COVID-19: NIAID Regulatory Support Center

COVID-19：NIAID 监管支持中心

• 批准号: 10329832
• 负责人: ASIMAH RAFI
• 金额: $ 533.27万
• 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/10329832
• 关键词: Agreement; COVID-19; Clinical Research; Clinical Trials; Contracts; Data; 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).

该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计划。 RSC 为以下方面提供全面的监管支持： 1) 开展 NIAID 资助和 NIAID 赞助的国内和国际临床试验研究； 2) 向 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，包括以电子方式提交所需的监管信息。 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。