the clinical investigation has been designed to involve as little pain, discomfort, fear and any other foreseeable risk as possible for the subjects, and both the risk threshold and the degree of distress are specifically defined in the clinical investigation plan and constantly monitored;
dearadh an t-imscrúdú cliniciúil chun a laghad pian, míchompord, eagla agus aon riosca eile is féidir a thuar do na hábhair, agus sainítear go sonrach sa phlean maidir le himscrúdú cliniciúil an tairseach riosca agus an méid anacra, agus déantar fiareachán leanúnach orthu;