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CORA Project - Gene Therapy for Metachromatic Leukodystrophy

CORA Project - Gene Therapy for Metachromatic Leukodystrophy
CORA 项目 - 异染性脑白质营养不良的基因治疗
批准号：
8548420
负责人：
CHARLEEN HOLLMANN
金额：
$19.78万
依托单位：
WEILL MEDICAL COLL OF CORNELL UNIV
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 2016-08-31
来源：
https://reporter.nih.gov/project-details/8548420
关键词：
Advisory CommitteesClinicalClinical ProtocolsClinical Trials Cooperative GroupCollectionComplexConduct Clinical TrialsConsultationsDataData AnalysesData CollectionDevelopmentDevelopment PlansElectronicsEligibility DeterminationEnsureEthicsFundingGene TransferGrantHumanIndividualInstitutionInstitutional Review BoardsInvestigational New Drug ApplicationMetachromatic LeukodystrophyMonitorNational Institute of Neurological Disorders and StrokePatientsPreparationProcessRecombinantsRegulatory AffairsReportingResearch SubjectsSeriesSystemTimeTrainingUnited States Food and Drug AdministrationUnited States National Institutes of Healthcomputerized data processingdata managementdesignexperiencegene therapyhuman studyinstitutional biosafety committeeoperationprotocol developmentquality assurancestatistics

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中文摘要
翻译
团队4 -临床运营/法规事务（CORA;制定临床方案，准备、提交并获得IRB、IBC、NIH OBA/RAC和FDA的批准，以及准备SOP和收集文件）
英文摘要
Team 4 - Clinical Operations/Regulatory Affairs (CORA; development of the clinical protocol, preparation, submission and obtaining approval from the IRB, IBC, NIH OBA/RAC and FDA, and preparation of SOPs and collection of documents)
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CORE--Clinical Operations and Regulatory Affairs ( CORA )
CORE--CLINICAL OPERATIONS AND REGULATORY AFFAIRS
CORE--CLINICAL OPERATIONS AND REGULATORY AFFAIRS
CORE--CLINICAL OPERATIONS AND REGULATORY AFFAIRS
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