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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: Clinical Research - Things I Should Know

Question Number 1:
What type of blinding is described here: Patients all receive two types of medication at the same time, one is active and one is placebo?
A
 Double dummy
B
 Cross over
C
 Double blind
D
 Parallel

Question Number 2:
Who does ICH GCP say should inform the subject about the trial?
A
 The investigator
B
 A member of the investigational site staff.
C
 The investigator or a person designated by the investigator.
D
 The sponsor.

Question Number 3:
If separate predetermined randomisation schemes are created for sub-groups based on prognostic factors what type of randomisation would this be?
A
 Minimisation
B
 IVRS
C
 Stratification
D
 Simple randomisation

Question Number 4:
In a placebo controlled trial for pain relief it is often appropriate to allow subjects to take an alternative medication after a specified amount of time if they have not achieved adequate pain relief. What is this additional medication called?
A
 Active control
B
 Cross over medication
C
 Standard Therapy
D
 Rescue Medication

Question Number 5:

What is ICH E6 better known as?
A
 Declaration of Helsinki
B
 Good Manufacturing Practice
C
 Good Clinical Practice
D
 Safety Reporting in Post Registration Studies

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