Objective: To explore the role of PDCA cycle in the qualification of drug clinical trial institutions in Xuzhou Children’s Hospital

Xuzhou Medical University. Methods: Based on the theory of PDCA cycle

the existing problems in the qualification of drug clinical trial institutions of our hospital were analyzed

relevant countermeasures for hardware construction

personnel training and system construction were formulated

and continuous improvements were performed. Results: Through PDCA cycle

our hospital achieved significant results in the qualification. And the office of the institution

the ethics committee and the 10 majors had all passed the qualification. Conclusion: The application of PDCA cycle has played a positive role in the qualification of drug clinical trial institutions in our hospital