CITI Training Practice Exam

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Each practice test/flash card set has 50 randomly selected questions from a bank of over 500. You'll get a new set of questions each time!

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What does ICH require regarding the awareness of subjects if there is no intended clinical benefit in the ICF?

Subjects must be informed about the lack of intended clinical benefit.
Subjects must be informed only about the potential risks.
Subjects should not be informed about the study's benefits or lack thereof.
Only the subjects' legal representatives need to be informed.

The correct answer is: Subjects must be informed about the lack of intended clinical benefit.

ICH requires subjects to be informed about the lack of intended clinical benefit in the informed consent form (ICF). This is important because it promotes transparency and allows subjects to make an informed decision about participating in the study. Option B is incorrect because subjects should not only be informed about potential risks, but also any lack of intended benefit. Option C is incorrect because subjects have the right to know about the study's benefits and potential risks. Option D is incorrect because both the subjects and their legal representatives should be informed about the lack of intended clinical benefit.