【摘要】 目的探讨6S质量管理方法在肿瘤科药物临床试验中的应用及效果。方法运用6S质量管理方法,从整理、整顿、清扫、清洁、素养、安全6个方面对肿瘤科研究者的《药物临床试验管理规范》(GCP)知识掌握、标本采集、药物管理等进行质量控制,评价质量管理后的效果。结果实施6S质量管理改进后,医护人员GCP证书的获得率上升至77.80%,标本采集的准确率和试验药物的正确配制率均上升至100.00%,研究方案再学习率达100.00%,受试者的满意度明显上升。结论实施6S质量管理方法能有效提升肿瘤科药物临床试验的质量。更多还原

【Abstract】 Objective To evaluate the application and efficacy of 6S quality management methods in drug clinical trials of oncology department. Methods By using 6S( Seiri,Seiton,Seiso,Seiketsu,Shitsuke,Safety) quality management methods,quality about mastering level of good clinical practice( GCP) knowledge,sample collection and drug management etc. were controlled,and efficacy after the quality control was evaluated. Results After implemention of 6S quality management,rate of achieving GCP certificate was increased to 77.80%,accuracy rate of sample collection and accuracy rate of medicine preparation were increased to 100.00%,and the rate of relearning study protocol was increased to 100. 00%,and subjects’ satisfaction was improved significantly. Conclusion The implementation of 6S quality management methods could effectively enhance the quality of drug clinical trials in oncology department.更多还原