LMC Login | CPMC Login | My Games Account Login
Change Region: Asia | Europe | USA | UK | RoW
Register for Updates & Free Games Account
Complete the form below to register with us for updates. We will update you when new challenges and games are available to play.
First Name:
Surname:
Country:
Email:
Re-enter email:
If you would like a free PharmaSchool Games Account so you can record your weekly GCP Challenge Scores please check the box below and add a password:
Free Games Account:
Password:
Re-enter Password:
 
 
 
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: Protocol Design

Question Number 1:

Which of the following would be classed as surrogate endpoints?

1) Time to death

2) Reduction in LDL cholesterol

3) Increase in specific antibody level in testing a new vaccine

4) Relief of pain at 2 hours post dose

A
1 only
B
1 and 2 only
C
2 and 3 only
D
3 and 4 only

Question Number 2:

If you considered that the new product that you were testing was probably as effective as the chosen comparator but may be a little better which would be the most suitable form of trial?

A
non-comparative
B
superiority
C
equivalence
D
non-inferiority

Question Number 3:

You are contemplating a trial design for your new product against one of three competitor products; product A, product B or product C. The primary endpoint of the trial would be complete pain relief at 2 hours. It is expected that 65% of patients taking the new product would achieve pain relief at 2 hours. It is also expected that the pain relief rates for products A, B and C at 2 hours would be 60%, 62% and 58%. If you were looking to show a statistically significant difference between your product and the comparator product which of the comparators would require the trial to have the least number of patients?

A
A
B
B
C
C
D
Cannot tell

Question Number 4:

If you were looking for a guideline to provide some information about the choice of control group for your trial where would you look?

A
ICH E6
B
ICH E4
C
ICH E10
D
ICH E11

Question Number 5:

If you had a block size of 6. Two treatment groups A and B. The randomisation was a ratio of 2 to 1 with 2 in A and 1 in B. What would be the next two letters in the randomisation sequence following this:

AAAABBBAAB..?

A
AA
B
AB
C
BA
D
BB

Sort the Challenges
GCP & Guidelines
Trial Design
Adverse Events
Monitoring
Statistics
Abbreviations
General
Show All
International Sites: USA Europe Asia Rest of World
PharmaSchool Ltd. Registered in England & Wales No: 05439862
t: +44 (0) 845 224 0891 f: +44 (0) 845 224 0873 e: info@pharmaschool.co.uk