New York University HIV/AIDS Clinical Trial Unit

描述(由申请人提供)： 纽约大学/贝尔维尤CTU的提议是支持三个临床研究站点，两个附属于ACTG和HVTN的国内站点，以及一个位于肯尼亚蒙巴萨的国际站点。这三个独立的网站目前在很大程度上通过NIAID赞助的艾滋病研究中心(CFAR)的努力进行密切合作，该中心由弗雷德·瓦伦丁博士领导。应该指出的是，我们的CFAR在2005年刚刚退还了额外的5年期。标本管理和实验室测量目前由相同的CFAR实验室为ACTU和疫苗研究提供。 所有这三个网站都证明了它们有能力招募、积累和留住研究对象，这些研究涉及RFA中详细说明的高度优先的科学研究。所有三个网站都符合CRS要求的以下能力：招募、筛选和登记参与者；执行方案要求的评估；管理研究产品；分发研究试剂；监测、评估和报告不良事件；收集、处理、储存和运送样本；收集、管理和提交符合网络所有数据报告要求的临床研究数据(S)；艾滋病规划署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、法规文件、受试者身份信息、临床报告和病例报告表。 作为CTU的PI，Aberg博士接受申请书中列出的主要责任，此外，由于她是贝尔维尤医院中心HIV主任，她向所有在参与HIV疫苗试验时艾滋病毒呈阳性的受试者保证，将立即在Bellevue或受试者偏好的诊所获得适当的初级保健，并提供有关评估初级感染的现有临床试验的信息。ACTG和HVTN为艾滋病毒携带者的临床护理做出了巨大贡献，这从所有国家指南中多次提到ACTG研究中可见一斑。我们单位对许多研究的概念和设计作出了重大的科学贡献，并将继续这样做。 管理组件：

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: