Signal Detection in Pharmacovigilance - Process proposed by CIOMS Working Group VIII

Signal Detection in Pharmacovigilance - Process proposed by CIOMS Working Group VIII

1.  Interpret the signal in context
of other relevant sources,
disease knowledge, biologic
plausibility, alternative
etiologies, etc.
Detection Prioritization Evaluation
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Detection
Prioritization
EvaluationSignal
the detailed process proposed by:
Council for International Organizations of Medical Sciences (CIOMS)
Working Group VIII
Need
Further
Investigation?
Yes No
Yes No
Is Signal
Refuted?
Close Out
Monitor if
Signal 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
Impact
Assessment
and
Prioritization
Individual
Case Safety
Reports
Signal
Detection
Traditional
PV
Methods
Data
Mining
Algorithms
Triage of
Outputs
Additional
Monitored
Data
Signal
Evaluation