【作者】 王彦荣； 赵靓； 陈然； 李洪敏； 王莹； 孙晓阳； 李佳芮；

【Author】 WANG Yanrong;ZHAO Liang;CHEN Ran;LI Hongmin;WANG Ying;SUN Xiaoyang;LI Jiarui;Cangzhou Central Hospital;Hebei Provincial Pharmaceutical Professional Inspector Corps (Southern District);

【机构】 沧州市中心医院； 河北省药品职业化检查员总队(南片区)；

【摘要】 近年来我国医药产业快速发展,陆续颁布鼓励药品医疗器械创新政策,药物临床试验机构改成备案制管理,大量的临床医务人员加入到临床试验研究者的队伍中来。而主要研究者是实施临床试验的关键主体,是临床试验质量及受试者权益和安全的试验现场负责人。如何培训出责任心强,专业水平高的主要研究者,使其能履行主要研究者的职责并发挥重要的作用,是个值得探讨的问题。结合近年来的实践经验,文章探析了培训新备案主要研究者的举措,以期为药物临床试验机构建立主要研究者的培训与管理体系提供借鉴。更多还原

【Abstract】 In recent years,the rapid development of China’s pharmaceutical industry,continued to issue policies to encourage drug medical device innovation,drug clinical trial institutions into the record system management,a large number of clinical medical personnel to join the team of clinical trial researchers.The principal investigator is the key subject of clinical trials,and the person in charge of the trial site for the quality of clinical trials and the rights and safety of subjects.How to train principal investigator with strong sense of responsibility and high professional level,so that they can fulfill the responsibilities of principal investigator and play an important role,is a problem worth exploring.Combined with the practical experience in recent years,this paper analyzes the measures to train the principal investigator of newly registered clinical trials,in order to provide reference for the establishment of principal investigator training and management system in drug clinical trial institutions.更多还原