CITI Training Practice Exam

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Which of the following reports must be filed using an FDA Form 1572?

  1. Annual Reports

  2. Addition of a new investigator

  3. Protocol amendments

  4. Informed Consent Document

The correct answer is: Addition of a new investigator

The correct answer to this question is B. Addition of a new investigator must be filed using an FDA Form 1572. This is because an FDA Form 1572 is used to document the investigator's agreement to comply with FDA regulations and to conduct the clinical trial in accordance with the study protocol. Annual reports, protocol amendments, and informed consent documents do not require the use of an FDA Form 1572.

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