FDA Forms

Question 1

FDA Form 482

Answer 1

Letter of of intent to inspect

-Notice of inspection

Question 2

Form 3500

Answer 2

Voluntary reporting of adverse events found in the course of clinical care
-for healthcare professionals and consumers

Question 3

Form 3500A

Answer 3

Mandatory reporting for sponsors, manufacturers, importers, user facilities for adverse events found

Question 4

Form 3500B

Answer 4

Voluntary reporting for consumers

-consumer version of form 3500

Question 5

FDA Form 3454

Answer 5

A certification that no financial interests exists

Question 6

FDA form 3455

Answer 6

Complete disclosure statement

Question 7

FDA Form 483

Answer 7

If objectionable conditions are observed during an FDA audit. The inspector will provide this document which includes the name of the sponsor/CRO, date of inspection and lists observations made during inspection

Question 8

FDA form 1572

Answer 8

Signed declaration of the investigator that he/she will comply with FDA regulations on clinical trial conduct.
-required to be completed and signed prior to start of study