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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: PharmaSchool Favourites

Question Number 1:
A patient in a clinical trial breaks his leg in a skiing accident - is it an SAE?
A
 No - it's not even an AE
B
 Yes - no question
C
 Yes if he stayed in hospital overnight or had serious complications
D
 Only if he withdrew from the study

Question Number 2:
Which of the following does not appear in the list of information to be given to subjects?
A
 Aspects of the trial which are experimental
B
 Payment to the investigator
C
 Compensation available in the event of a trial-related injury
D
 That records identifying the subject will be kept confidential

Question Number 3:
Which of the following is not a Class I Medical Device
A
 Non Invasive Medical Device not used for storing blood or body liquids.
B
 Non Invasive Device used as a mechanical barrier, compression or for absorption of exudates on damaged skin.
C
 Non Invasive Device used to manage the micro environment of a wound.
D
 Invasive device with respect to a body orifice not connected to an active medical device and intended for transient use.

Question Number 4:
What does ANOVA stand for?
A
 Analysis of Visual Analogues
B
 Analysis of Virtial Analogues
C
 Analysis of Variance
D
 Analysis of Variability

Question Number 5:
With 3 treatment groups A, B, and C and a block size of 6 which of the following could complete the sequence: ABCCABBCABACBBA???
A
 BAC
B
 ACC
C
 BCA
D
 AAC

Question Number 6:
Which of the following is the odd one out?
A
 FDA
B
 TGA
C
 WHO
D
 IMB

Question Number 7:
If you had to reduce the sample size when designing a study which of the following might you consider?
A
 Increase the power
B
 Decrease the power
C
 Increase the expected variability in the data
D
 Increase both power and variability

Question Number 8:
Lab tests: what does ELISA stand for?
A
 Elevated Lipolysis Indictator Standard Assessment
B
 ElectroLysis ImmunoStability Assay
C
 Enzyme Linked ImmunoSorbent Assay
D
 Electrophoretic Lysis Indicator Standard Assay

Question Number 9:

According to ICH GCP when an investigator's/institution's participation is terminated because of serious and/or persistent noncompliance identified through monitoring or audit what should the sponsor do?

1) Ensure that all subjects involved in the trial at the specific site are followed up

2) Promptly notify the regulatory authority(ies)

3) Provide training to the investigational site staff

4) Ensure that all payments received by the investigator/institution are returned to the sponsor

Which of the following is correct?
A
 1 only
B
 2 only
C
 3 and 4 only
D
 1 and 2 only

Question Number 10:

According to ICH GCP if the answer to the question is "Monitoring" what could the question be?

a) Which process is used to verify that the rights and well-being of human subjects are protected

b) Which process is used to verify that the reported trial data are accurate, complete, and verifiable from source documents

c) Which independent process is used to determine whether trial related activities were conducted to the protocol, the SOPs, GCP and the applicable regulatory requirements
A
 a or b only
B
 b or c only
C
 a, b or c
D
 a only

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