CAJ | 학술논문

本文通过从申办者、受试者、研究者三个不同角度对研究工作贡献的考量指标等内容分析临床监查员在临床试验中的工作职责，总结出临床监查员在临床研究试验中主要承担试验机构筛选、研究者会议组织、协助制定试验文件、知情同意书和病例报告表核查、不良事件上报、研究资料存档等重要工作。同时分析了影响临床监查员职能发挥的因素，提示临床监查员对于临床试验意义重大，应该给予足够的重视和关注。建设高质量的临床监查员队伍，可以提供优质高效的服务，促进国内临床试验和医疗水平的发展。
본문통과종신판자、수시자、연구자삼개불동각도대연구공작공헌적고량지표등내용분석림상감사원재림상시험중적공작직책，총결출림상감사원재림상연구시험중주요승담시험궤구사선、연구자회의조직、협조제정시험문건、지정동의서화병례보고표핵사、불량사건상보、연구자료존당등중요공작。동시분석료영향림상감사원직능발휘적인소，제시림상감사원대우림상시험의의중대，응해급여족구적중시화관주。건설고질량적림상감사원대오，가이제공우질고효적복무，촉진국내림상시험화의료수평적발전。
This paper analyzed clinical arbitrator responsibility in clinical trials from three different angles of the sponsor,the subjects,the researchers.clinical examiner mainly undertake important tasks such as the screening test institutions,researchers conference organization and assist in developing test case files,informed consent,and report verification,adverse event reporting, research data archive and so on.At the same time analyzed the factors influencing clinical arbitrator function display,prompted clinical arbitrator is of great significance for clinical trials,should give enough attention and concern.Construction of high quality clinical examiner team can provide quality and efficient services,promote the development of domestic clinical trials and health level.