New York University HIV/AIDS Clinical Trial Unit

描述（由申请人提供）： NYU/Bellevue CTU的提案是支持三个临床研究中心，两个国内研究中心隶属于ACTG和HVTN，一个国际研究中心位于肯尼亚蒙巴萨。这三个独立的网站目前密切合作，主要是通过我们的NIAID赞助的艾滋病研究中心（CFAR）的努力，由弗雷德瓦伦丁博士指导。应该指出的是，我们的CFAR刚刚在2005年退还了额外的5年期。ACTU和疫苗研究的标本管理和实验室测量由相同的CFAR实验室提供。 所有三家研究中心均已证明其有能力招募、招募和保留RFA中详述的高优先级科学研究的受试者。所有三个研究中心均符合CRS要求的以下能力：招募、筛选和入组受试者;执行方案要求的评估;管理研究产品;分发研究药物;监测、评估和报告不良事件;采集、处理、储存和运输标本;收集、管理和提交临床研究数据，满足网络和DAIDS的所有数据报告要求，进行内部质量保证创建、维护和存储研究记录，包括参与者文件、源文件、监管文件，受试者识别信息、临床报告和病例报告表。 作为CTU的PI，Aberg博士接受申请中概述的主要职责，此外，她是贝尔维尤医院中心的HIV主任，她保证，任何在参加艾滋病毒疫苗试验时成为艾滋病毒阳性的受试者将在贝尔维尤或受试者偏好的诊所得到适当和立即的初级保健，以及关于评估初级保健的现有临床试验的信息。感染 ACTG和HVTN为艾滋病毒感染者的临床护理做出了巨大贡献，所有国家准则中多次提到ACTG研究就反映了这一点。我们的单位为许多研究的概念和设计做出了重大的科学贡献，并将继续这样做。 行政部门：

DESCRIPTION (provided by applicant): The NYU/Bellevue CTU's proposal is to support three Clinical Research Sites, two domestic sites affiliating with the ACTG and HVTN and one international site in Mombasa, Kenya. The three individual sites currently work in close collaboration largely through the efforts of our NIAID sponsored Center for AIDS Research (CFAR),directed by Dr. Fred Valentine. It should be noted that our CFAR was just refunded in 2005 for an additional 5 year period. Specimen management and laboratory measurements are cjrrently provided by the same CFAR laboratories for both the ACTU and Vaccine studies. All three sites have demonstrated their ability to recruit, accrue and retain subjects in studies addressing the high priority scientific research detailed in the RFA. All three sites meet the CRS- required capabilities to: recruit, screen, and enroll participants; perform protocol required assessments; manage study products; dispense investigational agents; monitor for, assess arid report adverse events; collect, process, store and ship specimens; collect, manage and submit clinical research data, that meets all data reporting requirements of the Network(s) and DAIDS conduct internal quality assurance create, maintain and store research records including participant files, source documents, regulatory files, subject identification information, clinical reports, and case report forms. As PI of the CTU, Dr. Aberg accepts the primary responsibilities outlined in the application and additionally as she is Director of HIV for Bellevue Hospital Center, she assures that any subjects who become HIV positive while participating in an HIV vaccine trial will be appropriately and immediately offered primary care either at Bellevue or a clinic of that subject's preference as well as information on available clinical trials evaluating primary infection. The ACTG and HVTN have contributed immensely to the clinical care of persons living with HIV as reflected by the numerous references to ACTG studies in all the national guidelines. Our unit has given significant scientific contributions to the concept and design of many studies and will continue to do so. ADMINISTRATIVE COMPONENT: