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NIAID/Division of AIDS: Regulatory Support Center

NIAID/Division of AIDS: Regulatory Support Center
NIAID/艾滋病司：监管支持中心
批准号：
10610717
负责人：
ASIMAH RAFI
金额：
$1571.96万
依托单位：
TECHNICAL RESOURCES INTERNATIONAL, INC.
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
项目状态：
已结题
起止时间：
2022-04-15 至 2023-04-14
来源：
https://reporter.nih.gov/project-details/10610717
关键词：
AIDS/HIV problemAcquired Immunodeficiency SyndromeAmendmentClinical ResearchClinical TrialsCollaborationsContractsDataDevelopmentDocumentationFundingGovernmentHIVHealthInternationalInvestigational New Drug ApplicationLabelLinkNational Institute of Allergy and Infectious DiseasePublicationsQuality ControlRecordsRegulationReportingResearchResearch ActivityResearch PersonnelResourcesSafetySystemTrainingUpdateauthoritymeetingspharmacovigilanceprogramsquality assuranceweb site

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中文摘要
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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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