Challenge: ICH GCP Audits
Question Number 1
Which of the following does ICH GCP define as the purpose of a sponsors audit?
A
To evaluate trial conduct and compliance with the protocol and other requirements
B
To evaluate trial conduct and compliance with the protocol, SOPs, GCP and the applicable regulatory requirements
C
To determine whether the appropriate regulations and guidelines are being followed correctly
D
To ensure the integrity of the data and the safety of the trial subjects

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