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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 Site Requirements

Question Number 1:
According to ICH GCP the investigator "should be qualified by....."?
A
 training and experience
B
 education, training and experience
C
 education and experience
D
 education and training

Question Number 2:
According to ICH GCP the investigator should be "thoroughly familiar with......."?
A
 Applicable regulatory requirements
B
 GCP
C
 Clinical Trial Conduct
D
 Appropriate use of the investigational product(s)

Question Number 3:
According to ICH GCP the investigator should be "able to demonstrate........"?
A
 Knowledge of GCP
B
 That all persons involved in the study have been appropriately trained
C
 A potential for recruiting the required number of subjects within the agreed recruitment period
D
 Understanding of the protocol

Question Number 4:
According to ICH GCP the sponsor should obtain the investigator's agreement to.....?
A
 To conduct the trial in accordance with GCP and applicable regulatory requirements
B
 To comply with procedures for data recording/reporting
C
 To permit monitoring
D
 All of the above

Question Number 5:
According to ICH GCP what should the sponsor do before entering into an agreement with the investigator/institution?
A
 Provide a protocol and an up to date Investigators Brochure
B
 Check the investigator's qualifications
C
 Perform a visit to assess the site
D
 All of the above

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