PROTOCOL REVIEW AND MONITORING SYSTEM
方案审查和监测系统
基本信息
- 批准号:7944683
- 负责人:
- 金额:$ 4.64万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2009
- 资助国家:美国
- 起止时间:2009-04-21 至 2013-11-30
- 项目状态:已结题
- 来源:
- 关键词:AddressAmendmentAreaBenefits and RisksBiometryBudgetsCancer Center Support GrantCancer PatientClinicalClinical OncologyClinical Practice GuidelineClinical ResearchClinical TrialsClinical Trials Data Monitoring CommitteesClinical trial protocol documentCommittee MembersConflict of InterestDataDevelopmentDiseaseDisorder by SiteEnsureFrequenciesFunding AgencyInformed ConsentLeftLettersLifeMalignant NeoplasmsMediationMedicalMonitorNorris Cotton Cancer CenterOncology GroupPatientsPersonsPhasePhysician ExecutivesPreparationPrincipal InvestigatorProceduresProcessProtocols documentationPublicationsRecruitment ActivityReportingResearchResearch Ethics CommitteesResearch PersonnelResourcesReview CommitteeRightsRiskSafetyScheduleSystemVotingVoting RightWritinganticancer researchbasecancer preventioncollegecooperative studydata integritydesignfallshuman subjecthuman subject protectionmeetingsmemberpatient populationprogramstumor registryworking group
项目摘要
Since January 1996, a scientific review committee (Clinical Cancer Research Committee¿CCRC) and a
Safety and Data Monitoring Committee (SDMC) have functioned at Norris Cotton Cancer Center. The CCRC
reviews each new clinical trial protocol prior to Institutional Review Board (IRB) review, and the SDMC
monitors safety and data integrity on a regular basis throughout the trial. Prior to IRB review, the NCCC
Office of Clinical Research (OCR) submits the protocol to the CCRC. The CCRC is responsible for the
scientific review of all new studies involving cancer patients or cancer prevention in human subjects. This
assessment involves a review of all scientific aspects of the study, including the required safety and data
monitoring plan. Once a protocol receives CCRC and IRB approval, the protocol is considered open for
activation.
自 1996 年 1 月以来,科学审查委员会(临床癌症研究委员会¿CCRC)和
安全和数据监测委员会 (SDMC) 在 Norris Cotton 癌症中心运作。中国儿童研究中心
在机构审查委员会 (IRB) 审查之前审查每个新的临床试验方案,并且 SDMC
在整个试验过程中定期监控安全性和数据完整性。在 IRB 审查之前,NCCC
临床研究办公室 (OCR) 将方案提交给 CCRC。 CCRC 负责
对所有涉及癌症患者或人类受试者癌症预防的新研究进行科学审查。这
评估涉及对研究的所有科学方面的审查,包括所需的安全性和数据
监测计划。一旦协议获得 CCRC 和 IRB 批准,该协议就被视为开放
激活。
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)
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LIONEL David LEWIS其他文献
LIONEL David LEWIS的其他文献
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{{ truncateString('LIONEL David LEWIS', 18)}}的其他基金
7HP349, an Integrin Activator to Treat Patients With anti-PD-1 Resistant Solid Tumors
7HP349,一种整合素激活剂,用于治疗抗 PD-1 耐药实体瘤患者
- 批准号:
10761171 - 财政年份:2023
- 资助金额:
$ 4.64万 - 项目类别:
Development of 7HP349, an oral integrin activator to enhance therapeutic responses to immune checkpoint inhibitors
开发 7HP349,一种口服整合素激活剂,可增强对免疫检查点抑制剂的治疗反应
- 批准号:
10261525 - 财政年份:2020
- 资助金额:
$ 4.64万 - 项目类别:
Toxicology, Pathology and Biodistribution Core (TPB Core)
毒理学、病理学和生物分布核心(TPB 核心)
- 批准号:
7982610 - 财政年份:2010
- 资助金额:
$ 4.64万 - 项目类别:
Protocol Review and Monitoring System (PRMS)
方案审查和监控系统 (PRMS)
- 批准号:
10554303 - 财政年份:1997
- 资助金额:
$ 4.64万 - 项目类别:
Protocol Review and Monitoring System (PRMS)
方案审查和监控系统 (PRMS)
- 批准号:
10311241 - 财政年份:1997
- 资助金额:
$ 4.64万 - 项目类别:
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