Discussion on common protocol violation in clinical trials and its prevention and reduction measures
临床试验常见方案违背及预防和减少措施的探讨

摘要

目的 通过挖掘预防和减少方案违背的措施，有效提高临床试验数据的可靠性，提升临床试验项目的整体质量；方法 总结稽查中出现的方案违背，并分析其原因，找到相应的预防和减少方案违背的措施，进一步提升临床试验的质量；结果 通过分析临床试验中的方案违背及其原因，发现多数方案违背可以有效预防和减少，提高临床试验参与各方的依从性就是一种重要的措施；结论 临床试验数据的真实和可靠是保证临床试验质量的关键，通过分析影响数据可靠性的常见方案违背及其原因，提出相应的预防和减少方案违背的措施，临床试验的质量有望得到更好的改善和提升。

Abstract

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.