GCP Challenge 52
According to ICH GCP Section 2: The Principles of GCP which of the following is not one of the 13 stated priniciples?
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.
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).
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.
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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