临床研究协调员对药物临床试验的影响

Influence of clinical research coordinator in the clinical trials

临床研究协调员(CRC)受到国内药物临床试验机构及药物申办者的广泛关注,在临床试验中所扮演的角色越来越重要。CRC是临床研究者、申办者与受试者之间的纽带,在药物临床试验过程中起协调及管理作用,通过CRC的参与协调,保证了受试者入组进度及项目的顺利进行,同时提高了研究质量。简要介绍新药临床试验过程中,CRC的运行机制和具体工作职责,为各药物临床试验机构的建设和管理及药物临床试验的质量提高提供参考。

At present,clinical trials coordinators are concerned widely by domestic drug clinical trial institutions and sponsors,because they play an increasingly important role in clinical trials. Clinical research coordinator (CRC) is the link in clinical investigators,sponsors and subjects. They play a vital role in coordinating and management in drug clinical trials process. They ensure the smooth progress into the group of subjects and projects,and improve the quality of research. Therefore we introduced the operation mechanism of CRC that could be beneficial to improve the quality of GCP in China.