Ace the SOCRA CCRP Exam 2024 – Become a Clinical Superstar!

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.