Audit Certificate is a formal document issued following an audit of clinical trial processes, data, or compliance. This certificate provides confirmation that the audit has been conducted and typically includes details about the audit scope, findings, and recommendations. It may be used for regulatory submission, quality assurance, and as evidence of compliance with research standards and regulations.
Definitions
ICH E6
A declaration of confirmation by the auditor that an audit has taken place [1].
See also
Links to this page
- Audit (← links)
- Glossary:Audit Certificate (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