Clinical Trial Audit

A Clinical Trial Audit is a Performance Audit that determines whether clinical trial-related activities were conducted according to a protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.

• Context:
  • It can produce a clinical trial audit certificate, report, and trail documents.
• Example(s):
  • …
• Counter-Example(s):
  • Academic Audit,
  • Clinical Audit,
  • Energy Audit,
  • Financial Audit,
  • Information Technology Audit,
  • Operational Audit,
  • Project Audit,
  • Quality Audit.
• See: Audit, Conformity Assessment, Clinical Trial Applicable Regulatory Requirement, Clinical Trial Protocol, Good Clinical Practice (GCP) Guideline, Clinical Trial Master File, Clinical Trial Application, 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
    • 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). (ICH E6)

2018

• (FDA, 2018) ⇒ FDA (2018). "E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) Guidance for Industry".
  • QUOTE: 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).

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