Tag: SUSAR reporting compliance

Global Variability in SUSAR Definitions

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Global Variability in SUSAR Definitions Understanding Global Variability in SUSAR Definitions Introduction: Why SUSAR Definitions Differ Across the Globe Suspected Unexpected Serious Adverse Reactions (SUSARs) are a cornerstone of pharmacovigilance in clinical trials. Yet, despite harmonization attempts under ICH E2A and CIOMS, definitions and interpretations of SUSARs vary significantly across regulatory regions. This variability creates…

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Adverse Event Reporting and Management, Regulatory Reporting Requirements (CIOMS, SUSARs)

What is a SUSAR and When to Report It?

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What is a SUSAR and When to Report It? Understanding SUSARs and Their Reporting Requirements in Clinical Trials Introduction: Why SUSARs Matter in Clinical Trials In global clinical research, adverse event (AE) reporting is central to ensuring participant safety and regulatory compliance. Among the categories of AEs, one of the most critical is the Suspected…

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Adverse Event Reporting and Management, Regulatory Reporting Requirements (CIOMS, SUSARs)