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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: GCP 2008

Question Number 1:
What of the following international guidelines was updated in October 2008?
A
 ICH GCP
B
 Declaration of Helsinki
C
 Nuremberg Code
D
 CIOMS/WHO guidelines

Question Number 2:
For which of the following did FDA incude a definition in 21 CFR part 312 in 2008?
A
 Independent Ethics Committee
B
 Serious Adverse Event
C
 Suspected Unexpected Serious Adverse Reaction
D
 Serious Breach

Question Number 3:
What was the subject of the 5 new guidelines issued in Euralex Vol 10 in June 2008?
A
 Serious Breaches
B
 Adverse Drug Reactions
C
 GCP Inspections
D
 Annual safety reports

Question Number 4:
Which regulatory authority requires Serious Breaches of GCP or the protocol to be reported within 7 days?
A
 FDA
B
 EMEA
C
 MHRA
D
 WMA

Question Number 5:
What was the subject of the update to 21CFR part 312 which became effective in October 2008
A
 IRBs
B
 SUSARs
C
 Serious Breaches
D
 Acceptance of data from foreign clinical studies not conducted under an IND

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