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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: Hardest GCP Related Questions

Question Number 1:
Which of the following ICH Guidelines is entitled ‘Statistical Principles for Clinical Trials’?
A
 E3
B
 E5
C
 E7
D
 E9

Question Number 2:
Which of the Code of Federal Regulations governs electronic signatures in clinical trials?
A
 21CFR21
B
 11CFR21
C
 21CFR11
D
 12CFR21

Question Number 3:
What does SSAR stand for?
A
 Suspected Serious Adverse Reaction
B
 Secondary Serious Adverse Reaction
C
 Serious Specific Adverse Reaction
D
 Serious Specified Adverse Reaction

Question Number 4:
Under FDA regulations how long does the Sponsor have to keep the clinical trial records?
A
 2 years after marketing authorization or discontinuation of drug
B
 3 years after end of clinical trial
C
 5 years after end of clinical trial
D
 15 years after end of clinical trial

Question Number 5:
Which word(s) are missing from the following in the ICH GCP definition of an SOP: "Detailed, written instructions to achieve XXX of the performance of a specific function"
A
 quality
B
 reliability
C
 uniformity
D
 consistency

Question Number 6:
According to ICH GCP which of the following is the odd one out in terms of where it/they should be filed?
A
 Audit Certificate
B
 Master Randomisation List
C
 Monitoring Visit Reports
D
 Subject Identification Code List

Question Number 7:
The _________ is responsible for the ongoing safety evaluation of the investigational product
A
 investigator
B
 IEC/IRB
C
 regulatory authority
D
 sponsor

Question Number 8:
What word(s) is missing from the statement in ICH GCP: Well-being - The physical and mental XXX of the subjects participating in a clinical trial.
A
 appropriateness
B
 condition
C
 integrity
D
 status

Question Number 9:
Which word is missing from ICH GCP: The investigator should have XXXXXXX time to properly conduct and complete the trial within the agreed trial period.
A
 specified
B
 set aside
C
 selected
D
 sufficient

Question Number 10:
What is a PUMA?
A
 Planned Utilisation of Medicines in Adults
B
 Protocol for Underage Medical Advancement
C
 Paediatric Use Marketing Authorisation
D
 Paediatric Utilisation Medicines Agency

Question Number 11:
What words complete the statement in ICH GCP: The sponsor should determine for investigational products acceptable storage temperatures, storage conditions, storage times, XXXXX, and devices for product infusion, if any.
A
 resupply procedure
B
 relabelling and randomisation methods
C
 reconstitution fluids and procedures
D
 return storage conditions

Question Number 12:
Which O is defined in ICH GCP as the judgement and/or advice provided by an Ethics Committee?
A
 Obligation
B
 Observation
C
 Opinion
D
 Order

Question Number 13:
What year is considered to be the birth date of ICH?
A
 1986
B
 1988
C
 1990
D
 1992

Question Number 14:
What year was the original ICH GCP finalised?
A
 1993
B
 1994
C
 1995
D
 1996

Question Number 15:
What does ICH GCP state about how an auditor should be qualified?
A
 by a either a bioscience degree, a nursing or medical qualification or similar
B
 by training in SOPs, regulatory guidelines and the protocol
C
 by training and experience to conduct audits properly
D
 by relevant experience as a Monitor

Question Number 16:
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 17:
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

Question Number 18:
According to Annexe 13 which of the following is most true about emergency codebreaks?
A
 They should be available before the first patient is randomised
B
 They should be available before drug is shipped to the site
C
 They should be available before manufacture commences
D
 They should be available before the QP reviews the batch for release

Question Number 19:
P - What P is missing from this statement: If the trial is blinded, the investigator should promptly document and explain to the sponsor any XXXX unblinding.
A
 Premature
B
 Previous
C
 Preventable
D
 Planned

Question Number 20:
What is the difference between an SAE and a SUSAR?
A
 There is no difference
B
 SUSARs are unexpected SAEs
C
 Expectedness and relation to study drug
D
 SUSARs are more severe

 
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