any adverse event of a type identified in the performance study plan as being critical to the evaluation of the results of that performance study;
aon tarlú díobhálach de chineál a sainaithníodh sa phlean don staidéar feidhmíochta mar ríthábhachtach maidir leis an meastóireacht ar thorthaí an staidéir feidhmíochta sin;