CITI Training Practice Exam

Question: 1 / 400

Which document is the ICH E6 guideline for good clinical practice directly aligned with?

The Constitution of WHO

The Declaration of Helsinki

The ICH E6 guideline for good clinical practice is directly aligned with the Declaration of Helsinki. This is because the Declaration of Helsinki is an internationally accepted ethical standard for conducting medical research on human subjects, which is the focus of the ICH E6 guideline. The other options, such as the Constitution of WHO and the GLP guidelines, may have some overlap with the principles of good clinical practice, but they are not directly aligned with the ICH E6 guideline. Additionally, the ICH Q9 Quality Risk Management is a separate guideline that focuses on risk management in the pharmaceutical industry, rather than ethics in clinical trials. Therefore, the Declaration of Helsinki is the best option that aligns with the ICH E6 guideline.

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The ICH Q9 Quality Risk Management

The Good Laboratory Practice (GLP) guidelines

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