Ace the SOCRA CCRP Exam 2025 – Become a Clinical Superstar!

Question: 1 / 400

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

Only unexpected serious adverse reactions

All adverse events

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.

Get further explanation with Examzify DeepDiveBeta

Only events leading to discontinuation of the trial

Next Question

Report this question

Download Ace the SOCRA CCRP Exam 2025 – Become a Clinical Superstar! PDF Study Guide
Subscribe

Get the latest from Examzify

You can unsubscribe at any time. Read our privacy policy