Challenge: GCP Challenge 52
Question Number 1
According to ICH GCP Section 2: The Principles of GCP which of the following is not one of the 13 stated priniciples?
A
A clinical trial should be conducted using the smallest number of trial subjects considered adequate to provide a robust and accurate answer to the trial objectives.
B
The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).
C
The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.
D
A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favourable opinion.

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