Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8.12
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
2.8.12 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Assent, Minor / Paediatric, Consent process, Informed consent |
Content
2.8.12 Where a minor is to be included as a participant, age-appropriate assent information should be provided and discussed with the minor as part of the consent process, and assent from the minor to enrol in the trial should be obtained as appropriate. A process for consent should be considered if, during the course of the trial, the minor reaches the age of legal consent, in accordance with applicable regulatory requirements.
