Exam 2

Question 1

_____ ensures that trial related obligations and acceptability of resultan clinical data is in support of a new drug approval.

Answer 1

Inspection

Question 2

In a _____ the inspector is an employee of the company who work for an active clinical quality assurance

Answer 2

Audit

Question 3

FDA form 482 is

Answer 3

Notice of Inspection

Question 4

After the inspection, the written response of form 483 should be sent to FDA in ________days

Answer 4

15 days

Question 5

During the inspection, you can make a copy of the inspector’s badge

True or false

Answer 5

False

Question 6

The mock FDA auditor review the policy for retaining records and products control at the facilities on a day _______?

Answer 6

Day 2

Question 7

What is a way to explain and correct unexpected departures from the protocol?

Answer 7

Note to File