when it considers that participation in the clinical investigation would lead to a subject receiving treatment inferior to that received in normal clinical practice in that Member State concerned;
nuair a mheastar dó go bhfágfadh rannpháirtíocht in imscrúdú cliniciúil an ábhair le cóireáil ar cháilíocht níos ísle ná na cóireála a fhaightear sa ghnáthchleachtas cliniciúil sa Bhallstát sin lena mbaineann;