Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 1.2.7
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 3 â Unit 3.1.4 |
| Scope | G |
| Document part | III. Annex 1
1.2.7 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Assent, Minor / Paediatric, Ethics committee, Requirements |
| Comment | IRB/IEC review of assent information for minors |
Content
1.2.7 If minors are to be included in a trial, the IRB/IEC should review the assent information considering the age, maturity and psychological state of the minor population intended to be enrolled, as well as applicable regulatory requirements.
