The development and improvement of ethical review of multi-center clinical trial
10.3760/cma.j.issn.1006-1924.2018.01.015
- VernacularTitle:多中心临床试验伦理审查工作的开展及完善
- Author:
Miaomiao YE
1
;
Yuan CHEN
;
Xiaohui XU
;
Yuanhai ZHANG
;
Xueqiong ZHU
Author Information
1. 325027,温州医科大学附属第二医院
- Keywords:
Multi-center clinical trial;
Ethical review committee;
Subjects;
Ethical review
- From:
Chinese Journal of Medical Science Research Management
2018;31(1):69-72
- CountryChina
- Language:Chinese
-
Abstract:
Objective Improve the ethical review models of multi-center clinical trial.Methods Analyze the ethical review models of multi-center clinical trial in China,and summarize advantages and disadvantages of the different methods.Then,clarify the development of ethical review methods of multi-center clinical trial in our hospital.Results Four methods were used to review the multi center clinical trial in China,including independent ethical review,central institutional ethical review,central review made by committee cooperation,collaborative review.Each method has its advantages and disadvantages.Collaborative review about multi-center clinical trial is adopted now in our hospital.Conclusions Using collaborative review model of multi-center clinical trial,the ethical review could achieve timely and uniformly.
