某三级医院药物临床试验机构疫情防控管制期间的运行管理策略与效果分析  

Operation Management Strategy and Effect Analysis of Drug Clinical Trial Institution in a Tertiary Hospital during Epidemic Prevention and Control Period

作　　者：许浩云[1] 邱春凤 郑建洪[3] XU Hao-yun;Qiu Chun-feng;ZHENG Jian-hong(Drug Clinical Trial Institution,School of Medicine,Xiamen University,Xiamen 361003,China;Department Of Preparation,School of Medicine,Xiamen University,Xiamen 361003,China;Department Of Pharmacy,the First Affiliated Hospital of Xiamen University,School of Medicine,Xiamen University,Xiamen 361003,China)

机构地区：[1]厦门大学附属第一医院药物临床试验机构,福建厦门361001 [2]厦门大学附属第一医院制剂科,福建厦门361001 [3]厦门大学附属第一医院药剂科,福建厦门361001

出　　处：《海峡药学》2023年第6期107-110,共4页Strait Pharmaceutical Journal

摘　　要：目的探讨医院药物临床试验机构疫情防控管制期间的运行管理策略并进行效果分析。方法针对各岗位工作人员相关工作内容采用GCP管理信息平台、微信群、邮件沟通等各种线上方式,制定出相应的应急管理策略。结果药物临床试验机构管理运行状况良好,所有在研的临床试验项目仅存在方案偏离,未因疫情原因导致项目的中止。结论重大突发公共卫生事件背景下,医院药物临床试验机构及时构建好临床试验数字化/智能化全生态链,可提高临床试验各方人员工作效率,减少院内感染,进而保障受试者安全。OBJECTIVE To explore the operation and management strategy of the hospital drug clinical trial institutions during the epidemic prevention and control period and analyze the effect.METHODS According to the relevant work contents of the staff at each post,various online methods such as GCP management information platform,WeChat group,email communication,etc.are adopted to formulate corresponding emergency management strategies.RESULTS The management and operation of drug clinical trial institutions are in good condition.All clinical trial projects under study only have protocol deviation,and the project is not suspended due to epidemic situation.CONCLUSION In the context of major public health emergencies,hospital drug clinical trial institutions should timely build a digital/intelligent whole ecological chain of clinical trials,which can improve the work efficiency of all parties to clinical trials,reduce hospital infection,and ensure the safety of subjects.

关 键 词：新冠 临床试验 管理策略 分析 

分 类 号：R969.4[医药卫生—药理学]