Washington University Institute of Clinical and Translational Sciences
Washington University Institute of Clinical and Translational Sciences
批准号:
10700256
负责人:
William G. Powderly
金额:
$5.4万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2022
资助国家:
美国
项目状态:
未结题
起止时间:
2022-11-21 至 2027-02-28
关键词:
AccelerationAdministrative SupplementAdvocateAffectAwardBiometryClinical ResearchClinical SciencesClinical and Translational Science AwardsCollaborationsCommunitiesCommunity HealthComplexCost SharingData SetDecision MakingDedicationsDocumentationEcosystemEffectivenessElectronic MailEnsureEvaluationFacultyFundingGoalsGrantHealthHealthcare SystemsHomeHuman ResourcesHuman Subject ResearchIllinoisIndividualInformaticsInstitutionInterdisciplinary StudyLifeLongevityMentorsMethodsMissouriMulticenter TrialsNational Center for Advancing Translational SciencesNotificationOutcomeParentsParticipantPatientsPilot ProjectsPopulationPopulation HeterogeneityPositioning AttributeProcessProductivityQualifyingQuality ControlResearchResearch PersonnelRoleRural PopulationScienceSpecial PopulationSpecific qualifier valueSystemTechnologyTimeTraining ProgramsTranslatingTranslational ResearchTranslationsUnited States National Institutes of HealthUniversitiesUrban PopulationWashingtonWorkWorkforce Developmentarchived dataclinical applicationcommunity engaged researchdigitaldiverse dataeducation researchhealth disparityhuman subjectimplementation designimplementation scienceimprovedinnovationinteroperabilitymultidisciplinarynovelpopulation healthprogramsquality assuranceresponsetranslational impact
中文摘要
项目摘要
本申请是作为对母公司奖励UL 1 TR 002345的补充而响应NOT-TR-20-014提交的,
华盛顿大学临床和转化科学研究所(WU ICTS)。NCATS之前
临床和转化科学奖(CTSA)人类受试者研究(HSR)的审批流程
要求将研究信息输入NIH eRA人类受试者系统(HSS)。这一要求
适用于由CTSA赠款资助或自愿承诺费用分摊直接支持的试点项目,
KL 2奖学金项目涉及高铁。将这些研究与NCAT规定的
在项目开始之前,需要文件和电子邮件通知。
本CTSA管理补充文件的总体目标是增加专门的质量保证/质量
控制位置到WU ICTS行政核心。他们的角色是与KL 2协调和合作
学者和试点PI关于向NCATS提交CTSA相关材料、向HSS提交材料,以及
这是一个全面的事前审批过程。具体目标如下。
目标1:QA/QC人员将监督和管理人类受试者研究(HSR)的内部流程
事先批准请求,以促进一致性和效率,并加强提交成功的
向NCATS提供与CTSA有关的信息包。
目标2:质量保证/质量控制人员将执行一项综合评价战略,以指导决策,
确保过程的持续改进。
英文摘要
PROJECT SUMMARY
This application is submitted in response to NOT-TR-20-014 as a supplement to Parent Award UL1TR002345,
the Washington University Institute of Clinical and Translational Sciences (WU ICTS). The NCATS prior
approval process for Clinical and Translational Science Awards (CTSA) human subject research (HSR)
requires study information to be entered into the NIH eRA Human Subjects System (HSS). This requirement
applies to Pilot projects supported directly with CTSA grant funding or voluntary committed cost sharing and
KL2 Scholar projects that involve HSR. The entry of these studies into the HSS along with NCATS-specified
documentation and email notification are required before the project can begin.
The overall goal of this CTSA Administrative Supplement is to add a dedicated Quality Assurance/Quality
Control position to the WU ICTS Administrative Core. Their role is to coordinate and collaborate with KL2
Scholars and Pilot PIs regarding CTSA-related submissions to NCATS, submissions to the HSS, and
management of this overall prior approval process. The specific aims are included below.
Aim 1: QA/QC personnel will oversee and manage internal processes for human subjects research (HSR)
prior approval requests to facilitate consistency and efficiency and enhance the submission of successful
CTSA-related information packages to NCATS.
Aim 2: QA/QC personnel will implement a comprehensive evaluation strategy to guide decision-making and
ensure continuous improvement in processes.
