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Judgment & ambiguity · When to escalate

You're monitoring an ongoing Phase II trial and notice a cluster of the same adverse event across three sites, each individually below the threshold that would trigger a report, but together suggestive. The medical monitor is on leave. What do you do?

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A pooled signal that no single site would flag is exactly the pattern pharmacovigilance exists to catch, so I escalate now — and the medical monitor being on leave doesn't pause a

The full answer: structure, worked example, likely follow-up.

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