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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: ICH GCP - Which document?

Question Number 1:
According to ICH GCP which document should be retained to document compliance with applicable labelling regulations?
A
 Certificate of Analysis
B
 Sample of labels
C
 QP Release
D
 Drug Accountability forms

Question Number 2:
According to ICH GCP which document shows that the site is suitable for the trial?
A
 Protocol
B
 Investigator's CV
C
 1572
D
 Pre-trial monitoring report

Question Number 3:
According to ICH GCP which document demonstrates that the investigator is informed in a timely manner of relevant information as it becomes available?
A
 Protocol amendments
B
 SAE reports
C
 Investigtor's Brochure updates
D
 Audit reports

Question Number 4:
According to ICH GCP which documents document the existence of the subject and substantiate integrity of trial data collected?
A
 Informed Consent
B
 Source Documents
C
 CRFs
D
 Subject Identification log

Question Number 5:
According to ICH GCP which document permits identification of all subjects enrolled in the trial in case follow-up is required?
A
 Source Documents
B
 Subject Identification Code List
C
 Informed consent forms
D
 No document - this should not be permitted.

 
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