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 action did the FDA take in 2003 concerning Part 11 regulations?

Issued new guidelines for food safety
Implemented stricter controls on drug labeling
Withdrew guidance documents related to Part 11 for re-examination
Launched a campaign to improve clinical trial reporting

The correct answer is: Withdrew guidance documents related to Part 11 for re-examination

In 2003, the FDA took action to withdraw guidance documents related to Part 11 regulations for re-examination. This means that they temporarily suspended the use of previous guidelines in order to review and revise them for better effectiveness and accuracy. This does not mean that the FDA completely abandoned their regulation of this area, but rather sought to improve and update it. Options A, B, and D are all incorrect because they do not reflect the specific action that the FDA took in regards to Part 11 regulations. In addition, they are also unrelated to the FDA's regulatory responsibilities, as food safety, drug labeling, and clinical trial reporting fall under different areas of their authority. Therefore, option C is the most appropriate and specific answer.