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