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Pharmacovigilance Signal Detection Process

Signal Detection Prioritization Evaluation the detailed process proposed by: Council for International Organizations of Medical Sciences (CIOMS) Working Group VII Clinical Trials Individual Case Safety Reports - Post-marketing Surveillance Literature Reviews Company Databases Monitoring Systems Signal Detection Traditional PV - Individual Case Review Aggregate Analysis · Periodic Reports Disproportional Reporting Ratios Data Mining Algorithms Methods Triage of Outputs Interpret the signal in context of other relevant sources, disease knowledge, biologic plausibility, alternative etiologies, etc. Non-interventional Studies Additional Monitored - Non-clinical Studies Class Analysis - Other Relevant Information Need Further Data Investigation? Yes No Impact Assessment Is Signal Refuted? and Prioritization Yes No Monitor if Signal is Indeterminate Close Out - Individual Case Review Aggregate Analysis · Periodic Reports Signal Evaluation Non-interventional Studies - Non-clinical Studies · Class Analysis - Other Relevant Information Learn more about Oracle 's safety solutions and our services today! ABIOPHARM systemš Gold ORACLE Partner Partner with an Expert www.biopharm.com [email protected] +1 877 654 0033 (US.) +44 (0) 1865 910200 (U.K.) Evaluation Prioritization Detection Signal Detection Prioritization Evaluation the detailed process proposed by: Council for International Organizations of Medical Sciences (CIOMS) Working Group VII Clinical Trials Individual Case Safety Reports - Post-marketing Surveillance Literature Reviews Company Databases Monitoring Systems Signal Detection Traditional PV - Individual Case Review Aggregate Analysis · Periodic Reports Disproportional Reporting Ratios Data Mining Algorithms Methods Triage of Outputs Interpret the signal in context of other relevant sources, disease knowledge, biologic plausibility, alternative etiologies, etc. Non-interventional Studies Additional Monitored - Non-clinical Studies Class Analysis - Other Relevant Information Need Further Data Investigation? Yes No Impact Assessment Is Signal Refuted? and Prioritization Yes No Monitor if Signal is Indeterminate Close Out - Individual Case Review Aggregate Analysis · Periodic Reports Signal Evaluation Non-interventional Studies - Non-clinical Studies · Class Analysis - Other Relevant Information Learn more about Oracle 's safety solutions and our services today! ABIOPHARM systemš Gold ORACLE Partner Partner with an Expert www.biopharm.com [email protected] +1 877 654 0033 (US.) +44 (0) 1865 910200 (U.K.) Evaluation Prioritization Detection

Pharmacovigilance Signal Detection Process

shared by BioPharmSystems on Feb 01
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This infographic details the signal detection process proposed by CIOMS Working Group VIII.

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