Universidade Federal do Rio de Janeiro Clinical Trials Unit

描述（由申请人提供）：拟议的临床试验单元位于巴西里约热内卢里约热内卢联邦大学（UFRJ），仅包括一个临床研究点，称为Projeto Praqa Onze。我们建议加入艾滋病毒疫苗试验网络（HVTN）和成人艾滋病临床试验组（ACTG）。我们的网站被列入了HVTN领导力申请。我们在进行美国国立卫生研究院资助的艾滋病毒感染研究方面有超过10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，包括联邦范围的保证批准和一个满足美国政府要求的全面运作的机构审查委员会。我们已经记录了为执行HVTN和ACTG领导申请提出的研究议程而接触所需人群的情况。我们有能力根据良好临床实践标准进行严格的随机治疗性临床试验。我们有必要的设施来收集、处理、储存和运送临床试验参与者的血液、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丰富的经验。我们在招募、筛选、登记和跟踪研究参与者方面也有书面记录，在我们建议参与的所有高优先级研究领域，参与者的流失率都很低。场地的组织促进了各个研究领域之间的协同作用，有利于最佳利用可用资源。最重要的是，该网站拥有强大的社区支持。最后，我们有必要的专门知识来参与这两个网络的科学议程的制定，也有能力有效地为满足这两个网络的科学议程所需的试验的设计和实施作出贡献。

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: