SOCRA CCRP Practice Exam

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Master the SOCRA CCRP Exam with our comprehensive practice quiz. Tailored feedback, detailed explanations, and real-world scenarios to boost your confidence and success.

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IVD studies don't need informed consent if they meet which criteria?

If IDE submission is necessary and the trial is overseen by the FDA
Leftover specimens are used and the trial is not overseen by any regulatory body
If IDE submission unnecessary, leftover specimens used, investigators different from caregivers, and overseen by IRB among others
All trials need informed consent without exception

The correct answer is: If IDE submission unnecessary, leftover specimens used, investigators different from caregivers, and overseen by IRB among others

In this question, the correct answer is C because it states that if all four criteria are met (IDE submission is unnecessary, leftover specimens are used, investigators are different from caregivers, and the trial is overseen by IRB), then informed consent is not needed for IVD studies. This means that if any one of those criteria is not met, informed consent would be required. Option A is incorrect because it only mentions the need for IDE submission and FDA oversight, but it does not mention the other criteria that need to be met. Option B is incorrect because while it mentions the use of leftover specimens, it does not mention any oversight by a regulatory body. Option D is incorrect because it states that all trials need informed consent, which is not true based on the criteria listed in the question.