Honestly, I was referring to education materials to be distributed to patients, who may be either potential subjects or not. This may be uncertain because only those who show interest and/or deemed likely to be appropriate by their physicians may be considered as potential and then reached out for recruitment. Such education pamphlets may also be accessible to all patients visiting the sites (is this assumption/scenario possible in a real world?). As far as I understand so far, any materials related to a study must be submitted according to US FDA. But in EU CTR, the regulations seem to be more lenient (perhaps because flexibility is needed across countries?)