Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.12

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 3.12
Language	EN
Original entry by	Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment	Sponsor noncompliance handling procedures

Text

3.12 Noncompliance

3.12.1 Noncompliance with the protocol, SOPs, GCP and/or applicable regulatory requirement(s) by an investigator/institution or by member(s) of the sponsor’s staff should lead to appropriate and proportionate action by the sponsor to secure compliance.

3.12.2 If noncompliance that significantly affects or has the potential to significantly affect the rights, safety or well-being of trial participant(s) or the reliability of trial results is discovered, the sponsor should perform a root cause analysis, implement appropriate corrective and preventive actions and confirm their adequacy unless otherwise justified. Where the sponsor identifies issues that are likely to significantly impact the rights, safety or well-being of the trial participant(s) or the reliability of trial results (i.e., serious noncompliance), the sponsor should notify the regulatory authority and/or IRB/IEC, in accordance with applicable regulatory requirements, and/or investigator, as appropriate.

3.12.3 If significant noncompliance is identified on the part of an investigator/institution or service provider that persists despite efforts at remediation, the sponsor should consider terminating the investigator’s/institution’s or service provider’s participation in the trial. In these circumstances, the sponsor should promptly notify the regulatory authority(ies) and IRB/IEC of the serious noncompliance, as appropriate, and take actions to minimise the impact on the trial participants and the reliability of the results.