COVID-19: NIAID Regulatory Support Center

COVID-19：NIAID 监管支持中心

• 批准号: 10819113
• 负责人: ASIMAH RAFI
• 金额: $ 543.94万
• 依托单位: TECHNICAL RESOURCES INTERNATIONAL, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-15 至 2024-04-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10819113
• 关键词: Agreement; COVID-19; Clinical Research; Clinical Trials; Contracts; Data; Electronics; Funding; International; Investigational New Drug Application; Monoclonal Antibodies; National Institute of Allergy and Infectious Disease; Outpatients; Preparation; Protocols documentation; Records; Research; Research Activity; Research Personnel; Review Committee; Services; System; Training; clinical application; human subject protection; meetings; programs

The purpose of this contract is to provide regulatory expertise and support to operate and manage the NIAID Regulatory Support Center (RSC) to provide a wide range of clinical research activities and programs for NIAID. The RSC provides comprehensive regulatory support to: 1) perform NIAID-funded and NIAID-sponsored domestic and international clinical trial research; 2) provide training in key functions of clinical trial research to NIAID staff, investigators, and collaborators; and 3) maintain all contract-associated data and records in the NIAID-Clinical Research Management System (N-CRMS), including the electronic submission of required regulatory information. This project will provide regulatory support services for the COVID-19 clinical trial ACTIV-2 (Outpatient Monoclonal Antibodies And Other Therapies).

本合同的目的是提供监管专业知识和支持，以运营和管理NIAID监管支持中心（RSC），为NIAID提供广泛的临床研究活动和项目。RSC提供全面的监管支持，以：1）执行NIAID资助和NIAID申办的国内和国际临床试验研究; 2）为NIAID工作人员、研究者和合作者提供临床试验研究关键职能方面的培训; 3）在NIAID-临床研究管理系统（N-CRMS）中维护所有合同相关数据和记录，包括所需监管信息的电子提交。 该项目将为COVID-19临床试验ACTIV-2（门诊单克隆抗体和其他疗法）提供监管支持服务。