CITI Training Practice Exam

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Question: 1 / 400

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

Annual Reports

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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Protocol amendments

Informed Consent Document

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