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Weekly GCP Challenge

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.


Challenge: ICH GCP - CRO and Sponsor

Question Number 1:

What is missing from this statement in ICH GCP?

"A sponsor may transfer XXXXXXX of the sponsor's trial-related duties and functions to a CRO"
A
 Some
B
 All
C
 None
D
 Any or all

Question Number 2:

According to ICH GCP what always resides with the sponsor?

 
A
 Ultimate responsibility for the trial
B
 Ultimate responsibility for subject safety
C
 Ultimate responsibility for the quality and integrity of the trial data
D
 Ultimate responsibility for meeting the applicable local regulatory requirements

Question Number 3:

According to ICH GCP what "should the CRO implement" when sponsor's trial related duties are transferred to the CRO?
A
 Quality Assurance and Monitoring
B
 Quality Control and Auditing
C
 Quality Assurance and Quality Control
D
 SOPs

Question Number 4:

According to ICH GCP any trial related duty and function that is transferred to and assumed by a CRO should be what?
A
 Agreed and documented
B
 Documented in a contract or scope of work
C
 Done so only after the procedures of the CRO have been verified by audit
D
 Specified in writing

Question Number 5:

According to ICH GCP any trial related duties and functions not specifically transferred and assumed by a CRO are what?
A
 Retained by the sponsor
B
 Jointly assumed by the CRO and Sponsor
C
 To be documented
D
 To be specified in writing

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