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
From GxPlex
Gxplex admin (talk | contribs) m 1 revision imported |
imported>GxPlexBot Import from GxPlex Excel |
||
| Line 4: | Line 4: | ||
|RefDocPart=4. | |RefDocPart=4. | ||
|RefLanguage=EN | |RefLanguage=EN | ||
| | |RefTags=TAG-00032-Inf-ngs ++ TAG-00343-Doc-ten ++ TAG-00150-Sou-eUr ++ TAG-00112-Ass-nve ++ TAG-00029-Inf-rte | ||
| | |RefModule=3 | ||
| | |RefUnit=3.1.1 | ||
}} | }} | ||
| Line 14: | Line 14: | ||
|- | |- | ||
! colspan="2" class="gplx-infobox-header" | Reference Details | ! colspan="2" class="gplx-infobox-header" | Reference Details | ||
|- | |||
! Module | |||
| Module 3 — Unit 3.1.1 | |||
|- | |- | ||
! Scope | ! Scope | ||
| Line 30: | Line 33: | ||
| | | | ||
|- | |- | ||
! Tags | ! Tags | ||
| | | [[Glossary:TAG-00032-Inf-ngs|Consent process]], [[Glossary:TAG-00343-Doc-ten|Documentation]], [[Glossary:TAG-00150-Sou-eUr|Source documents]], [[Glossary:TAG-00112-Ass-nve|Assent]], [[Glossary:TAG-00029-Inf-rte|Informed consent]] | ||
|- | |||
| | |||
|- | |||
| | |||
|- | |- | ||
! Comment | ! Comment | ||
Revision as of 17:29, 15 July 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 | |
|---|---|
| Module | Module 3 — Unit 3.1.1 |
| Scope | G |
| Document part | 4. |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Consent process, Documentation, Source documents, Assent, Informed consent |
| 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.
