all suspected unexpected serious adverse reactions to investigational medicinal products occurring in that clinical trial, irrespective of whether the suspected unexpected serious adverse reaction has occurred at a clinical trial site in the Union or in a third country;
Si nécessaire, afin de respecter les délais de notification, le promoteur peut transmettre un premier rapport incomplet suivi d'un rapport complet, conformément à la section 2.4 de l'annexe III.