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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: ICH GCP definitions

Question Number 1:
What word is missing from this ICHGCP definition of an Adverse Event: Any medical occurance in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
A
 direct
B
 investigational
C
 untoward
D
 No word is missing

Question Number 2:
What word is missing from this ICHGCP definition of a Case Report Form?: A printed or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.
A
 optical
B
 investigational
C
 accurately
D
 No word is missing

Question Number 3:
What word is missing from this ICHGCP definition of the Audit Trail?: Documentation that allows reconstruction of the course of events.
A
 complete
B
 accurate
C
 future
D
 No word is missing

Question Number 4:
What word is missing from this ICHGCP definition of the protocol?: A document that describes the objective(s), design, statistical consderations, and organization of a trial.
A
 written
B
 methodology
C
 clinical
D
 No word is missing

Question Number 5:
What word is missing from this ICHGCP definition of SOPs?: Written instructions to achieve uniformity of the performance of a specific function.
A
 Detailed
B
 Complete
C
 Comprehensive
D
 No word is missing

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