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Structuring Adverse Event Reports to E2B(R3)
reporting-adverse-events
maziyarpanahi/openmed
360
This skill structures free-text adverse event narratives into the mandatory ICH E2B(R3) format. It populates critical fields required for regulatory submissions (like FAERS/EudraVigilance), including suspect drugs, reactions (mapped via MedDRA), seriousness criteria, and reaction outcomes. Use it when generating Individual Case Safety Reports (ICSRs) from clinical narratives.
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