What approach does the new ICH E6(R2) required risk management systems emphasize?

The new ICH E6(R2) guidelines place a strong emphasis on a risk-based approach to clinical trial management. This involves identifying potential risks associated with the conduct of clinical trials, which enables sponsors and investigators to assess which risks are critical to the study's objectives and outcomes. By identifying these risks, teams can focus their monitoring efforts on mitigating significant risks while allowing for a more efficient allocation of resources.

This approach promotes a more strategic oversight of the clinical trial operations, allowing for the distinction between risks that must be closely monitored and those that can be managed with less stringent oversight. Consequently, this helps improve the integrity and safety of clinical trials by ensuring that the most significant risks are addressed effectively, enhancing the overall quality of the study outcomes.