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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 - General Considerations for Clinical Trials

Question Number 1:
According to Guideline ICH E8 Before any clinical trial is carried out, results of non-clinical investigations or previous human studies should be sufficient to indicate what?
A
 potential benefit of the drug over existing treatments
B
 the appropriate dose for use in clinical trials
C
 that the drug is acceptably safe for the proposed investigation in humans
D
 that there is a potential market for the drug

Question Number 2:
According to Guideline ICH E8 who is responsible for the protection of trial subjects?
A
 The sponsor
B
 The investigator
C
 The IRB/IEC
D
 All of the above

Question Number 3:
According to Guideline ICH E8 which type of clinical trial has defining/describing pharmacokinetics and pharmacodynamics as one of its objectives?
A
 Human Pharmacology
B
 Therapeutic Exploratory
C
 Therapeutic Confirmatory
D
 Therapeutic Use

Question Number 4:
What does Guideline ICH E8 recommend with regard to inclusion of pregnant women in clinical trials?
A
 They should never be included
B
 There should always be clinical trials in pregnant women
C
 They should only be included if the drug is intended for use in pregnancy
D
 There is no recommendation

Question Number 5:
Guideline ICH E8 describes methods used to minimise or assess bias. Which methods are described?
A
 Randomisation and blinding
B
 Randomisation and compliance
C
 Blinding and compliance
D
 Randomisation, blinding and compliance

 
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