Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.8.13
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
2.8.13 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Legal representative, Informed consent, Assent, Consent form, Trial participant |
| Comment | Consent requirements for participants requiring legal representative |
Content
2.8.13 When a clinical trial includes participants who may only be enrolled in the trial with the consent of the participantâs legally acceptable representative, the participants should be informed about the trial in a manner that facilitates their understanding and, if capable, the participant should sign and date the informed consent form or assent form as appropriate.
