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Ethics & accountability · Calling out concerns to leadership

During a pre-launch push, you notice a pattern of adverse-event reports from a trial site that hasn't been fully worked up, and leadership wants to keep the submission timeline. How do you escalate?

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A possible safety signal is not something you time around a launch — the duty to characterize it is independent of the calendar.

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

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