally, the core will receive feedback from three outside entities. An external Scientific Advisory Board (SAB) composed of experts in HIV (pediatric, obstetrics, ART) and malaria (therapeutics) will provide feedback to the scientific leadership of the project. A Tororo community advisory board (CAB) will provide input from the community perspective. A Data Safety and Monitoring Board (DSMB) will provide ongoing review of the 3 clinical trials. Objective 1: To provide scientific leadership to ensure that each project achieves its scientific goals. The Scientific Steering Committee (SSC) will oversee the progress of each of the projects in the program. This internal committee will be composed of the Principal Investigators of each of the individual projects and cores. It will review overall progress of the studies and assist the project investigators to overcome barriers that arise during the study. The SSC will also provide a venue for the project leadership to share scientific developments during the course of the study. The external Scientific Advisory Board (SAB) will be composed of five outside experts who will provide feedback to the SSC on an annual basis. The Tororo CAB will provide the SSC with important feedback on community perceptions and suggested solutions to problems. A DSMB will be formed to evaluate project objectives and safety. Recommendations from the DSMB will be disseminated to the Principal Investigators of each project for critical review. Objective 2: To provide organizational management of all aspects of the program, including fiscal, human and resource management, and regulatory oversight. The administrative core support team will oversee overall operations of the program project including regulatory aspects, budgetary, and human resource management, procurement of supplies, and transportation to ensure that all are managed effectively and appropriately in accordance with UCSF and Makerere University policy. This team will also assist in tracking abstracts, presentations and publications. The administrative core support team will include both UCSF and Makerere University staff and conduct biweekly calls to ensure ongoing communications on administrative issues between the sites. The Principal Investigators will work closely with the administrative core support team at their respective sites to facilitate project implementation. Objective 3: To support internal linkages within the project and external linkages with key stakeholders. The administrative core support team will serve an important "convening function" for the projects and cores within the program project to ensure that the whole of the program project is greater than the sum of its parts. The administrative core will support scientific seminars and an annual scientific symposium. It will also facilitate communications with key Ugandan Stakeholders including the Ministry of Health, TASO, and the Tororo CAB. It will aim to maximize and facilitate scientific output from the overall project and work with stakeholders to ensure dissemination of research findings.