Objective: To strengthen the supervision of drug clinical trial institution on the performance of the clinical research coordinator (CRC)

so as to better control the quality of clinical trials. Methods: Before the responsibilities of CRC were authorized by principal investigator (PI)

the qualifications of CRC would be reviewed

and the CRC would be trained and assessed on the relevant knowledge such as the clinical trial protocol

Good Clinical Practice (GCP)

the institutional Standard Operating Procedures (SOP) and management system. After the responsibilities of CRC were authorized by PI

the quantitative supervision of CRC work was carried out

and the black and white list management for CRC or site management organization (SMO) were performed. Results: The most of CRC could effectively perform its duties and improve the quality of clinical trials

yet the CRC had the large mobility

which indirectly increased the workload of drug clinical trial institution. Conclusion: The drug clinical trial institution of our hospital has a good promotion and application value for the supervision mode of CRC

yet it still needs to optimize the supervision mode of CRC.