the medical care provided to the subjects is the responsibility of an appropriately qualified medical doctor or, where appropriate, a qualified dental practitioner or any other person entitled by national law to provide the relevant patient care under clinical investigation conditions;
maidir leis an gcúram leighis a thugtar do na hábhair, is faoi fhreagracht dochtúir atá cáilithe go hiomchuí a bheidh sé nó, i gcás inarb iomchuí, is faoi chleachtóir déidliachta cáilithe a bheidh sé, nó aon duine eile atá i dteideal, faoin dlí náisiúnta, an cúram othar ábhartha a thabhairt, an cúram sin a thabhairt faoi dhálaí imscrúdaithe chliniciúil;