What does the term 'Expectedness' refer to in the context of an ADR?

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Multiple Choice

What does the term 'Expectedness' refer to in the context of an ADR?

Explanation:
Expectedness in adverse drug reaction reporting means determining whether the reaction is already described in the drug’s reference safety information, specifically the labeling or the Investigator’s Brochure. If an ADR is listed there, it’s considered expected; if it isn’t, it’s unexpected. This distinction drives regulatory reporting obligations—unexpected, especially if serious, often triggers expedited reporting as a SUSAR, while expected events follow the standard safety reporting flow. It’s not about how many subjects are affected, whether the event is life‑threatening, or about when the trial ends. The key point is whether the ADR is described in the labeling or IB.

Expectedness in adverse drug reaction reporting means determining whether the reaction is already described in the drug’s reference safety information, specifically the labeling or the Investigator’s Brochure. If an ADR is listed there, it’s considered expected; if it isn’t, it’s unexpected. This distinction drives regulatory reporting obligations—unexpected, especially if serious, often triggers expedited reporting as a SUSAR, while expected events follow the standard safety reporting flow. It’s not about how many subjects are affected, whether the event is life‑threatening, or about when the trial ends. The key point is whether the ADR is described in the labeling or IB.

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