Tag: pharmacovigilance causality review

Reconciliation of Investigator and Sponsor Views on AE Causality

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Reconciliation of Investigator and Sponsor Views on AE Causality Reconciling Investigator and Sponsor Views in Causality Assessments Introduction: Why Reconciliation Is Critical In clinical trials, both investigators and sponsors are required to assess whether an adverse event (AE) is related to the investigational product (IP). Investigators provide frontline, patient-level judgments, while sponsors apply a global…

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Adverse Event Reporting and Management, Causality and Severity Assessments

Causality Re-Assessment After Unblinding in Clinical Trials

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Causality Re-Assessment After Unblinding in Clinical Trials Re-Assessing Causality of Adverse Events After Trial Unblinding Introduction: Why Post-Unblinding Reassessment Is Critical Blinded clinical trials are designed to minimize bias by concealing treatment allocation from both investigators and participants. While this methodology strengthens the validity of efficacy outcomes, it presents unique challenges in adverse event (AE)…

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Adverse Event Reporting and Management, Causality and Severity Assessments

Causality Re-Assessment After Unblinding in Clinical Trials

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Causality Re-Assessment After Unblinding in Clinical Trials Re-Assessing Causality of Adverse Events After Trial Unblinding Introduction: Why Causality Must Be Revisited After Unblinding In blinded clinical trials, investigators and sponsors assess adverse event (AE) causality without knowing whether a participant received the investigational product (IP), placebo, or comparator. While this preserves study integrity, it also…

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Adverse Event Reporting and Management, Causality and Severity Assessments

Investigator vs Sponsor Roles in Causality Assessment

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Investigator vs Sponsor Roles in Causality Assessment Understanding Investigator and Sponsor Roles in Causality Assessment Introduction: Why Causality Roles Must Be Defined Causality assessment is central to determining whether an adverse event (AE) is related to an investigational product (IP) in a clinical trial. Both investigators and sponsors play crucial roles in this process, but…

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Adverse Event Reporting and Management, Causality and Severity Assessments