药物临床试验质量管理规范在医院管理中的融合与应用  

Integration and Application of New GCP into Hospital Management

作　　者：郭煜[1] GUO Yu(Shanxi Traditional Chinese Medical Hospital)

机构地区：[1]山西省中医院

出　　处：《中国标准化》2022年第20期254-256,共3页China Standardization

摘　　要：新版《药物临床试验质量管理规范》(Good Clinical Practice,简称GCP),自2020年7月1日起施行。目前,各医疗机构针对新版GCP受试者的医疗记录均使用人工干预流程,工作量大、可追溯性差、管理难度大。山西省中医院基于新版GCP管理模式,对医院信息系统进行了改造。实践证明,将GCP流程融入医院信息管理,既满足GCP规范要求,同时保证了数据的统一性、完整性、可追溯性。在提升患者就诊体验的同时,全面提升了医院的管理水平和管理效率。The revised Good Clinical Practice(GCP) has been implemented since July 1, 2020. At present, various medical institutions use manual intervention procedures for the medical records of GCP subjects, which has heavy workload with poor traceability and management difficulty. Based on the management model of the new GCP, Shanxi Traditional Chinese Medical Hospital has transformed the hospital information system. Practice has proved that integrating the GCP process into the hospital information management not only meets the requirements of the GCP specification, but also ensures the unity,integrity and traceability of data. While improving the patient experience, the hospital’s management level and efficiency have been comprehensively improved.

关 键 词：GCP应用 系统改造 数据可追溯 

分 类 号：R95[医药卫生—药学]