CITI Training Practice Exam

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In the United States, following the ICH E6 GCP for FDA-regulated drug studies is:

  1. Voluntary

  2. Mandatory for studies conducted outside the United States

  3. Mandatory for investigational device studies

  4. Mandatory for all drug studies

The correct answer is: Voluntary

Following the ICH E6 GCP for FDA-regulated drug studies is voluntary in the United States. This means that while it is highly recommended to follow these guidelines for conducting clinical trials in the US, it is not a legal requirement. Options B, C, and D are incorrect because they imply that following ICH E6 GCP guidelines is mandatory in various circumstances, which is not the case in the US.

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