Signal

the detailed process proposed by:

Detection Prioritization Evaluation

Council for International Organizations of Medical Sciences (CIOMS) Working Group VIII

Individual Case Safety Reports

Clinical Trials Post-marketing Surveillance Literature Reviews

Detection

Signal Detection

Company Databases Monitoring Systems

Traditional PV Methods

Individual Case Review Aggregate Analysis Periodic Reports

Data Mining Algorithms

Disproportional Reporting Ratios

Triage of Outputs

Interpret the signal in context of other relevant sources, disease knowledge, biologic plausibility, alternative etiologies, etc.

Prioritization

Additional Monitored Data

Non-interventional Studies Non-clinical Studies Class Analysis Other Relevant Information

Need Further Investigation?

Yes
Impact Assessment and Prioritization

No
Is Signal Refuted?

Yes
Close Out

No
Monitor if Signal is

Indeterminate

Evaluation

Signal Evaluation

Individual Case Review Aggregate Analysis Periodic Reports Non-interventional Studies Non-clinical Studies Class Analysis Other Relevant Information

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