NIAID/Division of AIDS: Regulatory Support Center
NIAID/Division of AIDS: Regulatory Support Center
批准号:
10819112
负责人:
ASIMAH RAFI
金额:
$1623.53万
依托单位国家:
美国
项目类别:
财政年份:
2023
资助国家:
美国
项目状态:
已结题
起止时间:
2023-04-15 至 2024-04-14
关键词:
Acquired Immunodeficiency SyndromeAmendmentAuthorization documentationClinical ResearchClinical TrialsCollaborationsContractsDataDevelopmentDocumentationElectronicsFundingGovernmentHIVHIV/AIDSHealthInternationalInvestigationLabelLinkNational Institute of Allergy and Infectious DiseasePublicationsQuality ControlRecordsRegulationReportingResearchResearch ActivityResearch PersonnelResourcesSafetySystemTrainingUpdateauthoritymeetingsnovel therapeuticspharmacovigilanceprogramsquality assuranceweb site
中文摘要
该合同的目的是提供监管专业知识和支持,以运营和管理艾滋病部门(DAIDS)监管支持中心(RSC),为DAIDS提供广泛的艾滋病毒/艾滋病临床研究活动和计划。艾滋病RSC提供全面的监管支持:1)开展艾滋病基金会资助和资助的国内和国际艾滋病临床试验研究;2)为DAIDS工作人员、研究者和合作者提供临床试验研究关键职能的培训;3)维护DAIDS企业系统(DAIDS- es)和niaids临床研究管理系统(N-CRMS)中所有与合同相关的数据和记录,包括所需监管信息的电子提交。
英文摘要
The purpose of the contract is to provide regulatory expertise and support to operate and manage the Division of AIDS (DAIDS) Regulatory Support Center (RSC) to provide a wide range of HIV/AIDS clinical research activities and programs for DAIDS. The DAIDS RSC provides comprehensive regulatory support to: 1) perform DAIDS-funded and DAIDS-sponsored domestic and international HIV clinical trial research; 2) provide training in key functions of clinical trial research to DAIDS staff, investigators, and collaborators; and 3) maintain all contract-associated data and records in the DAIDS Enterprise System (DAIDS-ES) and NIAID-Clinical Research Management System (N-CRMS), including the electronic submission of required regulatory information.
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项目类别:
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财政年份:2012
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依托单位:
海外基金