SOCRA CCRP Practice Exam

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Which forms might a sponsor use to submit a complete financial disclosure statement for an investigator to the FDA?

  1. FDA Form 3455

  2. FDA Form 3465

  3. FDA Form 3454

  4. FDA Form 3454/option 3

The correct answer is: FDA Form 3455

A sponsor would submit a complete financial disclosure statement for an investigator to the FDA using FDA Form 3455. This form is specifically designed for sponsors to disclose financial interests that could potentially create a conflict of interest for the investigator conducting the study. The other options listed are either incorrect or redundant. FDA Form 3465 is used for reporting financial interests of clinical investigators to the sponsor, not the FDA. FDA Form 3454 is used for disclosure by clinical investigators to the sponsor, and Option 3 under FDA Form 3454 is not a valid option. Therefore, the only correct and relevant option is FDA Form 3455.

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