构建药物临床试验机构CRC管理体系

Construction of Clinical Research Coordinator Management System for Drug Clinical Trial Institution

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.