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会议论文
Washington University Institute of Clinical and Translational Sciences
-
批准号:10827727
-
项目类别:
-
资助金额:$23.33万
-
财政年份:2023
-
负责人:William G. Powderly
-
依托单位:
WASHINGTON UNIVERSITY INSTITUTE OF CLINICAL AND TRANSLATIONAL SCIENCES
-
批准号:10321102
-
项目类别:
-
资助金额:$6.77万
-
财政年份:2017
-
负责人:William G. Powderly
-
依托单位:
Washington University Institute of Clinical and Translational Sciences
-
批准号:10556449
-
项目类别:
-
资助金额:$1016.11万
-
财政年份:2017
-
负责人:William G. Powderly
-
依托单位:
Washington University Institute of Clinical Translational Sciences
-
批准号:9889200
-
项目类别:
-
资助金额:$935.96万
-
财政年份:2017
-
负责人:William G. Powderly
-
依托单位:
Washington University Institute of Clinical and Translational Sciences
-
批准号:10598597
-
项目类别:
-
资助金额:$1017.84万
-
财政年份:2017
-
负责人:William G. Powderly
-
依托单位:
WU INSTITUTE OF CLINICAL AND TRANSLATIONAL SCIENCES
-
批准号:10217859
-
项目类别:
-
资助金额:$33.96万
-
财政年份:2017
-
负责人:William G. Powderly
-
依托单位:
Rosiglitazone & Exercise Training: Effects on HIV-Infected People
-
批准号:6971952
-
项目类别:
-
资助金额:$5.84万
-
财政年份:2004
-
负责人:William G. Powderly
-
依托单位:
STUDY OF ONCE-WEEKLY ALENDRONATE IN HIV-INFECTED SUBJECTS
-
批准号:6971984
-
项目类别:
-
资助金额:$0.52万
-
财政年份:2004
-
负责人:William G. Powderly
-
依托单位:
WU 122: EVALUATE METABOLIC EFFECTS OF DISCONTINUATION OF ANTIRETROVIRAL THERAPY
-
批准号:6971971
-
项目类别:
-
资助金额:$0.59万
-
财政年份:2004
-
负责人:William G. Powderly
-
依托单位:
CORE--CLINICAL FACILITY
-
批准号:6649912
-
项目类别:
-
资助金额:$28.97万
-
财政年份:2002
-
负责人:William G. Powderly
-
依托单位:
CORE--CLINICAL FACILITY
-
批准号:6492757
-
项目类别:
-
资助金额:$28.97万
-
财政年份:2001
-
负责人:William G. Powderly
-
依托单位:
PATIENT RECRUITMENT & CLINICAL MANAGEMENT CORE
-
批准号:6382005
-
项目类别:
-
资助金额:$23.1万
-
财政年份:2000
-
负责人:William G. Powderly
-
依托单位:
CORE--CLINICAL FACILITY
-
批准号:6340653
-
项目类别:
-
资助金额:$11.18万
-
财政年份:2000
-
负责人:William G. Powderly
-
依托单位:
PATIENT RECRUITMENT & CLINICAL MANAGEMENT CORE
-
批准号:6215534
-
项目类别:
-
资助金额:$23.16万
-
财政年份:2000
-
负责人:William G. Powderly
-
依托单位:
PATIENT RECRUITMENT & CLINICAL MANAGEMENT CORE
-
批准号:6524489
-
项目类别:
-
资助金额:$23.1万
-
财政年份:2000
-
负责人:William G. Powderly
-
依托单位:
PATIENT RECRUITMENT & CLINICAL MANAGEMENT CORE
-
批准号:6644769
-
项目类别:
-
资助金额:$23.1万
-
财政年份:2000
-
负责人:William G. Powderly
-
依托单位:
OUTCOMES COMMITTEE AGENDA
-
批准号:6099219
-
项目类别:
-
资助金额:$19.46万
-
财政年份:1999
-
负责人:William G. Powderly
-
依托单位:
OUTREACH AGENDA
-
批准号:6099220
-
项目类别:
-
资助金额:$19.46万
-
财政年份:1999
-
负责人:William G. Powderly
-
依托单位:
CORE--CLINICAL FACILITY
-
批准号:6201154
-
项目类别:
-
资助金额:$11.18万
-
财政年份:1999
-
负责人:William G. Powderly
-
依托单位:
HIV DISEASE RESEARCH AGENDA
-
批准号:6099213
-
项目类别:
-
资助金额:$19.46万
-
财政年份:1999
-
负责人:William G. Powderly
-
依托单位:
海外基金