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Weekly GCP Challenge

Answer the questions below and then click the button. The next page will mark your answers and show you how well you have done compared with the previous people who have taken the tests.


Challenge: Clinical Research Forms

Question Number 1:
The form detailing Findings and Observations from an FDA Inspection is known as which form number?
A
 438
B
 483
C
 1571
D
 1572

Question Number 2:
The FDA Form entitled Investigational New Drug Application is which number?
A
 1571
B
 1572
C
 2001/20
D
 93/41

Question Number 3:

Which FDA form includes the following statements:

  • I agree to conduct the study(ies) in accordance with the relevant, current protocol(s) and will only make changes in a protocol after notifying the sponsor, except when necessary to protect the safety, rights, or welfare of subjects.
  • I agree to personally conduct or supervise the described investigation(s).
A
 1571
B
 1572
C
 483
D
 Investigator Agreement

Question Number 4:
If you received an FDA Form 482 what would this notify you of?
A
 Being suspended from taking part in clinical trials
B
 A Critical Inspection Finding requiring immediate response
C
 A forthcoming FDA Inspection
D
 A debarment notice

Question Number 5:
If you had completed and submitted an FDA Form 356h what would be doing?
A
 Applying for Orphan Drug Status
B
 Applying for IND Status
C
 Applying to market a new drug
D
 Applying to have an end of Phase II meeting with FDA

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