Universidade Federal do Rio de Janeiro Clinical Trials Unit

里约热内卢联邦大学临床试验中心

• 批准号: 8040120
• 负责人: MAURO SCHECHTER
• 金额: $ 5.06万
• 依托单位: FEDERAL UNIVERSITY OF RIO DE JANEIRO
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-07-15 至 2010-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8040120
• 关键词: AIDS clinical trial group; Adult; Area; Blood; Body Fluids; Brazil; Clinical Trials; Clinical Trials Unit; Communities; Development; Enrollment; Good Clinical Practice; Government; HIV Infections; HIV Vaccine Trials Network; Laboratories; Leadership; Participant; Population; Process; Randomized; Recruitment Activity; Research; Research Ethics Committees; Research Priority; Resources; Screening procedure; Shipping; Ships; Site; Structure; Therapeutic Clinical Trial; Tissue Sample; clinical research site; design; experience; meetings

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:

描述（由申请人提供）： 拟定的临床试验单位位于巴西里约热内卢的里约热内卢联邦大学（UFRJ），仅包括一个临床研究中心，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HVTN领导应用程序。我们在进行NIH赞助的HIV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HVTN和ACTG领导力应用程序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采集、处理、储存和运送从临床试验参与者获得的血液、体液和组织样本至适当的中心实验室。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。我们也有一个记录在案的跟踪记录的招聘，筛选，登记，并遵循研究参与者在所有高优先级的研究领域，我们建议参加的损耗率非常低。该研究中心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，我们拥有参与制定两个网络的科学议程所需的专门知识，并有能力为设计和开展满足两个网络的科学议程所需的试验作出有效贡献。 行政部门：