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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.

Test: FDA Regulations

Question Number 1:
What does IND stand for?
A
 Institutional Novel Department
B
 Investigational New Drug
C
 Investigational Novel Derivative
D
 Investigational Notification of a Drug

Question Number 2:
Which of the following is most true about a CROs responsibilities under 21 CFR part 312?
A
 The CRO is not responsible for the study
B
 The sponsor is not responsible for the study
C
 References to Sponsor in the regulations apply to the CRO for specific tasks delegated in writing to the CRO
D
 If all tasks are transferred every individual task must still be detailed in writing

Question Number 3:
According to 21 CFR part 312 what is the timeline for reporting adverse events which are related to the drug, fatal or life threatening and unexpected?
A
 7 days
B
 15 days
C
 30 days
D
 24 hours

Question Number 4:
What does IRB stand for?
A
 Investigational Review Board
B
 Investigational Review Body
C
 Institutional Review Body
D
 Institutional Review Board

Question Number 5:
When should progress reports on an IND clincial trial be submitted to FDA?
A
 Within 30 days of the anniversary of the date the IND went into effect
B
 On the anniversary of the date the IND went into effect
C
 Within 60 days of the anniversary of the date the IND went into effect
D
 The date the sponsor has agreed with the FDA

 
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