Document:EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017
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 | |
References
| Reference | Scope | Document part | Language | Preview |
|---|---|---|---|---|
| Reference:EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017 4. | G | 4. | EN | 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 ... |
