E. Information research subjects
To inform potential subjects, all study-specific information must be submitted. This includes, but is not limited to, information sheets with consent forms, advertising and recruitment texts, study brochures, patient diaries and questionnaires. General information not specifically drawn up for the study need not be submitted for review. This concerns, for example, brochures with information about standard treatment, general instructions for use of an app or device, privacy policy of a website, travel organisation or other parties, claim forms, welcome or thank you notes, et cetera.