摘要
目的:探索专科医院药物临床试验质量管理规范(GCP)药房的规范化管理,提高临床试验药物的管理水平。方法:根据新版GCP、《药物临床试验机构管理规定》等文件的要求并结合实际情况,建立GCP药房管理体系,包括药房设施设备、人员、制度以及试验药物的管理等标准操作规程的建立,总结存在的问题并持续改进。结果:我院临床试验药物的管理基本符合要求,可以保障受试者的用药安全。结论:我院已建立起规范的GCP药房,但仍须改进制度流程以满足新冠疫情防控要求,并探索建立电子信息化管理系统。
Objective:To explore the standardized management of good clinical practice(GCP)pharmacies in specialized hospitals and improve the management level of clinical trial drugs.Methods:The GCP pharmacy management system was established based on the requirement of the new version of GCP,“The Regulation on Administration of Drug Clinical Trial Institution”and other relative issues and the combination with the actual situation,including the establishment of the pharmacy equipment,personnel and the standard operating procedures of the system and test drugs management.The existed problems will be summarized and continuously improved.Results:The management of clinical trial drugs in our hospital basically met the requirements and would guarantee the drug administration safety for subjects.Conclusions:A standardized GCP pharmacy has been established in our hospital,but it is still necessary to further improve the system and process to meet the requirements of COVID-19 prevention and control and explore the establishment of the digital information management system.
作者
李静
沈剑文
黄滔敏
LI Jing;SHEN Jianwen;HUANG Taomin(Department of Pharmacy,Eye&ENT Hospital,Fudan University,Shanghai 200031,China)
出处
《上海医药》
CAS
2022年第9期54-57,共4页
Shanghai Medical & Pharmaceutical Journal
基金
上海市高水平地方高校创新团队——复旦大学上海医学院临床药学与监管科学重点创新团队建设项目(HJW-R-2019-66-19)。
