临床研究协调员参与人类遗传资源管理的探索与实践  

Exploration and Practice of Clinical Research Coordinator Participating in Human Genetic Resource Management

作　　者：蔡雪玲 陈娜[1] 吕丽虹[1] 邹燕琴[1] 戴婕[1] CAI Xueling;CHEN Na;LV Lihong;ZOU Yanqin;DAI Jie(Drug Clinical Trial Institutions,Sun Yat-sen Memorial Hospital,Sun Yat-sen University,Guangzhou,Guangdong 510120,China)

机构地区：[1]中山大学孙逸仙纪念医院国家药物临床试验机构,广东广州510120

出　　处：《今日药学》2023年第10期780-783,788,共5页Pharmacy Today

基　　金：广东省医学科学技术研究基金项目(A2020469)。

摘　　要：目的探讨临床研究协调员(CRC)参与药物临床试验人类遗传资源管理的可行性和必要性,确保研究机构人类遗传资源使用的合法合规。方法对医院CRC进行人类遗传资源管理相关知识调研。通过完善相关管理制度和开展针对问题的专题培训,明确CRC在人类遗传资源管理中的职责并规范研究机构对人类遗传资源的全流程管理。结果CRC在人类遗传资源管理中的意识与责任感有所提高,参与度有所增强。通过对质控问题分析发现,有关人类遗传资源的质控问题得到控制,从源头上确保各项临床试验符合人类遗传资源相关法规要求。结论CRC的参与是人类遗传资源过程管理中不可或缺的环节,同时为机构强化人类遗传资源活动的全过程规范管理提供了思路和方法。OBJECTIVE To explore the feasibility and necessity of clinical research coordinator(CRC)participating in human genetic resources management in drug clinical trials in order to ensure the legitimacy and compliance of human genetic resources utilization in drug clinical trial institution.METHODS The CRCs in hospital were investigated in the field of human genetic resources management.By improving the relevant management system and conducting special training on issues,the responsibilities of CRC in human genetic resources management were clarified and the whole process management of human genetic resources were standardized by our institutions.RESULTS The participation rate of CRC and its consciousness and responsibility in human genetic resources management were enhanced.To analyze the problems of quality control,it was found that the problems related to human genetic resources were controlled,and to ensure that all clinical trials met the laws and regulations of human genetic resources at the source.CONCLUSION CRC's participation is a critical element in human genetic resources management.Meanwhile ideas and methods have been provided for institutions to strengthen the whole process of standardized management of human genetic resources activities.

关 键 词：人类遗传资源 临床试验 临床管理 临床研究协调员 

分 类 号：R969[医药卫生—药理学]