Under E6 May 2026

There is a renewed focus on patient well-being, including expanded transparency in informed consent (e.g., explaining what happens to data if a participant withdraws). 2. OfS Condition E6: Higher Education Safety Quality by Design in Clinical Trials under ICH E6(R3)

Monitoring and oversight are now scaled based on the actual risks of a trial. Low-risk aspects should not be overburdened with unnecessary bureaucracy. under e6

For the first time, the guideline explicitly addresses digital tools, wearables, and the "chain of custody" for digital data to ensure traceability and reproducibility. There is a renewed focus on patient well-being,