Abstract:Purpose：To explore the feasibility of applying the PDCA management model to quality management in clinical trials and to promote the continuous improvement of quality management in the clinical trials. Methods：The PDCA management method is adopted to improve the trial’squality. A quality control plan is developed at the initiation of the project. During the implementation process，the clinical trial behaviors of the investigators are regulated，and the quality of the trial is checked in different phases. Problems identified before are rectified and made to be the highlights of quality control in the next PDCA management cycle until they are eliminated. Results：The PDCA cycle is successfully introduced into the quality management in clinical trials，which can effectively monitor the quality and achieve the goals of high-quality trials. Conclusion：Through the implementation of the PDCA quality management model，the quality of clinical trials has been effectively improved.