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Challenge:
ICH GCP: Can you do better?
Question Number
1
According to ICH GCP non-compliance with the protocol, SOPs, GCP and/or regulatory requirements by an investigator/institution or member(s) of the sponsor staff should lead to what?
A
an audit being performed by the sponsor
B
a suspension of all trial related work at the site
C
prompt action by the sponsor to secure compliance
D
an additional monitoring visit by the sponsor
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