Universidade Federal do Rio de Janeiro Clinical Trials Unit

描述(由申请人提供)：拟议的临床试验单位位于巴西里约热内卢的联邦大学(UFRJ)，只包括一个临床研究地点，名为Projeto Praqa Onze。我们建议加入HIV疫苗试验网络(HVTN)和成人艾滋病临床试验小组(ACTG)。我们的网站被列入了HVTN领导力申请。我们在美国国立卫生研究院赞助的艾滋病毒感染研究方面有10多年的经验。因此，必要的设施以及监管、行政和财政结构已经到位，包括联邦范围的担保批准和一个全面运作的机构审查委员会，以满足美国政府的要求。我们已经记录了开展HVTN和ACTG领导力申请所提出的研究议程所需的人群。我们有能力根据良好的临床实践标准进行严格的随机治疗临床试验。我们有必要的设施来收集、处理、存储和运送从临床试验参与者那里获得的血液、体液和组织样本到适当的中心实验室。此外，我们在同时进行涉及数百名参与者的多项研究方面拥有相当多的经验。在我们计划参与的所有高优先级研究领域，我们也有记录在案的招募、筛选、登记和跟踪流失率非常低的研究参与者的记录。该网站的组织促进了不同研究领域之间的协同作用，有利于最佳利用现有资源。最重要的是，该网站拥有强大的社区支持。最后，我们拥有参与制定两个网络科学议程所需的必要专门知识，并有能力有效地为设计和开展满足两个网络科学议程所需的试验作出贡献。 管理组件：

DESCRIPTION (provided by applicant): The proposed clinical trials unit is located at Universidade Federal do Rio de Janeiro (UFRJ), in Rio de Janeiro, Brazil, and includes only one clinical research site, which is called Projeto Praqa Onze. We propose to affiliate with the HIV Vaccine Trials Network (HVTN) and with the Adult AIDS Clinical Trials Group (ACTG). Our site was listed in the HVTN Leadership application. We have over 10 years of experience in conducting NIH-sponsored studies of HIV infection. Thus, the necessary facilities as well as regulatory, administrative and fiscal structures are already in place, including a Federal-wide assurance approval and a fully functioning Institutional Review Board that meets U.S. government requirements. We have documented access to the populations needed for the conduct of the research agenda proposed by both the HVTN and the ACTG leadership applications. We have documented capability to conduct rigorous randomized therapeutic clinical trials according to Good Clinical Practice standards. We have the necessary facilities to collect, process, store, and ship to appropriate central laboratories blood, body fluids, and tissue samples obtained from clinical trial participants. Additionally, we have considerable experience in the simultaneous conduct of multiple studies involving several hundred participants. We also have a documented track record of recruiting, screening, enrolling, and following research participants with very low attrition rates in all high-priority research areas in which we propose to take part. The organization of the site promotes synergy between the various research areas, favoring the optimal use of available resources. Most importantly, the site has strong community support. Finally, we have the necessary expertise to participate in the development of the scientific agenda of both networks, as well as the capacity to effectively contribute to the design and conduct of trials needed to meet the scientific agenda of both networks. ADMINISTRATIVE COMPONENT: