Question: In accordance with ICH E 6 , audit is defined as: An educational review in order to develop a training program for the investigator A

In accordance with ICH E6, "audit" is defined as:
An educational review in order to develop a training program for the
investigator
A review of study data to assess safety
A systematic and independent examination of study-related activities and
documents
An activity that is conducted by regulatory authority(ies) to assess the
compliance to federal regulations
In accordance with ICH E6, "audit" is defined as: An educational

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