Ace the CITI Training Test 2026 – Rock Your Research Cred!

Question: 1 / 400

What do the ICH GCP guidelines set standards for?

Guarantee of marketing approval in any ICH region

Certification of clinical research sites and investigators

Replacement of FDA regulations for international studies

The design, conduct, monitoring, and reporting of clinical research

The ICH GCP (International Conference on Harmonization Good Clinical Practice) guidelines set standards for the design, conduct, monitoring, and reporting of clinical research. This includes guidelines for protecting the rights, safety, and well-being of study participants, ensuring the quality and integrity of data, and defining the roles and responsibilities of all involved parties. Option A is incorrect because the ICH GCP guidelines do not guarantee marketing approval, but rather ensure ethical and scientifically sound research. Option B is incorrect as certification of clinical research sites and investigators is not specifically addressed in the ICH GCP guidelines. Option C is incorrect because the FDA regulations are not replaced, but rather supplemented, by the ICH GCP guidelines to ensure consistency and quality in international clinical trials.

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