Clinical Trial Audit Report

A Clinical Trial Audit Report is an Audit Report that a written evaluation of the results of a clinical trial audit.

• Example(s):
  • …
• Counter-Example(s):
  • Clinical Trial Audit Certificate,
  • Clinical Trial Master File,
  • Clinical Trial Audit Trail.
• See: Clinical Trial Applicable Regulatory Requirement, Clinical Trial Protocol, Good Clinical Practice (GCP) Guideline, Clinical Trial Information System, Clinical Trial Management System.

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References

2021

• (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Glossary_of_clinical_research Retrieved:2021-11-14.
  • QUOTE: Audit report
    • A written evaluation by the sponsor's auditor of the results of the audit. (ICH E6)

2018

• (FDA, 2018) ⇒ FDA (2018). "E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) Guidance for Industry".
  • QUOTE: 1.8 Audit Report
    • A written evaluation by the sponsor’s auditor of the results of the audit.

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