Clinical Research Operations and Management Support (CROMS)
Clinical Research Operations and Management Support (CROMS)
批准号:
10444968
负责人:
NANCY YOVETICH
金额:
$349.74万
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 2022-09-29
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
本合同的目的是为NIDCR的校外和校内研究部门赞助的临床研究提供全面的临床研究运营支持、管理和数据协调服务。该合同将为NIDCR提供临床研究管理支持和监督工具,以协助其临床研究计划的有效管理和协调。此外,它还将提供辅助专业知识和资源,以确保合理有效的临床研究设计、研究执行、数据管理和分析以及法规遵从性。所执行的具体任务将因临床研究和临床研究中心而异,并将取决于研究方案、标准操作规程以及NIDCR签约官员代表(COR)分配给承包商的角色/职责。
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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