A Structured Methodology to Assess Safety Signal Strength and Inform Causality Assessment.

ABSTRACT: Causality assessment of safety signals observed with medicinal products is a foundational element of pharmacovigilance and regulatory practice, typically performed by a global introspection process. We have developed a novel, structured methodological framework to support the global introspection process for safety signal causality assessment. This Signal Assessment Guide (SAGe) tool was developed by AstraZeneca and is used internally, both to assess safety signal strength and to inform causality decisions related to safety signals. The term 'safety signal' refers to information arising from one or multiple sources, which suggests a new potentially causal association, or a new aspect of a known association, between an intervention and an adverse event. The key concept underlying the SAGe t

SUBMITTER: Sullivan T 

PROVIDER: S-EPMC9334375 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature