21 CFR 54

Question 1

What are the reasons for potential source of bias due to financial interest in the outcome of the study?

Answer 1

1. The way payment is arranged (royalties)
2. The investigator has a proprietary interest in the product
3. The investigator has an equity interest in the sponsor of the covered study

Question 2

What does the applicant need to submit to FDA for a marketing application for approval of a drug, device or biologic product when the submission relies partly or fully on clinical data?

Answer 2

1. List of all clinical investigators who conducted covered clinical studies
2. Identify clinical investigators who are full-time or part-time employees of the sponsor
3. Completely and accurately disclose or certify information concerning the financial interests of a clinical investigator who is not full-time or part-time employee of the sponsor
4. Certification (Form 3454) or Disclosure statement (Form 3455)

Question 3

What is the Form 3454?

Answer 3

Attests to the absence of financial interests and arrangements described under “Disclosure of statement”.

Question 4

What is FDA Form 3455?

Answer 4

Discloses the following:
1. Financial arrangements between the sponsor and the clinical investigator
2. Any significant payments of other sorts from the sponsor
3. Any proprietary interest in the tested product
4. Any significant equity interest in the sponsor
5. Any steps taken to minimize the potential for bias resulting from any of the disclosed arrangements, interests, or payments

Question 5

What are the record retention requirements for the applicant (submitting to FDA)?

Answer 5

1. Complete records showing any financial interest or arrangement
2. Complete records showing significant payments of other sorts
3. Complete records showing any financial interests held by clinical investigators (proprietary interest in the tested product, significant equity in the sponsor)