regarding incapacitated subjects and minors, the informed consent shall be sought by the investigator from his or her legally designated representative without undue delay and the information referred to in Article 29(2) shall be given as soon as possible to the subject and to his or her legally designated representative;
Le promoteur notifie à chaque État membre concerné le début d'un essai clinique en rapport avec ledit État membre par l'intermédiaire du portail de l'Union.