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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: IMP labelling

Question Number 1:
Where would you find the labelling requirements for IMP in Europe?
A
 GMP Directive
B
 GCP Directive
C
 Clinical Trials Directive
D
 Annexe 13

Question Number 2:
Where would you find the labelling requirements for IMP in the US?
A
 21 CFR part 312
B
 21 CFR part 11
C
 21 CFR part 50
D
 21 CFR part 54

Question Number 3:
According to Annexe 13 which of the following can be omitted from an IMP label if the subject has been given a card containing the information and instructed to carry it at all times?
A
 The batch number
B
 The contact for emergency unblinding
C
 The trial reference code
D
 The storage conditions

Question Number 4:
According to Annexe 13 which of the following can be omitted from the label on the immediate container provided it remains with its outer packaging?
A
 Expiry date
B
 Batch number
C
 Name of sponsor, CRO or investigator
D
 Trial reference code

Question Number 5:
Which of the following is NOT included in the list of information required on IMP labels in Annexe 13?
A
 Batch number
B
 Period of use
C
 Subject initials
D
 Storage conditions

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