NIAID/DIVISION OF AIDS: REGULATORY SUPPORT CENTER

NIAID/艾滋病司：监管支持中心

• 批准号: 9918806
• 负责人: ASIMAH RAFI
• 金额: $ 1086.76万
• 依托单位: TECHNICAL RESOURCES INTERNATIONAL, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-15 至 2020-04-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9918806
• 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 proposed 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.

拟议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)，从而为 DAIDS 提供广泛的艾滋病毒/艾滋病临床研究活动和计划。 DAIDS RSC 为以下方面提供全面的监管支持： 1) 开展 DAIDS 资助和 DAIDS 赞助的国内和国际 HIV 临床试验研究； 2) 向 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) 在 DAIDS 企业系统 (DAIDS-ES) 和 NIAID 临床研究管理系统 (N-CRMS) 中维护所有与合同相关的数据和记录，包括以电子方式提交所需的监管信息。