CITI Training Practice Exam

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Form FDA 1572 is a legal document between the Investigator and which entity?

Subjects
Sponsor
FDA
IRB

The correct answer is: FDA

Form FDA 1572 is a legal document between the investigator and the FDA. This form is used to detail the responsibilities of the investigator and to provide information about the study to the FDA. Options A, B, and D are incorrect because they do not accurately represent the purpose of the Form FDA 1572. The subjects are not a legal entity and are not responsible for the study. The sponsor may be involved in the study, but they are not the focus of this form. The IRB is responsible for reviewing and approving the study, but they are not directly involved in the legal agreement between the investigator and the FDA. Therefore, the FDA is the correct answer as it is the agency responsible for regulating and overseeing clinical trials.