CITI Training Practice Exam

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Is the ICH GCP a regulation or a guideline?

Regulation
Guideline
Depends on the country
Both A and B

The correct answer is: Depends on the country

The ICH GCP is a set of guidelines developed by the International Council for Harmonisation (ICH) that provides a framework for designing, conducting, and reporting clinical trials. While many countries have adopted the ICH GCP guidelines, they are not legally binding and do not have the force of law. Therefore, it would be more accurate to view them as recommendations rather than regulations.