What is the purpose of monitoring in clinical trials according to ICH E6?

The purpose of monitoring in clinical trials, as outlined by ICH E6, primarily focuses on ensuring compliance with the study protocol and maintaining the integrity and quality of the data collected. This involves systematic oversight of clinical trial processes to verify that the study is conducted in accordance with regulatory requirements and established guidelines.

Monitoring is crucial for several reasons: it helps identify any deviations from the protocol, ensures that the trial adheres to ethical standards, and confirms that participant safety is prioritized. By meticulously reviewing data and processes, monitors play a significant role in ensuring that findings are credible and can be trusted for regulatory submissions and future patient care practices.

While increasing recruitment numbers, evaluating staff competence, and validating marketing strategies may be relevant in the broader context of clinical research, they are not the primary focus of monitoring according to ICH E6 standards. The central goal remains to uphold the quality of trial data and adherence to established protocols, establishing a reliable basis for concluding the study.