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Reference:EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022 Page 6: Difference between revisions

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{{#set:
{{ReferenceData
|HasDocument=Document:EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022
|has_document=Document:EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022
|RefScope=G
|module=3
|RefDocPart=Page 6
|unit=3.1.1
|RefLanguage=EN
|scope=G
|RefTagsEN=
|doc_part=Page 6
|RefTagsOriginal=
|language=EN
|RefTagsFR=
|entry_by=Florian Adragna
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|contributors=
 
|tags=TAG-00032-Inf-ngs ++ TAG-00343-Doc-ten ++ TAG-00150-Sou-eUr ++ TAG-00112-Ass-nve ++ TAG-00029-Inf-rte
== Document Information ==
|tags_display=[[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]]
{{:Document:EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022}}
|comment=Need of documentation of the Informed Consent Process in Source records
 
|content=[…]
== Reference Details ==
{| class="wikitable" style="width:100%;"
|-
! scope="row" style="width:200px;" | Scope
| G
|-
! scope="row" style="width:200px;" | Document part
| Page 6
|-
! scope="row" style="width:200px;" | Language
| EN
|-
! scope="row" style="width:200px;" | Original entry by
| Florian Adragna
|-
! scope="row" style="width:200px;" | Contributors
|  
|-
! scope="row" style="width:200px;" | Tags (EN)
|  
|-
! scope="row" style="width:200px;" | Tags (original language)
|
|-
! scope="row" style="width:200px;" | Tags (FR)
|  
|-
! scope="row" | Comment
| Need of documentation of the Informed Consent Process in Source records
|}
 
== Text ==
[…]
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.
[…]
[…]
}}

Latest revision as of 13:49, 16 July 2026



Document information
Reference EU EMA/INS/GCP/143492/2022

- ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022

Validity area EU
Scope(s) G
Document name EMA/INS/GCP/143492/2022

- ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE

Version / Revision 2022
Status Current
Document type Official guideline
Language(s) EN
Description EMA/INS/GCP/143492/2022

Good Clinical Practice Inspectors Working Group (GCP IWG)

ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: 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 Page 6
Language EN
Original entry by Florian Adragna
Contributors
Tags Consent process, Documentation, Source documents, Assent, Informed consent

Content

[…] 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. […]

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