Interpret the signal in context of other relevant sources, disease knowledge, biologic plausibility, alternative etiologies, etc.
Det
ectio
nPr
iorit
izat
ion
Eval
uatio
n
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DetectionPrioritizationEvaluationSignal
the detailed process proposed by:Council for International Organizations of Medical Sciences (CIOMS) Working Group VIII
NeedFurther
Investigation?
Yes No
Yes No
Is SignalRefuted?
Close OutMonitor ifSignal is
Indeterminate
Individual Case Review Aggregate Analysis Periodic Reports Non-interventional Studies Non-clinical Studies Class Analysis Other Relevant Information
Clinical Trials Post-marketing Surveillance Literature Reviews
Non-interventional Studies Non-clinical Studies Class Analysis Other Relevant Information
Company Databases Monitoring Systems
Individual Case Review Aggregate Analysis Periodic Reports
Disproportional Reporting Ratios
ImpactAssessment
andPrioritization
Individual Case Safety
Reports
Signal Detection
TraditionalPV
Methods
DataMining
Algorithms
Triage ofOutputs
Additional Monitored
Data
SignalEvaluation
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