IGF::OT::IGF - NIAID/DIVISION OF AIDS (DAIDS) DATA AND SAFETY MONITORING BOARD (DSMB) MEETING SUPPORT

IGF::OT::IGF - NIAID/艾滋病司 (DAIDS) 数据和安全监测委员会 (DSMB) 会议支持

• 批准号: 9233776
• 负责人: BARBARA SINGER
• 金额: $ 64.58万
• 依托单位: CAPITAL CONSULTING CORP
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-03-01 至 2017-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9233776
• 关键词: Acquired Immunodeficiency Syndrome; Address; Adverse event; Clinical Trials; Clinical Trials Data Monitoring Committees; Data; Funding; Geographic Locations; Individual; Institutes; Institutional Review Boards; Left; Light; Monitor; National Institute of Allergy and Infectious Disease; Outcome; Phase; Phase I/II Trial; Policies; Prevention; Protocols documentation; Randomized Clinical Trials; Regulation; Reporting; Research Personnel; Safety; Specific qualifier value; Therapeutic; U-Series Cooperative Agreements; United States National Institutes of Health; Vaccines; clinical research site; meetings; operation; phase III trial

NIH policy requiring independent data and safety monitoring boards (DSMB) for all multicenter Phase III trials has existed since 1979; the most recent restatement was issued in 1998 (NIH Policy for Data and Safety Monitoring, NIH Guide Notice 98-084). Further NIH guidance for Phase I and II trials was provided in 2000 (Further NIH Guidance on Data A Data and Safety Monitoring for Phase I and Phase II Trials, NIH Guide Notice OD-00-038). In light of the related responsibility for monitoring assigned to local Institutional Review Boards (IRB) by federal regulation (45 CFR 46), NIH added a requirement in 1999 that local IRBs be notified of the outcome of all DSMB reviews, even when no major change has been recommended, to document that data and safety monitoring is occurring as expected (Guidance on Reporting Adverse Events to Institutional Review Boards for NIH-Supported Multicenter Clinical Trials, NIH Guide Notice 99-107). These NIH policies do not address implementation matters, leaving those to individual Institutes and Centers. As a result, the National Institute of Allergy and Infectious Diseases (NIAID) has issued its own policy on basic principles for DSMB operations. The Division of AIDS (DAIDS) monitors safety and efficacy of multicenter randomized clinical trials primarily through standing DSMBs.

自1979年以来，NIH政策一直要求所有多中心III期试验均由独立的数据和安全性监测委员会（DSMB）进行监测;最近一次重述发布于1998年（NIH数据和安全性监测政策，NIH指南通知98-084）。2000年提供了进一步的NIH I期和II期试验指南（关于I期和II期试验数据A数据和安全性监测的进一步NIH指南，NIH指南通知OD-00-038）。根据联邦法规分配给当地机构审查委员会（IRB）的相关监查职责（45 CFR 46），NIH在1999年增加了一项要求，即应将所有DSMB审查的结果通知当地IRB，即使没有建议进行重大变更，记录数据和安全性监测按预期进行（NIH支持的多中心临床试验向机构审查委员会报告不良事件指南，NIH指南通知99-107）。 这些NIH政策不解决执行问题，将这些问题留给个别研究所和中心。因此，国家过敏和传染病研究所（NIAID）发布了自己的DSMB操作基本原则政策。 艾滋病司（DAIDS）主要通过常设DSMB监测多中心随机临床试验的安全性和有效性。