Reference:EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017 4.
From GxPlex
| Document information | |
|---|---|
| Reference | EU EMA/431265/2016
Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017 |
| Validity area | EU |
| Scope(s) | G |
| Document name | EMA/431265/2016
Annex I – to guidance for the conduct of good clinical practice inspections – investigator site |
| Version / Revision | 06-Sep-2017 |
| Status | Current |
| Document type | Official guideline |
| Language(s) | EN |
| Description | EMA/431265/2016
Annex I – to guidance for the conduct of good clinical practice inspections – investigator site |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Scope | G |
| Document part | 4. |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | Need of documentation of the Informed Consent Process in Source records |
Content
4. Informed consent of trial subjects […] Documentation in the source data of the process of obtaining the initial informed consent and subsequent consent to updates, including paediatric assent and emergency consent, if applicable.
