中国卒中杂志2017，Vol.12Issue(9)：877-880,4.DOI:10.3969/j.issn.1673-5765.2017.09.026
药物临床试验方法学进展与质量管理规范教学新模式初步研究
Progress of Drug Clinical Trial Methodology and Pilot Study on New Model of Good Clinical Practice Teaching
郑华光 1王伊龙 1李姝雅 1赵性泉 1王春雪 1王拥军1
作者信息
- 1. 首都医科大学附属北京天坛医院神经病学中心
- 折叠
摘要
Abstract
Objective To investigate how to improve good clinical practice (GCP) Guideline in clinical trials and traditional teaching methods. Methods Key Performance Indicators (KPI) for GCP was established by the qualitative method. Online teaching and offline teaching of KPI were used. Continuous quality improvement was carried by complying with the KPI during the monitoring and inspection of clinical trials. GCP rules for pragmatic clinical trial (PCT) were set up and compared with the international regulations. Results KPI for GCP based on the qualitative research was representative and operable, which can help to understand and comply with the GCP guideline. Continuous quality improvement through KPI could be helpful for quality improvement of drug clinical trial. Conclusion The quality of drug clinical trial can be improved by the new teaching method of GCP of establishing the KPIs and continuous quality improvement.关键词
临床试验/质量管理规范/绩效指标/质量改进/教学Key words
Clinical trials/Good Clinical Practice/Performance indicators/Quality improvement/Teaching引用本文复制引用
郑华光,王伊龙,李姝雅,赵性泉,王春雪,王拥军..药物临床试验方法学进展与质量管理规范教学新模式初步研究[J].中国卒中杂志,2017,12(9):877-880,4.
