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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: Seasonal Quiz

Question Number 1:
S - What does S stand for in SAE?
A
 Suspected
B
 Severe
C
 Serious
D
 Sustained

Question Number 2:
E - According to the 2008 update to 21CFR 312 what does E stand for in IEC ?
A
 Ethics
B
 Environmental
C
 Essential
D
 Elective

Question Number 3:
A - What does A stand for in the lab value ALT
A
 Aspartate
B
 Alanine
C
 Acid
D
 Alternate

Question Number 4:
S - Which S must be reported to MHRA within 7 days of the sponsor becoming aware?
A
 Fatal or lifethreatening SUSARs
B
 SAEs
C
 Serious Breaches
D
 both A and C

Question Number 5:
O - What O should be included in a protocol according to section 6.3 of ICH GCP?
A
 Organisation
B
 Obligations
C
 Operational aspects
D
 Objectives

Question Number 6:
N - what N is used to assess the significance of clinical laboratory results?
A
 Null Hypothesis
B
 Normal Distribution
C
 Normal Range
D
 Nominal Data

Question Number 7:
A - What does A stand for in the lab value AST
A
 Aspartate
B
 Alanine
C
 Acid
D
 Alternate

Question Number 8:
L - What is a Latin Square?
A
 A method of blinding where both products are changed to look like the opposite treatment
B
 A type of trial design used when several products are to be tested
C
 A statistical result which shows that the opposite result has been acheived from that which was expected
D
 A type of dance

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