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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: Investigational Medicinal Products

Question Number 1:
According to the EU guideline on IMPs and other medicinal products, which of the following would be considered NON-IMP?
A
 Open label investigational products
B
 Open label comparator
C
 Rescue medication
D
 Placebo control

Question Number 2:
Which of the following is NOT a labelling requirement for IMP in a blinded clinical trial?
A
 Product name
B
 Contact name for product information
C
 Dosage form
D
 Subject identification number

Question Number 3:
According to the EU GMP directive how long should batch samples of IMP be retained?
A
 Until the end of the clinical trial
B
 At least one year after the end of the clinical trial
C
 At least 2 years after the end of the clinical trial
D
 5 years after the end of the clinical trial

Question Number 4:
According to Annexe 13 which of the following is most true about emergency codebreaks?
A
 They should be available before the first patient is randomised
B
 They should be available before drug is shipped to the site
C
 They should be available before manufacture commences
D
 They should be available before the QP reviews the batch for release

Question Number 5:
Which of the following is the QP NOT required to review before signing the batch release?
A
 Finished packs
B
 Stability reports
C
 Regulatory documents at the investigational site
D
 Production conditions

 
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