Audits and Inspections of Clinical Trials of Drugs and Biologics Quiz

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When the FDA conducts an inspection, the inspectors will:

Review regulatory records.

The overall goal of monitoring, audits, and inspection activities is to:

Ensure the protection of human research subjects and data integrity.

According to ICH E6 GCP, an "Audit" is defined as:

A systematic and independent examination of trial-related activities and documents.

OHRP is an oversight body primarily concerned with:

Protection of human research subjects.

According to ICH E6 GCP, an inspection is defined as:

An official review of documents, facilities, records, and any other resources related to a clinical trial.

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