Reference:EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017 4.: Difference between revisions
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{{:Document:EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017}} | {{:Document:EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017}} | ||
{| class="gplx-infobox" | |||
{| class=" | |||
|- | |- | ||
! | ! colspan="2" class="gplx-infobox-header" | Reference Details | ||
|- | |||
! Scope | |||
| G | | G | ||
|- | |- | ||
! | ! Document part | ||
| 4. | | 4. | ||
|- | |- | ||
! | ! Language | ||
| EN | | EN | ||
|- | |- | ||
! | ! Original entry by | ||
| Florian Adragna | | Florian Adragna | ||
|- | |- | ||
! | ! Contributors | ||
| | | | ||
|- | |- | ||
! | ! Tags (EN) | ||
| | | | ||
|- | |- | ||
! | ! Tags (original language) | ||
| | | | ||
|- | |- | ||
! | ! Tags (FR) | ||
| | | | ||
|- | |- | ||
! | ! Comment | ||
| Need of documentation of the Informed Consent Process in Source records | | Need of documentation of the Informed Consent Process in Source records | ||
|} | |} | ||
== | == Content == | ||
4. Informed consent of trial subjects | 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. | 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. | ||
Revision as of 14:27, 29 June 2026
| 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.
