儿科药学杂志2018，Vol.24Issue(8)：43-45,3.DOI:10.13407/j.cnki.jpp.1672-108X.2018.08.014
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
摘要
Abstract
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Key words
clinical trials/children/dynamic management model/quality control/PDCA分类
医药卫生引用本文复制引用
王婷,张志华,何周康,石绍南..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[J].儿科药学杂志,2018,24(8):43-45,3.基金项目
湖南省儿童医院2017年度院级科研课题,编号6-B. （）
