SOCRA CCRP Practice Exam

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What is FDA Form 1572?

  1. Cover page for IND application

  2. Quality assurance audit form

  3. Financial disclosure form

  4. Statement of investigator

The correct answer is: Statement of investigator

FDA Form 1572 is a form used by the Food and Drug Administration (FDA) to document a Statement of Investigator (SOI). An SOI is a legally binding document that must be completed by the principal investigator (PI) for any clinical investigation in the United States subject to FDA regulations. It details the information about the PI such as their name and qualifications, the protocol of the study, and the commitments made by the PI to comply with FDA regulations. Therefore, options A, B, and C are incorrect as they do not accurately describe the purpose of FDA Form 1572.

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