SOCRA CCRP Practice Exam 2025 – 400 Free Practice Questions to Pass the Exam

Question: 1 / 400

Within how many calendar days must sponsors report Serious Adverse Events (SAEs) to the FDA?

5 days

10 days

15 days

The correct answer is 15 days. This is because under the FDA's regulations, sponsors are required to report SAEs within 15 calendar days to the FDA and any other applicable entities, such as the Institutional Review Board. Options A, B, and D are not correct because they do not fall within the required timeframe of 15 days. Reporting SAEs promptly is essential for the safety and well-being of clinical trial participants, and failure to do so can result in serious consequences for both the sponsor and the trial participants. It is important for sponsors to adhere to this reporting requirement to ensure the protection of the participants and the integrity of the trial data.

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30 days

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