新型冠状病毒肺炎流行期间早期临床试验病房应急管理指引

目的积极应对新型冠状病毒肺炎疫情,加强早期临床试验病房的应急管理工作。方法根据国家相关政策,结合药物临床试验领域实际情况,从启动尽早应急响应机制、分类实施人员管理、适时调整试验工作流程、加强病区环境管理、设置应急观察病房、后续机制常态化建设6个方面,提出疫情期间早期临床试验病房的应急管理指引。结果与结论加强并完善疫情期间早期临床试验病房的应急管理工作,规范疫情期间的药物临床试验行为,可以避免或减少人员交叉感染,为全社会抗击疫情贡献力量。

Guidelines for the Emergency Response Management of Early Clinical Trial Ward During the Outbreak of Coronavirus Disease 2019

Objective To actively respond to the coronavirus disease 2019(COVID-19)epidemic and strengthen the emergency response management of the early clinical trial ward.Methods According to the relevant national policies,combined with the actual situation in the field of drug clinical trials,the guidelines for emergency response management of early clinical trial wards during the epidemic period were put forward from six aspects:activating early emergency response mechanism,implementing personnel management by classification,timely adjusting the workflow of the clinical trial,strengthening the ward environmental management,setting up emergency observation ward and establishing mechanisms for normal operation.Results and Conclusion During the epidemic,strengthening and improving the emergency management of the early clinical trial ward and standardizing the drug clinical trial behavior can avoid or reduce the cross-infection of personnel and contribute to the fight against the COVID-19 epidemic.