New York University HIV/AIDS Clinical Trial Unit

纽约大学艾滋病毒/艾滋病临床试验中心

• 批准号: 7743393
• 负责人: JUDITH Ann ABERG
• 金额: $ 162.56万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-01-15 至 2013-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7743393
• 关键词: AIDS clinical trial group; AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Address; Adverse event; Case Report Form; Clinic; Clinical; Clinical Research; Clinical Trials; Clinical Trials Unit; Collaborations; Data; Data Reporting; Enrollment; Guidelines; HIV; HIV Seropositivity; HIV Vaccine Trials Network; HIV vaccine; Hospitals; Individual; Infection; International; Kenya; Laboratories; Laboratory Research; Life; Measurement; Monitor; National Institute of Allergy and Infectious Disease; New York; Participant; Persons; Primary Health Care; Process; Protocols documentation; Records; Recruitment Activity; Reporting; Research; Shipping; Ships; Site; Source; Specimen; Universities; Vaccines; Work; clinical care; clinical research site; design; meetings; preference; quality assurance

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:

描述（由申请人提供）： 纽约大学/贝尔维尤 CTU 的提案是支持三个临床研究中心、两个隶属于 ACTG 和 HVTN 的国内中心以及位于肯尼亚蒙巴萨的一个国际中心。目前，这三个单独的站点主要通过 NIAID 资助的艾滋病研究中心 (CFAR) 密切合作，该中心由 Fred Valentine 博士领导。应该指出的是，我们的 CFAR 刚刚在 2005 年退还了额外 5 年的期限。 ACTU 和疫苗研究的样本管理和实验室测量目前由同一 CFAR 实验室提供。 所有三个中心都展示了其招募、积累和保留研究对象的能力，这些研究涉及 RFA 中详述的高优先级科学研究。所有三个站点都满足 CRS 所需的功能：招募、筛选和登记参与者；执行协议要求的评估；管理研究产品；分配研究药物；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，由于她是贝尔维尤医院中心的 HIV 主任，她保证任何在参加 HIV 疫苗试验时成为 HIV 阳性的受试者都将得到适当和立即在贝尔维尤或该受试者偏好的诊所提供初级护理，以及评估原发感染的可用临床试验的信息。 ACTG 和 HVTN 对 HIV 感染者的临床护理做出了巨大贡献，所有国家指南中大量引用 ACTG 研究就反映了这一点。我们的单位对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。 行政部分：