Clinical Research Operations and Management Support (CROMS)
Clinical Research Operations and Management Support (CROMS)
批准号:
10026533
负责人:
NANCY YOVETICH
金额:
$454.57万
依托单位国家:
美国
项目类别:
财政年份:
2019
资助国家:
美国
项目状态:
已结题
起止时间:
2019-09-30 至 2020-09-29
关键词:
ClinicalClinical ResearchClinical TrialsCollectionComputersConsultContractorContractsDataData AnalysesData CollectionData ReportingDevelopmentDevicesExtramural ActivitiesHuman ResourcesIntramural ResearchInvestigationInvestigational DrugsInvestigational New Drug ApplicationKnowledgeLaboratory ResearchManagement Information SystemsMonitorNational Institute of Dental and Craniofacial ResearchOperations ResearchPhasePreparationProceduresProtocols documentationQuality ControlReportingResearchResearch DesignResearch PersonnelResourcesRoleSafetySecureSerious Adverse EventServicesSiteStatistical Data InterpretationSystemTrainingUpdateWorkbasecentral databaseclinical research sitedata managementdesignexperiencepharmacovigilanceprogramsprotocol developmentresearch studysoundtoolweb site
中文摘要
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英文摘要
The purpose of this contract is to provide comprehensive clinical research operations support, management and data coordinating services for clinical research sponsored by NIDCR’s extramural and intramural research divisions. The contract will provide NIDCR with clinical research management support and oversight tools to assist in the effective administration and coordination of its clinical research program. In addition, it will provide adjunct expertise and resources to assure sound and efficient clinical study design, study execution, data management and analysis, and regulatory compliance. Specific tasks performed will vary by clinical study and clinical site, and will be dependent on the study’s protocol, standard operating procedures, and the roles/duties assigned to the Contractor by the NIDCR Contracting Officer’s Representative (COR).
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海外基金