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Investigators must report SAEs to the sponsor within how many days of discovering the event?

  1. Immediately

  2. 5 days

  3. 10 days

  4. 15 days

The correct answer is: Immediately

SAEs (Serious Adverse Events) must be reported to the sponsor immediately upon discovery because timely reporting is crucial in ensuring the safety and well-being of participants in a clinical trial. Waiting even 5, 10, or 15 days may result in potential harm to participants or delay in taking necessary actions. Therefore, the other options are incorrect because they suggest a longer time frame, which could be detrimental to the safety of the participants. Reporting SAEs immediately also allows the sponsor to act quickly and appropriately, potentially preventing any further incidents.