Clarifying the Responsibilities of Drug Clinical Trial Institution and Ethics Committee in China

VernacularTitle:我国药物临床试验机构与伦理委员会的职责界定
Author: Yongchuan CHEN ; Jing YANG
Publication Type:Journal Article
Keywords: Drug clinical trial institution; Ethics committee; Responsibility conflicts; Responsibility clarification
From: China Pharmacy 2015;26(31):4321-4323
CountryChina
Language:Chinese
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.