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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)

E6(R3) emphasizes building quality into the trial design from the start, rather than relying on retrospective checking. 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,