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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 Definitions

Question Number 1:
Of what is this part of the ICH GCP definition: "The act by a regulatory authority of conducting an official review of documents..."?
A
 Inspection
B
 Audit
C
 Clinical Trial Authorisation
D
 Source Data Verification

Question Number 2:
Of what is this part of the ICH GCP definition: "A person who is independent of the trial, who cannot be unfairly influenced by people involved with the trial........."?
A
 Peer reviewer
B
 IDMB
C
 Impartial witness
D
 Auditor

Question Number 3:
Of what is this the ICH GCP definition: " prevention of disclosure, to other than authorised individuals, of a sponsor's proprietary information or of a subject's identity."?
A
 Data protection
B
 Source data verification
C
 Confidentiality
D
 Inspection

Question Number 4:
Of what is this part of the ICH GCP definition: "all noxious and unintended responses to a medicinal product related to any dose"?
A
 Adverse Event
B
 Adverse Drug Reaction
C
 Investigators Brochure
D
 Protocol

Question Number 5:
Of what is this part of the ICH GCP definition: "A unique identifier assigned by the investigator to each trial subject to protect the subject's identity"
A
 Randomisation code
B
 Code break
C
 Data protection clause
D
 Subject Identification Code

 
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