Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 4.8-001
From GxPlex
| 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 5 — Unit 5.4.1 |
| Scope | G |
| Document part | Appendix B
4.8 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Stopping rules, Protocol, Study design |
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.
