摘要
目的:推动中国药物临床试验伦理委员会的建设和发展。方法:回顾性分析药物临床试验伦理委员会在管理与审查中存在的问题,并提出相应的解决方法。结果和结论:随着卫生主管部门、机构、研究者以及申办者等对伦理审查工作的重视,药物临床试验伦理委员会的建设将会取得快速发展。
Objective： To promote the development of Institutional Review Board （1RB） for drug clinical trial. Methods： Retrospectively analyse the common problems in the management and the practice of IRB, and give some solutions to the problems. Results and Conclusion＂ With more and more attention be paid to the IRB management by the Government, Institution, Investigators, as well as the sponsor and other stakeholders, the greater progress of the IRB for drug clinical trial in China will be achieved in the near future.
出处
《药品评价》
CAS
2011年第4期4-8,共5页
Drug Evaluation
关键词
药物临床试验
伦理委员会
管理
伦理审查
展望
Drug clinical trial
Institutional Review Board （IRB）
Management
Ethical reviewing
Prospects
