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

1. Signal
Detection
Prioritization
Evaluation
the detailed process proposed by:
Council for International Organizations of Medical Sciences (CIOMS)
Working Group VIII
 Clinical Trials
Individual  Post-marketing Surveillance
 Literature Reviews
Case Safety
Reports
Detection
 Company Databases
 Monitoring Systems
Signal
Detection
 Individual Case Review  Disproportional
Traditional  Aggregate Analysis Data Reporting Ratios
PV  Periodic Reports
Mining
Methods Algorithms
 Interpret the signal in context
of other relevant sources,
Triage of disease knowledge, biologic
Outputs plausibility, alternative
etiologies, etc.
 Non-interventional Studies
Additional  Non-clinical Studies Need
Class Analysis
Further

Monitored  Other Relevant Information
Data Investigation?
Prioritization
Yes No
Impact
Assessment
Is Signal
and
Refuted?
Prioritization
Yes No
Monitor if
Close Out Signal is
Indeterminate
Evaluation
 Individual Case Review
 Aggregate Analysis
Signal  Periodic Reports
 Non-interventional Studies
Evaluation  Non-clinical Studies
 Class Analysis
 Other Relevant Information
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