NIAID/DIVISION OF AIDS (DAIDS) DATA AND SAFETY MONITORING BOARD (DSMB) MEETING SUPPORT
NIAID/艾滋病司 (DAIDS) 数据和安全监测委员会 (DSMB) 会议支持
基本信息
- 批准号:9442646
- 负责人:
- 金额:$ 54.71万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2015
- 资助国家:美国
- 起止时间:2015-03-01 至 2017-11-14
- 项目状态:已结题
- 来源:
- 关键词:Acquired Immunodeficiency SyndromeAdverse eventClinical TrialsClinical Trials Data Monitoring CommitteesDataFundingGeographic LocationsIndividualInstitutesInstitutional Review BoardsLightMonitorNational Institute of Allergy and Infectious DiseaseOutcomePhasePhase I/II TrialPoliciesPreventionProtocols documentationRandomized Clinical TrialsRegulationReportingResearch PersonnelSafetySpecific qualifier valueTherapeuticU-Series Cooperative AgreementsUnited States National Institutes of HealthVaccinesclinical research sitemeetingsoperationphase II trialphase III trial
项目摘要
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,美国国立卫生研究院的政策要求所有多中心III期试验都有独立的数据和安全监测委员会(DSMB);最近的重述是在1998年发布的(NIH数据和安全监测政策,NIH指南通知98-084)。2000年提供了关于I期和II期试验的进一步NIH指导(关于I期和II期试验的数据和安全监测的进一步NIH指导,NIH指南通知OD-00-038)。鉴于联邦法规(45 CFR 46)赋予地方机构审查委员会(IRB)的相关监督责任,NIH在1999年增加了一项要求,即所有DSMB审查的结果都应通知地方机构审查委员会,即使没有建议进行重大更改,也要记录数据和安全监测按预期进行(向NIH支持的多中心临床试验机构审查委员会报告不良事件指南,NIH指南通知99-107)。这些国家卫生研究院的政策不解决实施问题,留给个别研究所和中心。因此,国家过敏和传染病研究所(NIAID)发布了自己的关于DSMB操作基本原则的政策。艾滋病司(DAIDS)主要通过常设DSMBs监测多中心随机临床试验的安全性和有效性。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
数据更新时间:{{ journalArticles.updateTime }}
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
BARBARA SINGER其他文献
BARBARA SINGER的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
{{ truncateString('BARBARA SINGER', 18)}}的其他基金
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:
9153265 - 财政年份:2015
- 资助金额:
$ 54.71万 - 项目类别:
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 - 财政年份:2015
- 资助金额:
$ 54.71万 - 项目类别:
YEAR1 FUNDING FOR NEI'S CONTRACT WITH CAPITAL CONSULTING CORPORATION: HHSN2632011
NEI 与 Capital Consulting Corporation 签订的合同的第一年资金:HHSN2632011
- 批准号:
8764613 - 财政年份:2011
- 资助金额:
$ 54.71万 - 项目类别:
THIS CONTRACT IS TO PROVIDE MEETING SUPPORT FOR THE NATIONAL EYE INSTITUTES (NEI)/OFFICE OF THE DIRECTOR (OD).
本合同旨在为国家眼科研究所 (NEI)/主任办公室 (OD) 提供会议支持。
- 批准号:
9369771 - 财政年份:2011
- 资助金额:
$ 54.71万 - 项目类别:
相似海外基金
Planar culture of gastrointestinal stem cells for screening pharmaceuticals for adverse event risk
胃肠道干细胞平面培养用于筛选药物不良事件风险
- 批准号:
10707830 - 财政年份:2023
- 资助金额:
$ 54.71万 - 项目类别:
Hospital characteristics and Adverse event Rate Measurements (HARM) Evaluated over 21 years.
医院特征和不良事件发生率测量 (HARM) 经过 21 年的评估。
- 批准号:
479728 - 财政年份:2023
- 资助金额:
$ 54.71万 - 项目类别:
Operating Grants
Analysis of ECOG-ACRIN adverse event data to optimize strategies for the longitudinal assessment of tolerability in the context of evolving cancer treatment paradigms (EVOLV)
分析 ECOG-ACRIN 不良事件数据,以优化在不断发展的癌症治疗范式 (EVOLV) 背景下纵向耐受性评估的策略
- 批准号:
10884567 - 财政年份:2023
- 资助金额:
$ 54.71万 - 项目类别:
AE2Vec: Medical concept embedding and time-series analysis for automated adverse event detection
AE2Vec:用于自动不良事件检测的医学概念嵌入和时间序列分析
- 批准号:
10751964 - 财政年份:2023
- 资助金额:
$ 54.71万 - 项目类别:
Understanding the real-world adverse event risks of novel biosimilar drugs
了解新型生物仿制药的现实不良事件风险
- 批准号:
486321 - 财政年份:2022
- 资助金额:
$ 54.71万 - 项目类别:
Studentship Programs
Pediatric Adverse Event Risk Reduction for High Risk Medications in Children and Adolescents: Improving Pediatric Patient Safety in Dental Practices
降低儿童和青少年高风险药物的儿科不良事件风险:提高牙科诊所中儿科患者的安全
- 批准号:
10676786 - 财政年份:2022
- 资助金额:
$ 54.71万 - 项目类别:
Pediatric Adverse Event Risk Reduction for High Risk Medications in Children and Adolescents: Improving Pediatric Patient Safety in Dental Practices
降低儿童和青少年高风险药物的儿科不良事件风险:提高牙科诊所中儿科患者的安全
- 批准号:
10440970 - 财政年份:2022
- 资助金额:
$ 54.71万 - 项目类别:
Improving Adverse Event Reporting on Cooperative Oncology Group Trials
改进肿瘤学合作组试验的不良事件报告
- 批准号:
10642998 - 财政年份:2022
- 资助金额:
$ 54.71万 - 项目类别:
Planar culture of gastrointestinal stem cells for screening pharmaceuticals for adverse event risk
胃肠道干细胞平面培养用于筛选药物不良事件风险
- 批准号:
10482465 - 财政年份:2022
- 资助金额:
$ 54.71万 - 项目类别:
Expanding and Scaling Two-way Texting to Reduce Unnecessary Follow-Up and Improve Adverse Event Identification Among Voluntary Medical Male Circumcision Clients in the Republic of South Africa
扩大和扩大双向短信,以减少南非共和国自愿医疗男性包皮环切术客户中不必要的后续行动并改善不良事件识别
- 批准号:
10191053 - 财政年份:2020
- 资助金额:
$ 54.71万 - 项目类别: