摘要
建立和完善药物临床试验机构的质量控制(质控)体系,是保障临床试验质量的关键。近年药物临床试验数量持续提升,质控要求不断提高。而在临床工作中,医疗人员的工作负荷大,投入到临床试验的精力有限。临床研究协调员(clinical research coordinator,CRC)作为临床试验的参与者和协调者,在研究者的授权和指导下,进行了非医学性判断的相关事务性工作,也在临床试验中承担着许多具体工作。该文根据四川大学华西医院院内CRC及医院药物临床试验机构质控管理经验,探讨了院内CRC参与临床试验质控的模式。院内CRC通过参与临床试验的质控,不仅提高了质控效率,充实了质控队伍,也提升了CRC的整体水平。该种模式丰富了药物临床试验的质控体系。
Establishing and improving the quality control system of drug clinical trial institutions is the key to ensure the quality of clinical trial.In recent years,the number of drug clinical trial has been continuously improved,and the quality control requirements have been continuously improved.However,in clinical work,the workload of medical staff is heavy,and the energy devoted to clinical trial is limited.Clinical research coordinator(CRC),as a participant and coordinator of clinical trial,has carried out transactional work related to non-medical judgment under the authorization and guidance of researchers,and has undertaken any specific work in clinical trial.Based on the quality control management experience of nosocomial CRC and hospital drug clinical trial institutions in West China Hospital of Sichuan University,this paper discusses the mode of nosocomial CRC participating in clinical trial quality control.By participating in the quality control of clinical trial,the nosocomial CRC has improved the quality control efficiency,enriched the quality control team and improved the overall level of CRC.This model enriches the quality control system of drug clinical trial.
作者
朱和莲
高秋悦
向瑾
ZHU Helian;GAO Qiuyue;XIANG Jin(Chengdu West China Clinical Research Center Co.,Ltd,Chengdu,Sichuan 610041,P.R.China;Clinical Trail Center,West China Hospital,Sichuan University,Chengdu,Sichuan 610041,P.R.China)
出处
《华西医学》
CAS
2022年第1期97-101,共5页
West China Medical Journal
基金
国家科技重大专项(2018ZX09201018-020)。
关键词
临床研究协调员
药物临床试验
质量控制
Clinical research coordinator
drug clinical trial
quality control
