Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.9.3

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
Module	Module 4 — Unit 4.1.3
Scope	G
Document part	III. Annex 1 3.9.3
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Protocol deviation, Sponsor, Protocol, Data integrity

Content

3.9.3 The sponsor should determine necessary trial-specific criteria for classifying protocol deviations as important. Important protocol deviations are a subset of protocol deviations that may significantly impact the completeness, accuracy and/or reliability of the trial data or that may significantly affect a participant’s rights, safety or well-being.