Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.11.2

Document Information

Document information
Reference	ICH ICH E6 Guideline R3 (2025)
Validity area	ICH
Scope(s)	HM
Document name	ICH E6 Guideline
Version / Revision	R3 (2025)
Status	Current
Document type	International guideline
Language(s)	EN
Description	GUIDELINE FOR GOOD CLINICAL PRACTICE
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details

Scope	G
Document part	III. Annex 1 3.11.2
Language	EN
Original entry by	Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment	Audit conduct, scope and documentation requirements

Text

3.11 Quality Assurance and Quality Control [...] 3.11.2 Audit When performed, audits should be conducted in a manner that is proportionate to the risks associated with the conduct of the trial (see section 3.10.1.1). The purpose of a sponsor’s audit, which is independent of and separate from routine monitoring or quality control functions, is to evaluate whether the processes put in place to manage and conduct the trial are appropriate to ensure compliance with the protocol, GCP and the applicable regulatory requirements.

3.11.2.1 Selection and Qualification of Auditors (a) The sponsor should appoint individuals who are independent of the clinical trial/processes being audited. (b) The sponsor should ensure that the auditors are qualified by training and experience to conduct audits properly.

3.11.2.2 Auditing Procedures (a) The sponsor should ensure that the auditing of clinical trials/processes is conducted in accordance with the sponsor’s documented procedures on what to audit, how to audit (i.e., on-site and/or remote), the frequency of audits and the form and content of audit reports.

(b) The sponsor’s audit plan, program and procedures for a trial audit should be guided, for example, by the importance of the trial to submissions to regulatory authorities, the number of participants in the trial, the type and complexity of the trial, the level of risks to the trial participants and any identified problem(s).

(c) The observations and findings of the auditor(s) should be documented.

(d) To preserve the independence and value of the audit function, the regulatory authority(ies) should not routinely request the audit reports. Regulatory authority(ies) may seek access to an audit report on a case-by-case basis (i.e., when evidence or suspicion of serious GCP noncompliance exists or in the course of legal proceedings).

(e) When required by applicable regulatory requirements, the sponsor should provide an audit certificate.