Question: Question 2 According to ICH E 6 , an audit is defined as: A systematic and independent examination of trial - related activities and documents.
Question
According to ICH E an "audit" is defined as:
A systematic and independent examination of trialrelated activities and documents.
The act of overseeing the progress of a clinical trial.
An institutional selfassessment.
An official review of documents, facilities, records, and any other resources related to a clinical trial.
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