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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 - Investigator responsibilities

Question Number 1:
What does ICH GCP say the investigator should do in the event of premature unblinding?
A
 Document the date, time and reason
B
 Promptly document and explain to the sponsor
C
 Document and report to the sponsor and the Ethics Committee
D
 It doesn't specify

Question Number 2:
Complete the sentence from ICH GCP: The investigator should ensure that investigational products are used....
A
 only in accordance with the approved protocol.
B
 only for subejcts enrolled in the clinical trial.
C
 only for the approved indication.
D
 only in the institution conducting the clinical trial.

Question Number 3:
Who does ICH GCP say should inform the subject about the trial?
A
 The investigator
B
 A member of the investigational site staff.
C
 The investigator or a person designated by the investigator.
D
 The sponsor.

Question Number 4:
How frequently does ICH GCP require the investigator to submit reports to the Ethics Committee?
A
 It doesn't - it's the sponsor's responsibility
B
 Annually
C
 At the end of the trial
D
 The frequency is not specified.

Question Number 5:
What are the ICH GCP requirements for consent for non-therapeutic clinical trials?
A
 The subject should sign and date the form personally.
B
 There must be a witness to the consent process.
C
 There is no difference from the requirements for a therapeutic clincial trial.
D
 It must be the Principal Investigator who obtains consent.

 
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