FORMS

Question 1

FDA Form 482

Answer 1

Notice of FDA inspection - presented by FDA at site for investigation

Question 2

FDA Form 483

Answer 2

FDA inspectional observations - observations made by FDA during inspection, given to site

Question 3

FDA Form 1571

Answer 3

IND cover sheet titled “Investigational New Drug Application”, part of title 21, code of federal regulations (CFR) part 312

Question 4

FDA Form 1572

Answer 4

Statement of Investigator

Question 5

FDA Form 3454

Answer 5

Certification - Financial Interests and Arrangements of Clinical Investigators (21 CFR part 54)

-if none of the investigators have any FDA required disclosures

Question 6

FDA Form 3455

Answer 6

Disclosure - Financial interests and arrangements of clinical investigators (title 21 CRF part 54)

• if any clinical investigator has a financial disclosure that is significant
• updated for 1 year following completion

Question 7

Medwatch 3500

Answer 7

for voluntary reporting of adverse events and product problems

• IND safety report
• condensed version of 3500A, voluntary reporting of AE’s by healthcare professionals, consumers, patients

Question 8

Medwatch 3500A

Answer 8

for use by user facilities, distributors, and manufacturers for mandatory reporting
-mandatory reporting of AE’s by manufacturer, user facilities, importers

A = mAndatory
= mAnufacturer

Question 9

CIOMS I

Answer 9

Council for International Organizations of Medical Sciences

• sponsor may submit foreign suspected adverse reactions on this instead of a FDA form 3500A
• standard for expedited AE reporting