Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 4.8-001

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	Appendix B 4.8
Language	EN
Original entry by	Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment	Repeated entry: 5.4.1 ++ 5.4.2 Protocol content: stopping rules, discontinuation and dose adjustment criteria

Content

B.4 Trial Design […] B.4.8 A description of the “stopping rules” or “discontinuation criteria” and “dose adjustment” or “dose interruption” for individual participants, for parts of the trial or for the entire trial.