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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: GCP - New EU requirements

Question Number 1:
What is a PUMA?
A
 Planned Utilisation of Medicines in Adults
B
 Protocol for Underage Medical Advancement
C
 Paediatric Use Marketing Authorisation
D
 Paediatric Utilisation Medicines Agency

Question Number 2:
Which of the following is covered by a European Regulation?
A
 Development of a Paediatric Investigation Plan for new products
B
 Contents of the Trial Master File
C
 Non-Investigational Medicinal Products
D
 Specific Modalities for Non-commercial studies

Question Number 3:
Which of the following is considered Non-IMP under EU guidance?
A
 Placebo control
B
 Active comparator
C
 Open label investigational product
D
 Rescue medication

Question Number 4:
In the new EU guidance on first-in-human clinical trials what is MABEL
A
 A method of randomisation
B
 An assessment of the mechanism of action of Monoclonal Antibodies
C
 A means of calculating dose level
D
 A specialised type of phase I clinical trials unit

Question Number 5:
According to EU guidance on the TMF where should the Certificate of Analysis for the first batch of IMP be filed?
A
 Both sponsor and investigator files
B
 Sponsor file only
C
 Investigator file only
D
 In the Manufacturing site file only

 
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