UZ-UCSF Clinical Trials Unit

描述(由申请人提供)：津巴布韦大学-加州大学旧金山分校临床试验中心(UZ-UCSF CTU)的目标是提供科学领导力、组织良好和高效的研究支持基础设施，甚至高容量的临床研究站点(CRS)，以在津巴布韦进行最先进的艾滋病毒/艾滋病预防和治疗干预试验，并可能在南部非洲和其他受影响严重的地区应用。目前，津巴布韦有三个参与艾滋病网络活动的研究方案：1)UZ-UCSF艾滋病毒预防试验股(HPTN Funding)；2)UZ-临床研究中心(ACTG和HPTN Funding)；以及3)UZ儿科艾滋病临床试验股(PACTG Funding)，每个都有完善的CRS。我们建议整合这三个计划及其七个CRS，以继续实施12个过渡方案(HPTN 035、046、052；ACTG A5175、A5199、A5221、A5208、A5225；以及PACTG A5190/P1054)，并在未来进行附属于四个DAIDS网络的试验：成人临床试验小组(ACTG)、HIV预防试验网络(HPTN)、国际母婴青少年艾滋病临床试验(IMPAACT)和杀微生物剂试验网络(MTN)。我们的CTU汇集了来自世界各地最好的研究和公共卫生机构的许多世界领先的研究人员。这项建议的具体目标是：目标1.通过将现有的三个研究项目整合到一个中央基础设施中来发展一个综合的临床试验单位，以实施与四个DAIDS临床试验领导小组相关的现有过渡方案，并扩大我们参与未来试验的科学和后勤能力。目标1.a.提供科学领导，促进高质量的研究，为优先研究领域做出贡献，监督有能力和多产的研究报告，并支持新研究人员的发展。目标1.B。开发集中的研究支持部分，以协调财政管理、质量保证和控制、监管、人类主题和道德、数据管理、实验室、药房、培训、社区咨询委员会联络以及UZ-UCSF CTU所有活动的咨询职能。目标1.C。加强我们的管理和沟通系统，以确保高质量的研究实施和对七个拟议的CRS的有效监督。目标1.d.管理临床方案从当前的评奖到拟议的CTU结构的过渡。目标2.科学地为以下四个网络的研究活动的领导和优先次序作出贡献：ACTG、HPTN、IMPAACT和MTN。目标3.通过有效的外展和沟通以及社区咨询委员会(CAB)的参与，在CTU临床研究活动中实现有意义的社区伙伴关系。目标4.与已建立的临床研究站点合作，这些站点具有已被证明的能力、经验和科学生产力记录。 管理组件：

DESCRIPTION (provided by applicant): The goal of the University of Zimbabwe-University of California San Francisco Clinical Trials Unit (UZ-UCSF CTU) is to provide scientific leadership, a well organized and efficient research-support infrastructure, and even high-capacity Clinical Research Sites (CRS) to conduct state-of-the-art HIV/AIDS prevention and treatment intervention trials in Zimbabwe, with potential application throughout southern Africa and other highly affected regions. Currently there are three research programs in Zimbabwe that participate in DAIDS network activities: 1) UZ-UCSF HIV Prevention Trials Unit (HPTN funding); 2) the UZ-Clinical Research Centre (ACTG and HPTN funding); and 3) the UZ Pediatric AIDS Clinical Trials Unit (PACTG funding), each with well-established CRS. We propose to integrate the three programs and seven of their CRS to continue implementation of 12 transitional protocols (HPTN 035, 046, 052; ACTG A5175, A5199, A5221, A5208, A5225; and PACTG A5190/P1054), and to conduct future trials affiliated with four DAIDS networks; the Adult Clinical Trials Group (ACTG), HIV Prevention Trials Network (HPTN), the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT), and Microbicides Trial Network (MTN). Our CTU brings together many of the world's leading researchers from the finest research and public health institutions around the world. The specific aims in this proposal are to: Aim 1. Develop an integrative Clinical Trials Unit by consolidating three existing research programs into a centralized infrastructure to implement existing transitional protocols associated with four DAIDS Clinical Trials Leadership Groups, and to expand our scientific and logistical capacity to participate in future trials. Objective 1 .a. Provide scientific leadership that promotes high quality research, contributes to priority research areas, oversees capable and productive CRS and supports the development of new researchers. Objective 1 .b. Develop centralized research support components to coordinate fiscal management, quality assurance and control, regulatory, human subjects and ethics, data management, laboratory, pharmacy, training, community advisory board liaison, and counseling functions for all UZ-UCSF CTU activities. Objective 1 .c. Strengthen our management and communication systems to ensure high quality research implementation and effective oversight of the seven proposed CRS. Objective 1 .d. Manage transition of clinical protocols from current awards to the proposed CTU structure. Aim 2. Contribute scientifically to the leadership and prioritization of research activities in four networks: ACTG, HPTN, IMPAACT, and MTN. Aim 3. Achieve meaningful community partnership in the CTU clinical research activities through effective outreach and communication and Community Advisory Board (CAB) participation. Aim 4. Work with established clinical research sites that have proven capacity, experience and a record of scientific productivity. ADMINISTRATIVE COMPONENT: