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Individual Case Safety Report (Adverse Event Report) - PORR_RM040001HT01 Contents Previous Next Conformance Examples 4.13 Individual Case Safety Report (Adverse Event Report) - PORR_RM040001HT01 This section contains the following topics: 4.13.1 Introduction 4.13.2 RMIM 4.13.3 State Transitions/Trigger Events 4.13.4 Interactions 4.13.5 Referenced CMETs 4.13.6 Links to Artifacts 4.13.1 Introduction The Individual Case Safety Report (Adverse Event Report) RMIM captures the information needed to support messaging adverse events, potential adverse events and product problems to regulators
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