Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 2.5
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 4 â Unit 4.1.1 |
| Scope | G |
| Document part | Appendix B
2.5 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Compliance, Protocol, Good clinical practice, Amendment |
Content
Appendix B. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S) [...] B.2.5 A statement that the trial will be conducted in compliance with the protocol, Good Clinical Practice (GCP) and the applicable regulatory requirement(s). [...]
