Which scenario requires the submission of an SAE report?

The requirement to submit a Serious Adverse Event (SAE) report is based on the severity and implications of the adverse event experienced by a participant. In this case, when a subject shows serious allergic reactions that require immediate medical intervention, it meets the criteria for an SAE. Serious allergic reactions can pose significant health risks and could lead to critical situations that might affect the participant's wellbeing. The necessity for immediate medical intervention indicates that the reaction is not only serious but also potentially life-threatening, thus triggering the obligation to report the occurrence as it might impact the trial safety evaluation and necessitate prompt actions or changes in protocol.

Other scenarios, such as the participant developing a headache that is managed with over-the-counter medication, experiencing brief dizziness that does not require treatment, or undergoing a routine physical examination, do not pose serious health risks nor demand urgent medical intervention. These instances are typically classified as non-serious and do not warrant an SAE report as they do not meet the threshold established for serious adverse events.