基于HACCP理论的临床试验质量控制体系探索OA

Objective To further optimize the clinical trial quality control system.Methods Based on the hazard analysis and Critical Control Point(HACCP)theory,a team was established.After discussion,the key points of the quality management system were preliminarily identified,and two rounds of Delphi method were conducted to clarify the scope,objectives,and progress of HACCP.The team discussion summarized six processes for clinical trial quality management,and critical control points(CCPs)in the clinical trial management process were identified through hazard analysis(HA),and a closed-loop management path for clinical trials was explored.Results Nine CCPs in the clinical trial management process were identified,and mechanisms for pre-event prevention,in-event monitoring,and post-event intervention were established accordingly.By formulating monitoring requirements,corrective measures,and verification procedures for CCPs,a closed-loop management for clinical trials was achieved.Conclusion This study established a prevention-oriented clinical trial quality control system,which can partly prevent and reduce the occurrence of clinical trial quality control incidents,and is of great significance for improving the quality and standardization of clinical trials.