临床研究协调员参与的基于风险的闭环式质量控制模式探讨

Discussion of mode of risk-based closed-loop quality control involving clinical research coordinator

根据本院药物临床试验机构实际质量控制管理经验,初步探讨了临床研究协调员(CRC)参与的基于风险的闭环式质控模式。基于风险的质控模式增加了质控效率,闭环式质控使得质控真正能发挥作用, CRC的引入充实了质控团队。该质控模式为药物临床试验机构的质控提供了一种新的途径。

Based on the actual management experience on quality control of drug clinical trial institutions in our hospital,a risk-based closed-loop quality control model with the participation of clinical research coordinator(CRC) was preliminarily discussed in this paper.The risk-based quality control mode increased the efficiency of quality control,the closed-loop quality control made quality control really work,and the introduction of CRC enriched the quality control team.This quality control model provides a new way for the quality control of drug clinical trial institutions.