关键词: 临床试验, 质量管理, PDCA循环, 风险管理, 优化研究

Abstract:

Objective： To explore innovative measures and methods to optimize the clinical trial quality management system， in order to achieve continuous improvement in the quality of clinical trials， safeguard the rights and safety of participants.Methods： Management tools such as brainstorming sessions， fishbone diagrams， and PDCA （Plan-Do-Check-Act） cycles were employed to classify and summarize issues related to clinical trial quality control in a drug clinical trial institution of a municipal-level hospital. The study analyzed root causes of the problem from multiple perspectives including research institutions， researchers，sponsors and subjects. Corresponding systems and intervention strategies were developed focusing on system construction， accountability implementation， capability enhancement， and process management.Results： By optimizing the clinical trial quality management system， the quality of clinical trials in this hospital has significantly improved， and the overal incidence of abnormal problems-such as subject screening errors，safety event management deficiencies， inadequacies in source documentation/data recording practices， and experimental drug management was notably reduced.Conclusion： In light of new policy developments， drug clinical trial institutions should enhance their quality management systems by reinforcing accountability and performance assessments among principal investigators， improving researcher capabilities while standardizing Good Clinical Practice （GCP） evaluations， refining the overall quality control framework and perfecting risk management models， to comprehensively ensure the quality of clinical trials.

Key words: Clinical trials； , Quality management； , PDCA cycle； , Risk management； , Optimization