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Self-assessment

1. Multi-choice

Question

Which of the following statements best describes what an ‘adverse event (AE)’ is?

Answers

An adverse event is any unfavourable and unintended medical occurrence in a subject of research, which is caused by a research procedure.

An adverse event is any unfavourable and unintended medical occurrence in a subject of research, regardless of its cause.

An adverse event is any unfavourable and unintended medical occurrence in a subject of a clinical drug trial.

An adverse event is any unfavourable and unintended drug reaction in a subject of a clinical drug trial.

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