FDA Forms

Question 1

FDA Form 482

Answer 1

Notice of Inspection

Question 2

FDA Form 483

Answer 2

Inspectional Observations

Question 3

FDA Form 1572

Answer 3

Statement of Investigator

Question 4

FDA Form 3454

Answer 4

Certification – Financial Interests and Arrangements of Clinical Investigators

Question 5

FDA Form 3455

Answer 5

Disclosure – Financial Interests and Arrangements of Clinical Investigators.

Question 6

FDA Form 3500

Answer 6

For Voluntary Reporting of Adverse Events and Product Problems.

Question 7

FDA Form 3500A

Answer 7

For use by User-Facilities, Distributors, and Manufacturers for Mandatory Reporting.

Question 8

For an IND, what FDA form is filled out by the investigator as an agreement between the sponsor and investigator to perform the trial according to the appropriate rules and regulations?

Answer 8

FDA Form 1572.

Question 9

Which FDA forms are filled out if the Investigator has financial interests and arrangements that they need to disclose?

Answer 9

FDA Form 3455.

Question 10

Which FDA forms are filled out if the Investigator has NO financial interests and arrangements that they need to disclose?

Answer 10

FDA Form 3454.