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Which criterion is used to determine if a study of an approved drug is exempt from the requirement of an IND?

  1. The study intends to invoke an exception from informed consent

  2. The study involves a route of administration that significantly increases the risks

  3. The study is not intended to be reported to FDA to support a new indication or support a labeling change

  4. The study intends to involve more than 100 patients

The correct answer is: The study is not intended to be reported to FDA to support a new indication or support a labeling change

The criterion used to determine if a study of an approved drug is exempt from the requirement of an IND is whether the study is not intended to be reported to the FDA to support a new indication or a labeling change. This is because if the study is not intended to provide new information about the drug, it does not need to go through the IND process. Option A is incorrect because an exception from informed consent would not determine if a study is exempt from the requirement of an IND. This applies to studies where the participants are unable to provide informed consent due to their medical condition. Option B is incorrect because the route of administration would not determine if a study is exempt from the requirement of an IND. This criterion may be used to assess the risks and benefits of a study, but it does not determine whether the study is required to go through the IND process. Option D is incorrect because involving more than

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