信息追溯技术在临床试验用药品全生命周期闭环管理中的应用浅析  

Superficial discussion on the application of information traceability technology in the closed-loop management of drugs for clinical trials in the whole life cycle

作　　者：杜静 陈红君 余自成 袁婷婷 DU Jing;CHEN Hongjun;YU Zicheng;YUAN Tingting(Drug Clinical Trial Institution,Yangpu Hospital,School of Medicine,Tongji University,Shanghai 200090,China)

机构地区：[1]同济大学附属杨浦医院药物临床试验机构,上海200090

出　　处：《药学服务与研究》2022年第1期58-61,共4页Pharmaceutical Care and Research

基　　金：国家自然科学基金项目(81302741);上海市科学技术委员会科研计划项目(19ZR1450600)。

摘　　要：加强临床试验用药品的闭环管理,对提高临床试验用药品管理质量,保证受试者用药安全具有重要意义。本文通过文献调研临床试验用药品生产制备、流通、回收和销毁等各环节的管理现状及临床试验用药品全生命周期的信息化管理现状,结合同济大学附属杨浦医院在临床试验用药品流通管理过程中发现的问题,提出信息追溯技术在临床试验用药品全生命周期闭环管理中的应用设想。该文对追溯码在临床试验用药品信息追溯管理应用的可行性进行分析,并对临床试验用药品信息追溯体系建设提出几点建议。Strengthening the closed-loop management of drugs for clinical trials is of great significance to improve management quality of drugs for clinical trials and ensure the safety of subjects.Through literature investigation and research of the present management status of clinical trial drugs(including preparation,circulation,recovery and destruction)and the informatization management status in the whole life cycle of drugs for clinical trials,and also in accordance with the problems identified in the process of drug managment for clinical trials,the idea of the application of information traceability technology in the closed-loop management of clinical trial drugs in the whole life cycle was proposed.This paper analyzed the feasibility of traceability code application to information traceability management of clinical trial drugs,and put forward recommendations for the construction of the information traceability system of clinical trial drugs.

关 键 词：临床试验用药品 全生命周期 闭环管理 信息追溯技术 追溯码 

分 类 号：R95[医药卫生—药学]