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SUSAR Reporting to Ethics Committees How to Report SUSARs to Ethics Committees in Clinical Trials Introduction: Why Ethics Committees Need SUSAR Reports Suspected Unexpected Serious Adverse Reactions (SUSARs) are among the most important safety signals in clinical trials. While regulators such as the FDA, EMA, and MHRA require expedited reporting, ethics committees (ECs)—also called Institutional…
Cross-Check of AE Data with Concomitant Medications in Clinical Trials Cross-Checking AE Data with Concomitant Medications in eCRFs Introduction: Why Cross-Checking AE Data Matters Adverse event (AE) documentation cannot be reviewed in isolation. Regulators including the FDA, EMA, and MHRA expect sponsors to cross-check AE entries in electronic case report forms (eCRFs) with concomitant medication…
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Late Signal Detection Reporting in Clinical Development Audits Why Late Signal Detection Reporting Appears in Regulatory Audit Findings Introduction: Importance of Signal Detection in Clinical Development Pharmacovigilance signal detection is a systematic process of identifying new or changing safety issues related to an investigational product. Regulators such as the FDA, EMA, and MHRA mandate continuous…
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Missing SUSAR Documentation Highlighted During Safety Audits Why Missing SUSAR Documentation Remains a Critical Audit Finding Introduction: The Role of SUSAR Documentation in Clinical Trials Suspected Unexpected Serious Adverse Reactions (SUSARs) represent one of the most significant aspects of clinical trial safety oversight. Regulatory agencies such as the FDA, EMA, and MHRA require timely reporting…
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Delayed SAE Reporting as a Common Regulatory Audit Finding Why Delayed SAE Reporting Is a Frequent Regulatory Audit Concern Introduction to SAE Reporting and Its Criticality Serious Adverse Events (SAEs) represent life-threatening or medically significant occurrences in participants during a clinical trial. Regulatory frameworks such as ICH E2A, 21 CFR Part 312.32 (FDA), and EU…
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