Application and Efficacy of 6S Quality Management Methods in Drug Clinical Trials of Oncology Department / 医药导报

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.