Core A: Administration and Clinical Trial Coordination Core
Core A: Administration and Clinical Trial Coordination Core
批准号:
10700020
负责人:
Robert S Negrin
金额:
$25.28万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
1997
资助国家:
美国
项目状态:
已结题
起止时间:
1997-05-01 至 2024-08-31
关键词:
Animal ExperimentsAreaAutologous TransplantationAwarenessBiometryBone Marrow TransplantationCaliforniaCell TherapyCellsClinicalClinical TrialsClinical Trials Data Monitoring CommitteesCommunicationConduct Clinical TrialsConsentConsent FormsCritiquesDataData CollectionEducationEligibility DeterminationEnrollmentEnsureExtramural ActivitiesFederal GovernmentGenderHomologous TransplantationHumanInstitutionInstitutional Review BoardsLaboratoriesLeadershipMalignant NeoplasmsMinorityMonitorPatientsProcessProductionProgram Research Project GrantsProtocols documentationReportingResearchResearch PersonnelResearch Project GrantsResearch ProposalsResourcesReview CommitteeRunningSeriesSerious Adverse EventServicesStandardizationUnited States National Institutes of HealthUniversitiesUniversity HospitalsVisitWomanWorkWritingclinical translationdata communicationdata integritydata managementfollow-uphuman subjectinternational centerleukemia/lymphomameetingsminority patientnoveloperationparticipant enrollmentprogramsprotocol development
中文摘要
核心A(管理和临床试验协调核心):项目总结/摘要
核心A将作为整个计划项目赠款的行政中心。核心A将负责
与项目相关的所有财务事项,并与所有项目和核心领导人、行政管理人员
斯坦福大学的官员以及NIH官员,以确保研究的顺利和彻底的监督,
临床操作、财政和监管事宜。核心A将组织和运行每月的计划项目会议
每个项目以及核心B和C将每年向小组提交一至两次。核心A还将
每年组织一次为期一天的外部顾问访问,深入介绍每个项目和核心,
我们的外部顾问的批评和审查。将提供一份书面摘要,并分发给
合适的调查员。核心A还将负责协调拟定的临床试验,
标准化与斯坦福大学IRB、FDA(如适用)、斯坦福大学癌症研究所的互动,
NIH官员。核心A将负责开发研究临床方面的订单集,
知情同意合格患者,向适当监管机构报告严重不良事件,并支持
核心B的数据管理。核心A还将与斯坦福大学癌症研究所合作,提高认识
以及本申请中描述的临床试验中合格的妇女和少数民族患者的招募。芯A
将监测项目的科学和临床进展,并在需要时协调必要的变更,
修订,并确保核心B和C资源可用于使用这些服务的所有项目。
100.总之,核心A是本项目规划补助金的组织、协调和执行的一个组成部分。
英文摘要
Core A (Administration and Clinical Trial Coordination Core): Project Summary/Abstract
Core A will serve as the administrative hub for the entire Program Project Grant. Core A will be responsible for
all fiscal matters related to the Program and will interact with all of the Project and Core Leaders, administrative
officials at Stanford University as well as NIH Officers to ensure smooth and thorough oversight of research and
clinical operations, fiscal and regulatory matters. Core A will organize and run a monthly Program Project meeting
where each Project and Cores B and C will be presented to the group once to twice yearly. Core A will also
organize a yearly day long External Consultants Visit where each Project and Core will be presented in depth to
our external advisors for their critique and review. A written summary will be provided and distributed to
appropriate investigators. Core A will also be responsible for coordinating the proposed clinical trials by
standardizing interactions with the Stanford University IRB, FDA where indicated, Stanford Cancer Institute and
NIH Officials. Core A will be responsible for developing order sets for the clinical aspects of the studies,
consenting eligible patients, reporting severe adverse events to appropriate regulatory bodies and supporting
data management with Core B. Core A will also work with the Stanford Cancer Institute to enhance awareness
and enrollment of eligible women and minority patients to the clinical trials described in this application. Core A
will monitor scientific and clinical progress of the Projects and when needed coordinate necessary changes and
revisions as well as ensure availability of Core B and C resources to all of the Projects utilizing those services.
