Audits and Inspections of Clinical Trials of Drugs and Biologics Quizzes 2023
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.