NIAID/Division of AIDS: Regulatory Support Center

NIAID/艾滋病司：监管支持中心

• 批准号: 10329831
• 负责人: ASIMAH RAFI
• 金额: $ 1524.71万
• 依托单位: TECHNICAL RESOURCES INTERNATIONAL, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-12-11 至 2021-04-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10329831
• 关键词: AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Amendment; Clinical Research; Clinical Trials; Collaborations; Contracts; Data; Development; Documentation; Funding; Government; HIV; Health; International; Investigational New Drug Application; Label; Link; National Institute of Allergy and Infectious Disease; Publications; Quality Control; Records; Regulation; Reporting; Research; Research Activity; Research Personnel; Resources; Safety; System; Training; Update; authority; meetings; pharmacovigilance; programs; quality assurance; web site

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.

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司（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。DAIDS RSC提供全面的监管支持，以：1）执行DAIDS资助和DAIDS赞助的国内和国际HIV临床试验研究; 2）为DAIDS工作人员，研究人员和合作者提供临床试验研究关键功能的培训;以及3）在DAIDS企业系统中维护所有与合同相关的数据和记录（DAIDS-ES）和NIAID-临床研究管理系统（N-CRMS），包括所需监管信息的电子提交。