1
Interpret the signal in context of other relevant sources, disease knowledge, biologic plausibility, alternative etiologies, etc. Detection Prioritization Evaluation Learn more about Oracle’s safety solutions and our services today! Detection Prioritization Evaluation Signal 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
