Reference:ICH ICH E11 Guideline R1 (2017) 8
From GxPlex
| Document information | |
|---|---|
| Reference | ICH ICH E11 Guideline R1 (2017) |
| Validity area | ICH |
| Scope(s) | G |
| Document name | ICH E11 Guideline |
| Version / Revision | R1 (2017) |
| Status | Current |
| Document type | International guideline |
| Language(s) | EN |
| Description | CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS IN THE PEDIATRIC POPULATION |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Scope | G |
| Document part | 8 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | Parental consent, assent and guardian definitions |
Content
8. GLOSSARY
Parental (legal guardian) consent/permission: Expression of understanding and agreement by fully informed parent(s) or legal guardian to permit the investigator/sponsor of a clinical study to enroll a child in a clinical investigation. The choice of the terms parental consent or parental permission in different regions may reflect local legal/regulatory and ethical considerations.
Child assent: The affirmative agreement of a child to participate in research or to undergo a medical intervention. Lack or absence of expression of agreement or disagreement must not be interpreted as assent.
