中国药房2015，Vol.26Issue(31)：4321-4323,3.DOI:10.6039/j.issn.1001-0408.2015.31.01
我国药物临床试验机构与伦理委员会的职责界定
Clarifying the Responsibilities of Drug Clinical Trial Institution and Ethics Committee in China
摘要
Abstract
OBJECTIVE:To clarify the responsibilities of drug clinical trial institution and ethics committee in China,and to provide reference for the improvement of drug clinical trial management. METHODS:The responsibility conflicts between drug clinical trial institution and ethics committee were summarized,and its reasons were analyzed to provide suggestions. RESULTS &CONCLUSIONS:The responsibility conflicts have been found between drug clinical trial institution and ethics committee,mainly manifesting as the essential person who submits protocol is not clear;the responsibilities in multicenter ethics investigation are con-troversial;the management of their track issues are not connected enough. 3 aspects of measures can be adopted,including reach-ing an agreement of responsibility assignment learning from foreign advanced ideas,improving laws and regulations;enhancing the management,promoting the implementation of policy and agreement. So,the responsibilities of drug clinical trial institution and ethics committee can be further clarified to improve the management of drug clinical trial.关键词
药物临床试验机构/伦理委员会/职责冲突/职责界定Key words
Drug clinical trial institution/Ethics committee/Responsibility conflicts/Responsibility clarification分类
医药卫生引用本文复制引用
陈勇川,杨竟..我国药物临床试验机构与伦理委员会的职责界定[J].中国药房,2015,26(31):4321-4323,3.基金项目
国家"重大新药创制"科技重大专项项目(No.2011-ZX09302-005) （No.2011-ZX09302-005）
