PharmaAudit Services
Site, TMF and Database Audit
Inspection Preparation
CRO Evaluation
SOP Development
GCP Testing & Training
GCP Training
GCP Knowledge Testing
Free GCP Games
Case Studies
Mock Inspection
TMF Audit
Administration
Home Page
Contact Us
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: 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

 
(c) PharmaAudit 2009
All rights reserved
PharmaAudit
Home Page
Contact Us
Related Companies
PharmaSchool Training
PharmaXM Online Testing
Services
Routine Audits
Inspection Preparation