Challenge: ICH GCP Monitoring
Question Number 1
According to ICH GCP Section 5.18 Monitoring, which of the following is not stated under the section entitled Selection and Qualification of Monitors
A
Monitors should be appointed by the sponsor.
B
Monitors should be thoroughly familiar with the safety reporting procedures of the trial and should ensure the training is documented and updated on a regular basis.
C
Monitors should be thoroughly familiar with the investigational product(s), the protocol, written informed consent form and any other written information to be provided to subjects, the sponsorís SOPs, GCP, and theapplicable regulatory requirement(s).
D
Monitors should be appropriately trained, and should have the scientific and/or clinical knowledge needed to monitor the trial adequately. Amonitorís qualifications should be documented.

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