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Common Issues Identified in EDC Audit Logs Frequent Pitfalls in EDC Audit Logs and How to Resolve Them Why EDC Audit Logs Face Close Scrutiny in Inspections Electronic Data Capture (EDC) systems have revolutionized clinical trial data management, offering real-time access, automation, and traceability. However, with this digital advancement comes the critical responsibility of maintaining…
Surveillance of Rare Adverse Events Post-Vaccination Surveillance of Rare Adverse Events Post-Vaccination Why rare-event surveillance matters—and what a regulator expects to see Licensure is not the end of safety work; it marks the start of population-scale learning. Pre-licensure studies are typically underpowered for events occurring at 1–10 per million doses (e.g., anaphylaxis, myocarditis, thrombosis with…
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