Back to AI Flashcard MakerAuditing /Audits and Inspections of Clinical Trials
According to ICH E6, an inspection is defined as:
An inspection is defined as the act by a regulatory authority of conducting an official review of documents, facilities, records, and any other resources related to a clinical trial. A systematic and independent examination of trial-related activities and documents is 'an audit' and the act of overseeing the progress of a clinical trial is 'monitoring.'
Tap or swipe ↕ to flip
Swipe ←→Navigate
1/5
Key Terms
Term
Definition
According to ICH E6, an inspection is defined as:
An inspection is defined as the act by a regulatory authority of conducting an official review of documents, facilities, records, and any other resour...
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, 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
Study Tips
- Press F to enter focus mode for distraction-free studying
- Review cards regularly to improve retention
- Try to recall the answer before flipping the card
- Share this deck with friends to study together
| Term | Definition |
|---|---|
According to ICH E6, an inspection is defined as: | An inspection is defined as the act by a regulatory authority of conducting an official review of documents, facilities, records, and any other resources related to a clinical trial. A systematic and independent examination of trial-related activities and documents is 'an audit' and the act of overseeing the progress of a clinical trial is 'monitoring.' |
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, 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 |