CITI Training Practice Exam

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What standards will the FDA apply?

  1. The ICH E6 GCP standards

  2. The Code of Federal Regulations

  3. Local IRB requirements

  4. State law where the sponsor's headquarters are located

The correct answer is: The Code of Federal Regulations

The FDA will apply the Code of Federal Regulations (CFR) standards in regulating drug development and clinical trials in the United States. The ICH E6 GCP standards (A) are guidelines developed by the International Council for Harmonisation and are not directly enforced by the FDA. While local IRB requirements (C) may also apply to clinical trials, they are not the primary standards used by the FDA in regulating drug development. State law (D) may also have an impact on clinical trials, but it is not the main set of standards used by the FDA. Therefore, the correct answer is B the Code of Federal Regulations.

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