Challenge: Audits and Inspections
Question Number 1

What is the following definition of from ICH GCP?

 

"The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor's and/or contract research organization’s (CRO’s) facilities, or at other establishments deemed appropriate by the regulatory authority(ies). "

 

A
Audit
B
Regulatory Approval
C
CTA
D
Inspection

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