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 is the legal status of ICH guidelines in the U.S.?

Mandatory regulation
Voluntary guideline
State law
FDA endorsed standard

The correct answer is: Voluntary guideline

The legal status of ICH guidelines in the U.S. is considered voluntary guidelines, meaning they are not mandatory by law but are strongly recommended to be followed by those in the pharmaceutical industry. Option A is incorrect because ICH guidelines are not enforced by any regulatory body and do not have the force of law. Option C is incorrect because ICH guidelines are not state laws, but rather international standards. Option D is incorrect because while the FDA (Food and Drug Administration) may refer to or adopt ICH guidelines, they are not considered an endorsement from the FDA and do not hold the same legal weight as mandatory regulations or laws.