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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: General ICH GCP Questions

Question Number 1:
What word(s) are missing from the ICH GCP statement: The sponsor is responsible for the ongoing XXXXXXX of the investigational product?
A
 effiicacy evaluation
B
 safety evaluation
C
 efficacy assessments
D
 safety assessments

Question Number 2:
What does ICH GCP refer to as a trial in which there is no anticipated direct clinical benefit to the subject?
A
 Phase I trial
B
 Pilot Trial
C
 Non-therapeutic Trial
D
 Non-comparative trial

Question Number 3:
What does ICH state should be weighted against the anticipated benefit for the individual trial subject and society before a trial is initiated?
A
 foreseeable risks and inconveniences
B
 immediate and long terms costs and risks
C
 long term safety issues
D
 safety issues and inconveniences

Question Number 4:
According to ICH GCP non-compliance with the protocol, SOPs, GCP and/or regulatory requirements by an investigator/institution or member(s) of the sponsor staff should lead to what?
A
 an audit being performed by the sponsor
B
 a suspension of all trial related work at the site
C
 prompt action by the sponsor to secure compliance
D
 an additional monitoring visit by the sponsor

Question Number 5:
ICH GCP states that any trial-related duties and functions not specifically transferred to and assumed by a CRO are what?
A
 shared between the CRO and sponsor
B
 automatically the responsibility of the sponsor
C
 automatically the responsibility of the CRO
D
 retained by the sponsor

 
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