监查员在药物临床试验质量控制中具有重要作用。目前监查员管理中还存在不少问题，监查员在药物临床试验质量控制中的作用未能充分发挥。因此，应加强对监查员工作重要性的认识，建立切实可行的监查员管理制度，稳定监查员队伍，以发挥监查员的作用，保证药物临床试验的质量。

Monitors play an important role in the quality control of drug clinical trials，but there are still many problems in the current monitors management which results into monitors failing in fully playing their roles. Therefore，awareness of the importance of monitors position，establishment of practical management system and stabilization of the monitors team should be emphasized to effectively play the role of monitors and ensure the quality of clinical trials.

R285.6

科技部“十二五”重大新药创制项目:创新药物研究开发技术平台建设(2012ZX09303009-001)；上海市中医药事业发展3年行动计划项目(ZYSNXD-CC-YJXYY)。