An audit is a systematic and independent examination of trial-related activities and records performed by the sponsor, service provider, including a contract research organisation (CRO), or institution. It determines whether trial-related activities were conducted and data were recorded, analysed, and accurately reported according to the protocol, applicable standard operating procedures (SOPs), good clinical practice (GCP), and applicable regulatory requirements.

A sponsor’s audit is independent of and separate from routine monitoring and quality control functions. When performed, audits are conducted in a manner proportionate to the risks associated with the conduct of the trial.

Regulatory definitions

ICH E6(R3)

Audit

A systematic and independent examination of trial-related activities and records performed by the sponsor, service provider (including contract research organisation, CRO) or institution to determine whether the evaluated trial-related activities were conducted and the data were recorded, analysed and accurately reported according to the protocol, applicable standard operating procedures (SOPs), good clinical practice (GCP) and the applicable regulatory requirement(s) 1.

Audit Certificate

A declaration of confirmation by the auditor that an audit has taken place.

Audit Report

A record describing the conduct and outcome of the audit.

Audit certificate

An audit certificate is a declaration by the auditor confirming that an audit has taken place. Under ICH E6(R3), the sponsor should provide an audit certificate when required by applicable regulatory requirements.

Audit Report

An audit report is a record describing the conduct and outcome of an audit. ICH E6(R3) requires the observations and findings of auditors to be documented and specifies that the sponsor’s documented procedures should define the form and content of audit reports.

References

  1. International Council for Harmonisation. 2026. ICH E6(R3): Consolidated Guideline for Good Clinical Practice.
    Available at: https://database.ich.org/sites/default/files/ICH%20E6%28R3%29_Step4_FinalConsolidatedGuideline_2026_0616_.pdf ↩︎