What is required by ICH E6 Section 5.18.6 regarding monitoring results?

The requirement in ICH E6 Section 5.18.6 emphasizes the importance of having written reports submitted following each trial-site visit by monitors. This practice is critical for ensuring thorough documentation of the monitoring activities and findings during a clinical trial. Written reports provide a detailed and reliable record that can be referenced later for compliance, auditing, and ensuring that any issues identified are addressed appropriately.

By mandating written reports, ICH E6 ensures that the results of monitoring are clearly communicated to all relevant stakeholders, including the study sponsor and the participating sites. This helps to maintain transparency and accountability in the conduct of clinical trials and assists in safeguarding participant safety and data integrity.

Other choices do not align with the guidelines; for example, relying solely on verbal reports would undermine the documentation process, while not documenting only positive results could lead to gaps in the monitoring records. Similarly, stating that monitoring results do not need to be recorded contradicts the fundamental principles of maintaining comprehensive data throughout the trial process.