Clinical Trials Office
Clinical Trials Office
批准号:
8376807
负责人:
YELENA NOVIK
金额:
$15.91万
依托单位国家:
美国
项目类别:
财政年份:
--
资助国家:
美国
项目状态:
已结题
起止时间:
至 2013-02-28
关键词:
AppointmentBudgetsCancer CenterCancer Center Support GrantClinicalClinical InvestigatorClinical ResearchClinical TrialsConduct Clinical TrialsCritiquesDataData AnalysesData CollectionData ReportingDevelopmentDiscipline of NursingEnsureEnvironmentFunding AgencyGoalsGrowthGuidelinesInstitutesInstitutionInstitutional Review BoardsMalignant NeoplasmsMedicalMedical centerModelingOutcomeProceduresProcessProtocols documentationQuality ControlResearchResearch PersonnelResourcesServicesTherapy Clinical TrialsTimeTranslatinganticancer researchdata managementimprovedinterdisciplinary collaborationmedical schoolsmeetingsnovelprogramsprotocol developmentquality assuranceresponsesuccess
中文摘要
临床试验办公室(CTO)为癌症提供行政、研究和教育服务
进行临床试验的研究所调查人员和研究人员。它是主要的协调中心
与癌症相关的临床试验,从概念开发和提交到结束,包括方案
发展、监管和合规指导、行政提交、数据收集和数据
管理、数据分析和质量控制功能,并作为与其他
纽约大学医学中心的临床研究机构。该资源的目标是:
通过为临床试验的开发、提交和实施提供框架来促进临床试验。
加强和促进临床癌症研究数据的数据收集和报告。
为CTO员工和临床研究人员提供培训课程。
促进跨学科合作和将研究成果转化为临床领域的场所
针对先前的批评、内部审计和对外部顾问的审查,重要的
自上次审查以来,CTO内部发生了变化。这些变化包括任命
新的医疗和行政主任、新的标准操作程序和数据重组
管理层。这些改进产生了更好地满足调查人员需求的CTO
在纽约大学医学院的临床研究环境中表现得更有效。目前,
CTO管理49名研究人员,管理158个开放协议。首席技术官继续扩大和
完善其职能,发挥临床研究企业的中心协调中心作用
纽约大学。
英文摘要
The Clinical Trials Office (CTO) provides administrative, research and educational services to the Cancer
Institute investigators and research staff conducting clinical trials. It serves as the main coordinating center
for cancer-related clinical trials from concept development and submission to closure including protocol
development, regulatory and compliance guidance, administrative submissions, data collection and data
management, data analysis, and quality control functions, and serves as the administrative interface to other
clinical research organizations at the NYU Medical Center. The goals of this resource are to:
Facilitate clinical trials by providing a framework for development, submission, and conduct of clinical trials.
Enhance and facilitate data collection and reporting of clinical cancer research data.
Provide educational programs for the CTO staff and clinical investigators.
Promote interdisciplinary collaboration and a venue for translating research findings to the clinical arena
In response to the previous critique, internal audits, and the review of external consultants, significant
changes have occurred within the CTO since the last review. These changes include the appointment of
new medical and administrative directors, new standard operating procedures, and restructuring of data
management. These improvements have produced a CTO that better meets the needs of investigators
performs more effectively within the NYU School of Medicine clinical research environment. Currently, the
CTO supervises 49 research staff and manages 158 open protocols. The CTO continues to expand and
improve its function to serve as the central coordinating center for the clinical research enterprise at the
NYUCI.
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Clinical Trials Office
-
批准号:8038255
-
项目类别:
-
资助金额:$17.43万
-
财政年份:2010
-
负责人:YELENA NOVIK
-
依托单位:
NSAPB-38: COMPARISON OF THREE CHEMOTHERAPY REGIMENS IN WOMEN WITH BREAST CANCER
-
批准号:7605761
-
项目类别:
-
资助金额:$0.99万
-
财政年份:2007
-
负责人:YELENA NOVIK
-
依托单位:
ECOG PACCT-1: TRIAL ASSIGNING INDIVIDUALIZED OPTIONS FOR TREATMENT
-
批准号:7605779
-
项目类别:
-
资助金额:$0.04万
-
财政年份:2007
-
负责人:YELENA NOVIK
-
依托单位:
NSAPB-38: COMPARISON OF THREE CHEMOTHERAPY REGIMENS IN WOMEN WITH BREAST CANCER
-
批准号:7378357
-
项目类别:
-
资助金额:$0.19万
-
财政年份:2006
-
负责人:YELENA NOVIK
-
依托单位:
Clinical Trials Office
-
批准号:8232214
-
项目类别:
-
资助金额:$16.56万
-
财政年份:--
-
负责人:YELENA NOVIK
-
依托单位:
海外基金