SOCRA CCRP Practice Exam

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What is a specific reporting timeline for sponsors concerning serious and unexpected suspected adverse reactions?

20 calendar days
15 working days
10 calendar days
15 calendar days

The correct answer is: 15 calendar days

A specific reporting timeline for sponsors concerning serious and unexpected suspected adverse reactions is 15 calendar days. This means that any sponsor who becomes aware of a serious and unexpected reaction to their product must report it to the appropriate authority within 15 calendar days. It is important to note that options A, B, and C are incorrect because they either mention a different unit of time (working days instead of calendar days) or a different time frame (10 calendar days instead of 15). This emphasizes the importance of paying attention to specific requirements and guidelines when it comes to reporting adverse reactions.