Audit is systematic and independent examination or review of clinical trial data, records, procedures, and documentation. It is conducted to verify compliance with regulatory requirements, protocol adherence, and data accuracy. Audits are critical in ensuring the integrity and quality of clinical research and may be carried out by regulatory authorities, sponsors, or independent auditing entities. An Audit certificate is issued by auditor upon completion of audit related activities.
Definitions
ICH E6
A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor's standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s) [1].
See also
Links to this page
- Regulatory inspection (← links)
- Quality assurance (← links)
- Quality control (← links)
- Corrective and Preventive Action (← links)
- Standard operating procedures (← links)
- Glossary:Audit (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