Report Nullification / Amendment

This data element is used to indicate whether a previously transmitted ICSR has been completely nullified (deleted) (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). In the case of amendment, it is important to use identifiers such as the previously entered "Sender's (case) Safety Report Unique Identifier" (C.1.1) and "Worldwide Unique Case Identification" (C.1.8) (see C.1.1 exception). If a previously nullified report needs to be resubmitted, a new "Sender's (case) Safety Report Unique Identifier" (C.1.1) and "Worldwide Unique Case Identification" (C.1.8) should be assigned. The original date in C.1.5 should not be changed in an amended or nullified report when no new information has been received from the primary reporter for the case.