[ SCENARIO · FREE · DETERMINISTIC ]
Signal to Action
A report of harm reaches your company by an unexpected route. Decide how it is captured, assessed, reported and escalated — and what to do when the evidence is suggestive but not conclusive.
What a scenario is not
A scenario is a judgment exercise, not an assessment and not a compliance verdict. Finishing it evidences that you worked through it — nothing more — and the dimensions it scores are SPEQ’s, not any regulator’s.
Someone reports that a medicine may have harmed a patient. You decide what happens next, and how quickly.
Under Good Pharmacovigilance Practices the reporting clock runs from the organisation’s first awareness by anyone, individual cases feed signal detection, and a signal is evaluated on the evidence rather than on how inconvenient it is.
Pharmacovigilance fails quietly. Nothing visibly breaks when a case is captured late or a weak signal is set aside — the cost lands on patients who were prescribed the medicine while the question stayed open.
You work in pharmacovigilance for a marketing authorisation holder. A sales colleague forwards you an email from a physician describing a serious reaction.
Each decision changes what arrives next. Choose what a system in control would actually do.
The email came to a sales representative four days ago and reached you today. It describes a serious, unlisted reaction in a named patient. What do you do first?
This is a judgment exercise, not a quiz: your choices change the situation. It is scored across timeliness · assessment · governance · evidence — the same dimensions an inspector effectively weighs when they follow the thread of a real deviation. There is no compliance verdict here; the debriefs explain consequences.
WHAT THE CORRECT PATH RESTS ON
The primary sources behind the debriefs. The authoritative text lives at each official source.
Finishing this exercise is recorded. What it evidences — and the things it does not — is set out against the published standard.
What this evidences →DO IT FOR REAL
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