全程动态管理模式在我院儿童药物临床试验质量控制中的应用及优化  

Application and Optimization of Whole Dynamic Management Model in Quality Control of Children 's Drug Clinical Trials

作　　者：王婷[1] 张志华[1] 何周康[1] 石绍南[1] Wang Ting;Zhang Zhihua;He Zhoukang;Shi Shaonan(Hunan Children＇s Hospital,Hunan Changsha 410007,China)

机构地区：[1]湖南省儿童医院,湖南长沙410007

出　　处：《儿科药学杂志》2018年第8期43-45,共3页Journal of Pediatric Pharmacy

基　　金：湖南省儿童医院2017年度院级科研课题;编号6-B

摘　　要：为保障受试者的安全和权益,保证临床试验的质量,确保药物临床试验活动中数据的真实、完整、规范及可溯源,药物临床试验质量控制在药物临床试验中起重要作用。我院药物临床试验的质量控制应用全程动态管理模式,并应用PDCA循环法持续改进,建立了三级质控体系和量化管理体系,以保证我院所承接的试验项目数据真实、完整、规范及可溯源。In order to protect the safety and rights of human subjects,guarantee the quality of clinical trials,and ensure that the data in the clinical trials of drugs were accurate,complete,standardized and traceable; the quality control of the clinical trials of drugs played an important role in the clinical trials of drugs. The whole dynamic management model was applied in the quality control of drug clinical trials and optimized continuously in practice by PDCA,and then three-level quality control system and quantitative quality system were established to ensure that the reported trial data were accurate,complete,and verifiable from source documents.

关 键 词：药物临床试验 儿童 动态管理 质量控制 PDCA循环法 

分 类 号：R969.3[医药卫生—药理学]