International Medical Research Frontier

Objective By digging measures to prevent and reduce protocol violations，the reliability of clinical trial data can be effectively improved and the overall quality of clinical trial projects can be improved; Methods Summarize the protocol violation in the inspection, analyze its reasons, find the corresponding measures to prevent and reduce the protocol violation, and further improve the quality of clinical trials; Results By analyzing the protocol violations in clinical trials and their causes, it is found that most protocol violations can be effectively prevented and reduced, and improving the compliance of all parties involved in clinical trials is an important measure. Conclusion The authenticity and reliability of clinical trial data is the key to ensure the quality of clinical trials. By analyzing the common protocol violations that affect the reliability of data and their causes, the corresponding measures to prevent and reduce protocol violations are put forward, and the quality of clinical trials is expected to be better improved and promoted.

Clinical trials; Protocol violation; Cause analysis; Preventive measures; Reduction measures