The Continuous Improvement Practice of Ethics Quality Management in Drug Clinical Trial
- VernacularTitle:药物临床试验伦理质量管理持续改进实践
- Author:
Min WU
;
Jinglong GAO
- Publication Type:Journal Article
- Keywords:
Research Ethics;
Quality Management;
Drug Clinical Trial;
Ethical Review
- From:
Chinese Medical Ethics
2015;(5):769-771
- CountryChina
- Language:Chinese
-
Abstract:
The authors through the analysis on the state food and drug administration for clinical drug agency qualification , the ethics committee to run the problem:ethics committee incomplete management system and SOP;Familiar with work system and review process to be;Track review is not standard;Pilot project information manage-ment confusion;Ethics committee hardware substandard housing .And puts forward the following measures to solve these problems , reasonable adjustment of organization structure , strengthen the system construction , standard re-view process , establish 3 levels training model and improve office conditions .
