关键词: 新型冠状病毒感染, 药物临床试验, 受试者管理

Abstract: Since the outbreak of the COVID-19 in 2020, drug clinical trials in China have faced unprecedented challenges, including issues such as missed subject visits and dropouts. In accordance with the national and local government requirements for COVID-19 prevention and control, the Jinling Hospital has strengthened personnel training, coordination, and communication among departments, adjusted follow-up methods in a timely manner, optimized follow-up management processes, and ensured subject compliance during follow-up visits, thus ensuring the smooth progress of drug clinical trials. This article summarizes the management experience of drug clinical trials in the National Clinical Research Center for Kidney Diseases during the COVID-19 pandemic,aiming to provide references and guidance for other institutions in China when managing subjects in drug clinical trials during emergencies.

Key words: COVID-19, clinical drug trials, subject management