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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: GCP 2007

Question Number 1:
Of what is this the ICH GCP definition: "an investigational or marketed product or placebo being used as a reference in a clinical trial"?
A
 Investigational Product
B
 Concomitant medication
C
 Comparator
D
 Background Medication

Question Number 2:
In the new EU legislation what does ATMP stand for?
A
 Applied Technology Medicinal Product
B
 Advanced Therapy Medicinal Product
C
 Advanced Technology Medical Protocol
D
 Applied Technology Medical Protocol

Question Number 3:
According to the new EU guideline on IMPs and Non-IMPs which of the following would NOT be considered a Non-IMP?
A
 Placebo control
B
 Concomitant medication
C
 Rescue medication
D
 Background Medication

Question Number 4:
Under GCP who has primary responsibility for the welfare of clinical trial subjects?
A
 Sponsor
B
 Ethics Committee
C
 Regulatory Authority
D
 Investigator

Question Number 5:
According to ICH GCP chapter 8 where should ORIGINAL completed CRF pages be filed?
A
 In the sponsor files
B
 In the site file
C
 Either the sponsor file or the site file is OK as long as it is stated in the protocol
D
 It doesn't specify

Question Number 6:
According to ICH GCP who is responsible for the content of the Patient Information Sheet?
A
 The sponsor
B
 The investigator
C
 The Ethics Committee
D
 The Monitor

Question Number 7:
Which of the following is most true about the requirements for reporting serious breaches of GCP and the protocol to the MHRA (UK Regulatory Authority)?
A
 Only breaches at UK sites need to be reported
B
 All breaches need to be reported regardless of where in the world they occur
C
 Breaches don't need to be reported if the sponsor is based outside the UK
D
 Any breach which affects study integrity or the safety of UK subjects must be reported regardless of where in the world they occur

Question Number 8:
What is a normal range?
A
 The windows within which subject visits must take place
B
 The range within which subject's laboratory values must fall for subjects to be eligible for the study
C
 The range of laboratory tests which a laboratory is capable of performing
D
 The range of test results for that laboratory which is normally seen in healthy people

Question Number 9:
Which of the following is NOT an ICH GCP requirement for the Investigator's Brochure?
A
 The investigator should sign a copy of the Investigator's Brochure
B
 A medically qualified person should participate in the editing
C
 A copy should be provided to the Ethics Committee
D
 The sponsor is responsible for providing the current version to investigators

Question Number 10:
In which of the following circumstances would a witness be required to sign the consent form?
A
 When a legal representative gives consent on behalf of the subject
B
 When the subject is unable to read or write
C
 When the subject receives no therapeutic benefit from the trial
D
 All of the above

 
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