In summary, Core A is integral to the organization, coordination and implementation of this PPG.
期刊论文(0)
专著(0)
科研奖励(0)
会议论文
Regulatory T cells in allogeneic transplantation
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批准号:9065603
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资助金额:$52.2万
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财政年份:2012
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负责人:Robert S Negrin
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依托单位:
Regulatory T cells in allogeneic transplantation
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批准号:8903997
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项目类别:
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资助金额:$51.42万
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财政年份:2012
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Regulatory T cells in allogeneic transplantation
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批准号:8534275
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项目类别:
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资助金额:$49.7万
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财政年份:2012
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依托单位:
Regulatory T cells in allogeneic transplantation
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批准号:8701379
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项目类别:
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资助金额:$51.16万
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财政年份:2012
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依托单位:
Regulatory T cells in allogeneic transplantation
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批准号:8343992
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项目类别:
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资助金额:$52.02万
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财政年份:2012
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负责人:Robert S Negrin
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依托单位:
Allografting for Lukemia
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批准号:8260361
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项目类别:
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资助金额:$26.65万
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财政年份:2011
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负责人:Robert S Negrin
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依托单位:
Control of GVHD with Retained GVT
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批准号:8260364
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项目类别:
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依托单位:
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批准号:8181092
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财政年份:2010
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负责人:Robert S Negrin
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依托单位:
Regulatory T Cells in Allogeneic Transplantation
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批准号:7939868
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项目类别:
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资助金额:$75.03万
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财政年份:2009
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负责人:Robert S Negrin
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依托单位:
Regulatory T Cells in Allogeneic Transplantation
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批准号:7855234
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项目类别:
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资助金额:$118.43万
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NK Cells in GVHD and GVT
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批准号:7523519
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项目类别:
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财政年份:2008
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负责人:Robert S Negrin
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依托单位:
NK Cells in GVHD and GVT
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批准号:7673379
-
项目类别:
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资助金额:$29.49万
-
财政年份:2008
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负责人:Robert S Negrin
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依托单位:
NK Cells in GVHD and GVT
-
批准号:8265305
-
项目类别:
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资助金额:$28.55万
-
财政年份:2008
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负责人:Robert S Negrin
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依托单位:
NK Cells in GVHD and GVT
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批准号:7843638
-
项目类别:
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资助金额:$29.51万
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财政年份:2008
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负责人:Robert S Negrin
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依托单位:
NK Cells in GVHD and GVT
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批准号:8078125
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项目类别:
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资助金额:$28.59万
-
财政年份:2008
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负责人:Robert S Negrin
-
依托单位:
Administration and Research Coordination
-
批准号:7212915
-
项目类别:
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资助金额:$33.99万
-
财政年份:2007
-
负责人:Robert S Negrin
-
依托单位:
Allografting for Lukemia
-
批准号:7212894
-
项目类别:
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资助金额:$21.3万
-
财政年份:2007
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负责人:Robert S Negrin
-
依托单位:
PROG 8- Hematopoietic Cell Transplantation and
-
批准号:7438443
-
项目类别:
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资助金额:$1.7万
-
财政年份:2007
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负责人:Robert S Negrin
-
依托单位:
Control of GVHD with Retained GVT
-
批准号:7212898
-
项目类别:
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资助金额:$22.05万
-
财政年份:2007
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负责人:Robert S Negrin
-
依托单位:
Role of Regulatory T cells in GVHD, GVT, and Tolerance Induction
-
批准号:8269984
-
项目类别:
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资助金额:$27.99万
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财政年份:2004
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负责人:Robert S Negrin
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依托单位:
国内基金
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资助金额:--
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依托单位:
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负责人:史树中
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依托单位: