FDA Form 3454 & 3455

Question 1

What is FDA Form 3455?

Answer 1

Disclosure of Financial Interests and Arrangements of Clinical Investigators.

Question 2

Why is financial disclosure important in clinical research?

Answer 2

Financial disclosure is important to identify and manage any potential financial conflicts of interest that could affect the integrity and objectivity of clinical trial data.

Question 3

Who is required to submit FDA Form 3455?

Answer 3

Clinical investigators who are involved in conducting FDA-regulated clinical trials

Question 4

When should FDA Form 3454 and/or 3455 be submitted?

Answer 4

At the time of submitting the investigational new drug application (IND) or investigational device exemption (IDE) application.

Question 5

What types of financial interests are disclosed on FDA Form 3455?

Answer 5

The investigator’s equity interests, proprietary interests, and compensation arrangements.

Question 6

What is the purpose of disclosing equity interests on FDA Form 3455?

Answer 6

Disclosing equity interests helps identify whether the investigator has a financial stake in the sponsor company, which could potentially influence the conduct of the clinical trial.

Question 7

Explain the term “proprietary interest” in the context of FDA Form 3455.

Answer 7

Proprietary interests refer to any financial interest held by the investigator in the tested product or the sponsor company, excluding equity interests.

Question 8

Why is it important to disclose compensation arrangements on FDA Form 3455?

Answer 8

Disclosing compensation arrangements helps assess whether the investigator has financial relationships that could affect the interpretation of trial results.

Question 9

What are examples of compensation arrangements disclosed on FDA Form 3455?

Answer 9

Compensation arrangements include salary, consulting fees, honoraria, stock options, or any other payments related to the clinical trial.

Question 10

How does FDA Form 3455 contribute to subject safety in clinical trials?

Answer 10

By disclosing financial interests, the form helps ensure that investigators do not have financial relationships that might compromise the safety and well-being of research subjects.

Question 11

Who reviews the information provided on FDA Form 3455?

Answer 11

Both the sponsor, IRB, and the FDA

Question 12

What is the consequence of a significant financial interest on FDA Form 3455?

Answer 12

A significant financial interest may lead to the implementation of measures to manage or eliminate the conflict of interest, ensuring the integrity of the clinical trial.

Question 13

How does FDA Form 3455 contribute to transparency in clinical research?

Answer 13

Promotes transparency by disclosing financial interests, allowing stakeholders to evaluate the objectivity and reliability of clinical trial data.

Question 14

What actions can be taken if a financial conflict of interest is identified on FDA Form 3455?

Answer 14

Actions may include modifying the investigator’s role, monitoring the trial more closely, or implementing other measures to manage or eliminate the conflict.

Question 15

Can investigators with financial interests participate in clinical trials?

Answer 15

Investigators with financial interests can participate in clinical trials, but their interests must be disclosed, and appropriate measures must be taken to manage any conflicts.

Question 16

Can financial interests disclosed on FDA Form 3455 disqualify an investigator from participating in a clinical trial?

Answer 16

Disclosed financial interests do not automatically disqualify an investigator, but appropriate measures must be taken to manage any identified conflicts of interest.

Question 17

What is the role of the Institutional Review Board (IRB) in relation to FDA Form 3455?

Answer 17

The IRB reviews the information on FDA Form 3454 to ensure that the financial interests of investigators do not compromise the rights and safety of research subjects.

Question 18

How often is FDA Form 3455 updated during the course of a clinical trial?

Answer 18

Investigators are required to update FDA Form 3454 within 30 days of any changes to their financial interests during the course of the clinical trial.

Question 19

What are the potential consequences of non-compliance with FDA Form 3455 requirements?

Answer 19

Non-compliance with FDA Form 3454 requirements may result in regulatory actions, including the suspension or termination of clinical trials.

Question 20

What is FDA Form 3454?

Answer 20

Certification of NO Financial Interests or Arrangements of Clinical Investigators.

Question 21

What information does FDA Form 3455 collect?

Answer 21

FDA Form 3455 collects information about financial interests, arrangements, and affiliations that the clinical investigator or their spouse and dependent children have that could be affected by the outcome of the clinical trial.