Clinical Trial Audit

From GM-RKB
(Redirected from clinical trial audit)
Jump to navigation Jump to search

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.



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).