中国食品药品监管Issue(6)：76-83,8.DOI:10.3969/j.issn.1673-5390.2025.06.010
非惩罚性管理和CAPA在药物临床试验质量管理中的应用
The Application of Non-Punitive Management and CAPA in Drug Clinical Trial Quality Management
蒋向明 1赵同香 1徐勍 2马丽萍1
作者信息
- 1. 北京大学首钢医院临床研究机构办公室
- 2. 首颐医疗健康投资管理有限公司
- 折叠
摘要
Abstract
Objective:To explore the effectiveness of non-punitive management and Corrective and Preventive Actions(CAPA)in the continuous improvement of drug clinical trial quality.Methods:Non-punitive management and CAPA were applied in the rectification of a clinical trial medication error.Root cause analysis was conducted,corrective actions were developed,and outcomes were monitored.Results:This approach guarantees timely reporting of medication errors,ensures the scientific and rational formulation of corrective measures,improves rectification efficiency,and effectively prevents recurrence of similar issues.Conclusion:A non-punitive management approach improves the willingness to report adverse events and helps build trust between the clinical research office and clinical departments.The application of CAPA standardizes the correction process,promotes timely and effective problem resolution,improves the efficiency and quality of rectification,and supports both subject safety and the ongoing optimization of the institutional management system.关键词
临床试验/质量管理/非惩罚性管理/纠正预防措施/风险评估Key words
clinical trial/quality management/non-punitive management/corrective and preventive actions(CAPA)/risk assessment分类
医药卫生引用本文复制引用
蒋向明,赵同香,徐勍,马丽萍..非惩罚性管理和CAPA在药物临床试验质量管理中的应用[J].中国食品药品监管,2025,(6):76-83,8.
