SOCRA CCRP Practice Exam

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What is a FDA Form 1571?

  1. Statement of investigator

  2. Financial disclosure form

  3. Cover page for IND application

  4. Quality assurance audit form

The correct answer is: Cover page for IND application

The FDA Form 1571 is the cover page for an Investigational New Drug (IND) application. This form is used to provide basic information about the sponsor, the drug, and the proposed clinical trials. Option A, the Statement of Investigator, is used to document the investigator's compliance with FDA regulations and commitments to the study. Option B, the Financial Disclosure form, is used to disclose any potential financial conflicts of interest for the sponsor, investigators, and institutional review board members. Option D, the Quality Assurance Audit form, is used to document the results of an audit performed to ensure compliance with FDA regulations.

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