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. |
Audits and Inspections of Clinical Trials of Drugs and Biologics Quiz
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