any adverse event of a type identified in the clinical investigation plan as being critical to the evaluation of the results of that clinical investigation;
tarlú díobhálach ar bith de chineál a shainaithnítear sa phlean don imscrúdú cliniciúil mar tharlú atá ríthábhachtach maidir le meastóireacht a dhéanamh ar thorthaí an imscrúdaithe chliniciúil sin;