How should trial-related decisions be assessed according to ICH E6(R3)?

• A. Only during regulatory inspections.
• B. Decisions should be assessed for impact on participant rights, safety, well-being, and reliability of trial results, with risks managed throughout the trial.
• C. Only financial impact.
• D. Only data integrity.

Answer: (B)

The main idea is that every trial-related decision should be evaluated for its potential impact on participant rights, safety, and well-being, as well as the reliability of the trial results, with risks managed throughout the trial. This reflects ICH E6(R3)’s emphasis on ongoing, risk-based decision making, where new information prompts adjustments to safeguards, monitoring, or conduct to protect participants and data quality. It’s broader than any single aspect like inspections, finances, or data integrity alone. By continuously assessing risks and their effects, the trial remains aligned with participant protection and the trustworthiness of results.