AE causality narratives – Clinical Research Made Simple

Documenting Rationale for Causality in Clinical Trials

September 21, 2025

Documenting Rationale for Causality in Clinical Trials How to Document Rationale for Causality in Clinical Trials Introduction: Why Documentation of Causality Matters Determining whether an adverse event (AE) is related to an investigational product (IP) is a cornerstone of clinical trial safety assessment. Equally important is the documentation of the rationale behind that decision. Regulatory…

Adverse Event Reporting and Management, Causality and Severity Assessments

Reconciliation of Investigator and Sponsor Views on AE Causality

September 20, 2025

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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…

Adverse Event Reporting and Management, Causality and Severity Assessments