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

  1. 20 calendar days

  2. 15 working days

  3. 10 calendar days

  4. 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.