7.1 Trial processes should be proportionate to the risks inherent in the trial and the importance of the information collected. Risks in this context include risks to the rights, safety and well-being of trial participants as well as risks to the reliability of the trial results.
7.2 The focus should be on the risks associated with trial participation. For clinical trials involving patients, the focus should be on risks that go beyond those associated with usual medical care.
The risks relating to investigational products that have a marketing authorisation when used in the clinical trial context may differ from the usual care of patients and should be taken into consideration.
7.3 Risks to critical to quality factors should be managed proactively and adjusted when new or unanticipated issues arise once the trial has begun.
7.4 Trial processes should be operationally feasible and avoid unnecessary complexity, procedures and data collection. Trial processes should support the key trial objectives. The sponsor should not place unnecessary burden on participants and investigators.