Application and Efficacy of 6S Quality Management Methods in Drug Clinical Trials of Oncology Department
10.3870/j.issn.1004-0781.2017.08.010
- VernacularTitle:6S质量管理方法在肿瘤科药物临床试验中的应用及效果
- Author:
Li TIAN
;
Aimin LI
;
Hong ZHANG
;
Ying ZHANG
;
Qiaozhi SUN
;
Jinhong MIAO
;
Mingzhi ZHANG
;
Changying CHEN
- Keywords:
6S quality management;
Drug clinical trial;
Sample collection;
Subjects' satisfaction
- From:
Herald of Medicine
2017;36(8):883-887
- CountryChina
- Language:Chinese
-
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.
