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A subject enrolled in a study at SLU has been admitted to the emergency room for a non-study related illness. Does this event need to be reported to the SLU IRB as a Serious Adverse Event (SAE)?

April 26, 2017emergency Enrolled illness non-study room slu study Subject

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A subject enrolled in a study at SLU has been admitted to the emergency room for a non-study related illness. Does this event need to be reported to the SLU IRB as a Serious Adverse Event (SAE)?

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No. The IRB does not require submission of events that are not reasonably related to the protocol (e.g., motor vehicle accident).