2020年版《药物临床试验质量管理规范》研究者和申办者保护受试者的要求  

Requirements for Investigator and Sponsor to Protect Participant from 2020 Version of Good Clinical Practice

作　　者：周吉银 ZHOU Jiyin(National Drug Clinical Trial Institution,the Second Affiliated Hospital of Army Medical University,Chongqing 400037,China)

机构地区：[1]陆军军医大学第二附属医院国家药物临床试验机构,重庆400037

出　　处：《中国医学伦理学》2021年第2期205-210,共6页Chinese Medical Ethics

基　　金：2019年陕西省健康文化研究中心立项资助项目“伦理倾销对我国的危害及防范研究”(JKWH2019-Q07)。

摘　　要：新版《药物临床试验质量管理规范》于2020年7月1日正式实施,大幅度修改后的要求更高,可操作性强,明确和细化各方责任,特别要求强化受试者的保护。除伦理委员会之外,研究者和申办者也是保护受试者的重要角色。研究者要有合格的临床和试验资格,不可预筛受试者,严格知情同意,及时报告安全性信息和避免禁用的合并用药。申办者负责制定试验方案,选择研究者,保障试验用药品,告知受试者揭盲结果,可建立独立的数据监查委员会,分析报告安全性信息等。研究者、申办者应与伦理委员会共同加强受试者的保护,有助于我国药物临床试验与国际接轨,提升其质量。The new edition of Good Clinical Practice was officially implemented on July 1,2020.The revised version requirements have higher requirements,strong operability,and clarifies and refines the self-responsibility of all parties,with special requirements to strengthen the protection of participants after the large-scale modification.In addition to the ethics committee,investigators and sponsors are also important players to protect the Participants.The investigators must have qualified clinical and trial qualifications,cannot pre-screen participants,strictly follow informed consent,timely report safety information,and avoid contraindicated combined medication.The sponsors are responsible for formulating the trial protocol,selecting the investigators,guaranteeing the clinical trial drug,informing participants of the blindness results,establishing an independent data monitoring committee,and analyzing and reporting safety information.Investigators and sponsors should work together with the ethics committee to strengthen the protection of participants,which will help improve the quality of China's drug clinical trials and be in line with international standards.

关 键 词：药物临床试验质量管理规范 研究者 申办者 受试者 

分 类 号：R-052[医药卫生]