COVID-19: NIAID Regulatory Support Center

该合同的目的是为NIAID监管支持中心（RSC）的运营和管理提供监管专业知识和支持，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：1)开展niaid资助和赞助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的培训；3)在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。

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).