Audits And Inspections Of Clinical Trials Of Drugs And Biologics Quiz

12 September 2022

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question

When the FDA conducts an inspection, the inspectors will:

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Review regulatory records.

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

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Ensure the protection of human research subjects and data integrity.

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

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

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OHRP is an oversight body primarily concerned with:

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Protection of human research subjects.

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

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