Under E6 →

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

E6(R3) emphasizes building quality into the trial design from the start, rather than relying on retrospective checking. There is a renewed focus on patient well-being,

For the first time, the guideline explicitly addresses digital tools, wearables, and the "chain of custody" for digital data to ensure traceability and reproducibility. Low-risk aspects should not be overburdened with unnecessary

The International Council for Harmonisation (ICH) recently finalized the guideline, which entered into force in July 2025. This update represents a major shift toward digital-first, risk-proportional clinical research.