SOCRA CCRP Practice Exam

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What types of events must sponsors report to the FDA within 15 calendar days?

  1. Only unexpected serious adverse reactions

  2. All adverse events

  3. Serious and unexpected suspected adverse reactions among others

  4. Only events leading to discontinuation of the trial

The correct answer is: Serious and unexpected suspected adverse reactions among others

Sponsors are required to report any serious and unexpected suspected adverse reactions to the FDA within 15 calendar days. This includes a variety of adverse events such as deaths, life-threatening events, hospitalizations, and other serious events that may not have been previously noted in the protocol or study. Option A is incorrect because sponsors are also required to report unexpected serious adverse reactions, not just expected ones. Option B is incorrect because not all adverse events need to be reported, only those that are serious and unexpected. Option D is incorrect because events leading to discontinuation of the trial may not necessarily be serious or unexpected and would not require immediate reporting.

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