SOCRA CCRP Practice Exam

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Within how many working days should a sponsor notify the FDA of the completion/termination of a SR device trial?

10 working days
20 working days
30 working days
40 working days

The correct answer is: 30 working days

Within 30 working days is the correct timeframe for a sponsor to notify the FDA of the completion or termination of a SR device trial. This allows the FDA to promptly review and assess the results of the trial. The other options (10, 20, and 40 working days) are incorrect as they either give the FDA too short a time to review the results (10 and 20 working days) or too long a time which can delay the approval process (40 working days). It is important for sponsors to adhere to the designated timeframe to ensure timely and efficient communication with the FDA.