ICH E6(R3) - Good Clinical Practice P7: Keep processes proportionate to risks to participants and the importance of the data, focus on risks beyond usual care, manage risks to critical factors proactively and avoid unnecessary complexity and burden

What does P7 require?

Trial processes and measures should be proportionate to the trial's risks and to how important the collected information is, risks covering both participant protection and reliability of results. Attention should go to risks of trial participation, for patients those beyond usual medical care, recognising that authorised products used in a trial may carry risks different from routine care. Risks to the critical to quality factors need managing ahead of time and revisited as new issues emerge, and processes should be operationally feasible, avoid unnecessary procedures and data, support key objectives and not burden participants or investigators needlessly.