Analysis of the key points of on-site supervision and verification of phase I clinical trials of Corona Virus Disease-2019

Objective: To summarize the experience of phase I clinical trials of Corona Virus Disease-2019(COVID-19) vaccine, so as to provide reference for supervisors and researchers to strengthen clinical trial quality of COVID-19 vaccines in China Methods: Based on the comprehensive analysis of the rules and regulations pertaining to clinical research, ethical management, adverse events and the actual conditions of synchronous on-site supervision and verification, key points and supervision methods were identified Results and Conclusion: On-site supervision and verification mechanism synchronized with clinical researches was established On-site supervisors were dispatched, and supervision priorities, procedures and specific methods different from routine supervision were applied at the sites of clinical trials All these measures were helpful to complete elimination of any irregular, casual and false practice in clinical researches, and could effectively ensure the safety and efficacy of the vaccine when it was put on the market © 2020 Publishing House of Pharmaceutical Care and Research All rights reserved