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ICSR Quality Checklist
Check an individual case safety report before you submit or assess it.
Minimum elements
A report needs all four to be a valid ICSR.
An identifiable patient
An identifiable reporter
A suspected drug
A suspected adverse reaction
Details that make the report assessable
Patient demographics (age, sex, weight)
Relevant medical history
Concomitant medications
Dates that show the temporal relationship (start, stop, onset)
Dechallenge and rechallenge information
Outcome (recovered, recovering, not recovered, fatal, unknown)