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Weekly GCP Challenge

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Challenge: ICH GCP - Investigator Qualifications and Agreements

Question Number 1:

What does ICH GCP state about how an investigator should be qualified?

"The Investigator should be qualified by.................."

1) Education

2) Training

3) Experience

Which of the above are missing from the statement?
A
 1 and 2 only
B
 2 and 3 only
C
 1 and 3 only
D
 1, 2 and 3

Question Number 2:

According to ICH GCP the Investigator should meet all the qualifications specified by whom?
A
 the sponsor
B
 the applicable regulatory requirements
C
 the IEC/IRB
D
 ICH GCP

Question Number 3:

What is missing from this statement from ICH GCP?

"The investigator should be XXXXXX with the appropriate use of the investigational product"
A
 fully trained
B
 experienced
C
 thoroughly familiar
D
 familiar

Question Number 4:

According to ICH GCP Section 4.1 the investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated what?
A
 Responsibility
B
 Specific Activities
C
 Significant Trial-Related Duties
D
 Trial Activities

Question Number 5:

According to ICH GCP Section 4.1 the investigator/institution should permit what by the sponsor?
A
 Monitoring
B
 Auditing
C
 Monitoring and Auditing
D
 Monitoring, Auditing and Direct Access to all subject documentation

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