Audit Report is a comprehensive and formal document generated after an audit of clinical trial activities, processes, or data. This report outlines the scope of the audit, details the audit methodology, presents findings, identifies areas of non-compliance, and may offer recommendations for corrective actions. It serves as an essential record of audit outcomes, facilitating quality assurance, regulatory compliance, and process improvement in clinical research.
Definitions
ICH E6
A written evaluation by the sponsor's auditor of the results of the audit [1].
See also
Links to this page
- Glossary:Audit Report (redirect page) (← links)
References
- ↑ ICH website, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf