SOCRA CCRP Practice Exam

What is the purpose of FDA Form 3454?

1. Certification of financial disclosure for investigators with no financial disclosures

2. Disclosure statement for financial disclosure of clinical investigators who have disclosable interests

3. Application to test a new medical device

4. Voluntary adverse event reporting by healthcare professionals

The correct answer is: Certification of financial disclosure for investigators with no financial disclosures

The purpose of FDA Form 3454 is to certify that investigators have no financial disclosures. This form is required for clinical trials and research studies conducted by the FDA, as it verifies that the investigator has no financial conflicts of interest that could potentially influence the outcome of the study. The other options (B, C, and D) are incorrect as they refer to different purposes of forms used by the FDA for different purposes. Option B refers to a disclosure statement for clinical investigators who do have disclosable financial interests, Option C refers to an application for testing new medical devices, and Option D refers to a voluntary adverse event reporting form for healthcare professionals. These options may be used for different purposes, but they do not serve the same purpose as FDA Form 3454.