Audit
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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(R2)
- 1.6 Audit:
- 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].
- 1.7 Audit Certificate:
- A declaration of confirmation by the auditor that an audit has taken place [1].
- 1.8 Audit Report:
- A written evaluation by the sponsor's auditor of the results of the audit [1].
Audit report
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.
Audit certificate
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.
See also
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References
- ↑ 1.0 1.1 1.2 ICH, 2016, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf Accessed Sep 2023