Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 8
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| 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 â Unit 5.3.2 |
| Scope | G |
| Document part | Appendix B
8 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Protocol, Endpoint, Data monitoring committee, Amendment |
Content
Appendix B. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S) [...] B.8 Assessment of Efficacy B.8.1 Specification of the efficacy parameters, where applicable. B.8.2 Methods and timing for assessing, recording and analysing efficacy parameters. Where any trial-related committees (e.g., independent data monitoring committee (IDMC)/adjudication committees) are utilised for the purpose of assessing efficacy data, the committeesâ procedures, timing and activities should be described in the protocol or a separate document.
