Reason for Nullification / Amendment

This data element is used to indicate the reason why a previously transmitted ICSR has been completely nullified (e.g. the entire case has been found to be erroneous) or amended (e.g. following an internal review or upon expert advice, items such as the adverse reaction/event, seriousness, seriousness criteria, or causality assessment have been modified). It is important to use identifiers such as those previously entered in C.1.8.1 that are globally unique. The original date reported in C.1.5 should not be changed in an amended report.