SOCRA CCRP Practice Exam

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When does subject discontinuation require reporting to the FDA?

For all discontinuations
When discontinuation is due to an adverse event or serious adverse event
Only in case of death
Never stated in regulation

The correct answer is: When discontinuation is due to an adverse event or serious adverse event

Subject discontinuation requires reporting to the FDA only when it is due to an adverse event or serious adverse event. While all discontinuations should be reported to the FDA, the question specifically asks about when it is required. Option A implies that all discontinuations require reporting, which is incorrect. Option C only covers a specific case and does not include adverse events or serious adverse events. And option D makes a false statement that is not supported by regulations. Therefore, option B is the best answer as it includes all relevant information and is the only one that specifically addresses when reporting is required.