Questions and Answers
What do FDA inspectors do during an inspection?
Review regulatory records.
What is the overall goal of monitoring, audits, and inspection activities?
Ensure the protection of human research subjects and data integrity.
How is an 'Audit' defined according to ICH E6 GCP?
A systematic and independent examination of trial-related activities and documents.
What is OHRP primarily concerned with?
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How is an inspection defined according to ICH E6 GCP?
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Study Notes
FDA Inspections
- FDA inspectors review regulatory records during inspections to assess compliance and safety measures.
Goals of Monitoring and Audits
- The primary objective of monitoring, audits, and inspections is to protect human research subjects and maintain the integrity of data collected during clinical trials.
Definition of an Audit
- An "Audit," as per ICH E6 GCP, represents a systematic and independent evaluation of trial-related activities and documentation to ensure compliance with established guidelines.
OHRP's Role
- The Office for Human Research Protections (OHRP) focuses on safeguarding the rights and welfare of human research subjects involved in clinical trials.
Definition of an Inspection
- An "Inspection," according to ICH E6 GCP, involves an official review of all relevant documents, facilities, records, and resources connected to a clinical trial to confirm their validity and adherence to regulations.
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Description
Test your knowledge on the audits and inspections involved in clinical trials of drugs and biologics. This quiz covers key terms and definitions related to FDA inspections, monitoring activities, and ICH GCP guidelines. Perfect for students and professionals in clinical research.
