Safety reporting is a critical aspect of clinical trial quality, directly impacting patient safety and regulatory compliance. While risk-based quality management (RBQM) provides multiple tools to manage this risk, ensuring these tools operate in a coordinated and effective manner remains challenging. In line with International Council for Harmonisation (ICH) guideline E6(R3), which emphasizes proportionate and integrated risk management, it is essential to assess how safety reporting is identified, monitored, and controlled across RBQM components.
