Who is a minor participating in a paediatric clinical trial?
The legal definition of a minor may differ according to Member States legislations. It generally refers to a person who has not reached the legal age of adulthood (usually 18 and above, rarely 16). In the Clinical Trials Directive (Dir. 20/2001/EC) we find both the terms children and minors, while in the ICH E11 guideline (ICH Topic E11, 2000) the paediatric population is defined according to different age categories from birth up to 16-18 years (dependent on region).
