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GCP Tests

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.

Test: ICH GCP Section 6

Question Number 1:
Section 6 of ICH GCP lists the contents that should generally be included in a trial protocol. Which of the following is not included in the statement that the protocol should include Methods and timing for XXXXXXX of efficacy parameters?
A
 assessing
B
 validating
C
 recording
D
 analysing

Question Number 2:
Section 6 of ICH GCP states the protocol should generally include stopping rules for individual subjects, parts of trials and entire trial. What other term does it specify in addition to Stopping Rule?
A
 Interim Analyses
B
 Endpoints
C
 Termination Criteria
D
 Discontinuation Criteria

Question Number 3:
According to section 6 of ICH GCP which of the following is NOT one of the procedures generally included in protocols regarding Subject Withdrawal Criteria?
A
 How to define withdrawals due to lack of efficacy, safety or subject no longer wanting to continue
B
 When and how to withdraw subjects from the trial
C
 The type and timing of the data to be collected for withdrawn subjects
D
 Whether and how subjects are to be replaced

Question Number 4:
What is the word missing from the following statement regarding the content of the statistics section of a protocol in ICH GCP Section 6. Procedure for accounting for missing, unused and XXXXXX data.
A
 non-validated
B
 subjective
C
 spurious
D
 outlying

Question Number 5:
ICH GCP Section 6 states that which of the following would be generally included in the Background Information of a trial protocol
A
 The potential market size for the product in development
B
 Summary of the known and potential risks and benefits, if any, to human subjects
C
 A detailed discussion of the ethical considerations of the trial design
D
 A discussion of alternative designs that would adequately answer the same trial objectives

 
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