SOCRA CCRP Practice Exam

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What must a sponsor do if the FDA requests more information about an IND safety report for drug studies?

  1. Respond within 7 days

  2. Respond no more than 15 calendar days from receipt of request

  3. Ignore the request as it's optional

  4. Request an extension

The correct answer is: Respond no more than 15 calendar days from receipt of request

The FDA requires sponsors to respond within 15 calendar days from receipt of a request for more information about an IND safety report for drug studies. Option A is incorrect because it states a specific time frame of 7 days, which is not in line with the FDA's regulations. Option C is incorrect because the request for more information is not optional - it is a requirement from the FDA. Option D is also incorrect because the sponsor cannot request an extension; they must respond within the specified time frame.

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