重大突发公共卫生事件一级响应下药物临床试验机构对驻院临床研究协调员管理要点

Key points of CRC management in hospital by drug clinical trial institutions under the first level response to major public health emergencies

2020年初,严重急性呼吸综合征冠状病毒2(severe acute respiratory syndrome coronavirus 2,SARS-CoV-2)肆虐,防控情势严峻,全国大部分省市及地区相继宣布启动重大突发公共卫生事件一级响应。当前,如何在重大突发卫生事件一级响应下规范高效地对临床研究协调员(clinical research coordinator,CRC)进行管理,是药物临床试验机构亟需解决的问题。本文主要以一般情况下药物临床试验机构对驻院CRC管理为基础,对比一级响应下对驻院CRC的管理差异,提出管理要点,以期为特殊时期药物临床试验平稳有序进行提供参考。

At the beginning of 2020, due to the serious infection caused by severe acute respiratory syndrome coronavious 2(SARS-CoV-2), and the prevention and control situation was grim, most provinces, cities and regions in the country have successively announced the launch of first level response to major public health emergencies. Under such cirumstance, how to standardize and efficiently manage the clinical research coordinator(CRC) under the first level response to major health emergencies is an urgent problem to be solved by the drug clinical trial institutions. In this paper, based on the general situation of drug clinical trial institutions’ management of CRC in hospital,compared with the difference of management of CRC in hospital under first-level response,the key points of management were proposed,in order to provide a reference for the smooth an orderly drug clinical trials in special period.