According to ICH E6, how should risks be managed throughout the trial process?

The correct approach according to ICH E6 is to manage risks by assessing and prioritizing based on significance. This means that during a clinical trial, it is essential to identify potential risks and evaluate them to determine their likelihood and impact on the study's objectives and participant safety. By prioritizing risks based on their significance, trial sponsors and investigators can allocate resources effectively to manage the most critical risks, ensuring that participant welfare is safeguarded while facilitating the successful completion of the trial. This risk-based approach is a fundamental aspect of Good Clinical Practice, as it promotes a balanced perspective on risk management that allows for informed decision-making throughout the trial process.