摘要
目的为探索药物临床试验机构对临床研究协调员(clinical research coordinator,CRC)/现场管理组织(site management organization,SMO)进行规范化管理提供思路。方法CRC/SMO管理体系包含评估体系、培训体系、奖罚体系3大模块。结果通过3大体系的建设与实施,完善了CRC/SMO的管理,医疗安全得到保证,临床试验的质量也有所提高并在实践中不断完善,形成相对成熟的管理模式。结论CRC是确保药物临床试验质量非常重要的一环,通过构建CRC/SMO管理体系可以提高CRC专业技能水平,强化CRC责任意识,提高药物临床试验质量。
OBJECTIVE To provide a theoretical basis for how to standardize the management of clinical research coordinator(CRC)/site management organization(SMO)in drug clinical trial institution.METHODS CRC/SMO management system included three modules,which were composed of evaluation system,training system and reward and punishment system.RESULTS Through the construction and implementation of the three systems,the management of CRC/SMO had been improved,the medical safety had been guaranteed,the quality of clinical trials had also been improved and constantly improved in practice,forming a relatively mature management mode.CONCLUSION CRC plays an important role in ensuring the quality of drug clinical trials.Through the construction of CRC/SMO management system,the professional level of CRC should be significantly improved,the sense of responsibility of CRC should be strengthened,in order to improve the quality of drug clinical trials.
作者
邹燕琴
陈娜
吕丽虹
戴婕
沈杰
ZOU Yanqin;CHEN Na;LV Lihong;DAI Jie;SHEN Jie(Drug Clinical Trial Institutions,Sun Yat-sen Memorial Hospital,Sun Yat-sen University,Guangzhou,Guangdong 510120,China)
出处
《今日药学》
CAS
2023年第1期77-80,共4页
Pharmacy Today
基金
广东省医学科学技术研究基金项目(A2020469)。
关键词
临床研究协调员
现场管理组织
药物临床试验质量
管理体系
clinical research coordinator
site management organization
quality of drug clinical trial
management system