Monitoring and oversight are now scaled based on the actual risks of a trial. Low-risk aspects should not be overburdened with unnecessary bureaucracy.
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.
Monitoring and oversight are now scaled based on the actual risks of a trial. Low-risk aspects should not be overburdened with unnecessary bureaucracy.
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) under e6
E6(R3) emphasizes building quality into the trial design from the start, rather than relying on retrospective checking. Monitoring and oversight are now scaled based on