Tools for Automating PSUR Generation
Manual PSUR preparation involves data collation from multiple sources, signal trend analyses, tabulation, narrative writing, and formatting. Automation improves:
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Safety Reporting and Pharmacovigilance
Key Differences Between PSURs and DSURs in Pharmacovigilance
A PSUR is a report that provides a comprehensive evaluation of the benefit-risk profile of a medicinal product during the post-marketing phase. Governed by ICH E2C(R2), it includes cumulative safety data and is submitted periodically to health authorities such as the EMA and CDSCO (India).
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Using PSURs for Benefit-Risk Evaluation in Pharmacovigilance
Benefit-risk evaluation is a core function of pharmacovigilance that compares the therapeutic benefits of a drug to its associated risks. These assessments are dynamic and evolve over time with new clinical data, adverse event reports, and real-world usage.
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Managing Multiple PSURs Across Regions in Global Pharmacovigilance
PSUR submissions are not uniformly regulated worldwide. Countries follow guidelines issued by the ICH (specifically ICH E2C(R2)), but local adaptations and requirements exist. Key variations include:
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Understanding Adverse Events vs Serious Adverse Events in Clinical Trials
An Adverse Event is any untoward medical occurrence in a patient or clinical trial subject who has been administered a pharmaceutical product, which does not necessarily have a causal relationship with the treatment.
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Timelines for Reporting Adverse Events to Sponsors and IRBs
In a recent sponsor audit, three SAE reports were found to have been submitted 3–5 days late. The issue was traced to staff turnover and unclear handover of safety responsibilities. As a result, the site implemented a GMP SOP checklist for AE timelines and re-trained all coordinators, preventing further breaches.
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Common Mistakes in PSUR Compilation and How to Avoid Them
Signal evaluation is one of the most critical sections of the PSUR. A frequent mistake is presenting vague, incomplete, or unsubstantiated signal narratives. Sponsors may list adverse events without proper evaluation of frequency, severity, causality, or comparison with historical data.
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Source Documentation for Adverse Events in Clinical Trials
According to ICH GCP, source documents are the original records that capture clinical trial data and findings. For adverse events, these may include:
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Auditing PSUR Submissions and Tracking Compliance in Pharmacovigilance
Auditing PSUR processes allows organizations to:
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Common Errors in Adverse Event Reporting and How to Avoid Them
Adverse event reporting errors are often preventable with clear SOPs, training, and vigilant data review. By understanding the most common mistakes and implementing systematic controls, clinical trial teams can improve safety outcomes, meet regulatory expectations, and strengthen the credibility of their research. Make AE compliance a team responsibility to build audit-ready, patient-centric studies.
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