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Weekly GCP Challenge

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Challenge: 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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