Personal tools

Sponsorname

Your company could advertise here

www.fla-consulting.eu

Reference:EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 2.5-002: Difference between revisions

From GxPlex

Jump to: navigation, search
m 1 revision imported
gxplex>GxPlexBot
Import from GxPlex Excel
Line 9: Line 9:
}}
}}


== Document Information ==
{{:Document:EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022}}
{{:Document:EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022}}


== Reference Details ==
{| class="gplx-infobox"
{| class="wikitable" style="width:100%;"
|-
|-
! scope="row" style="width:200px;" | Scope
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Scope
| G
| G
|-
|-
! scope="row" style="width:200px;" | Document part
! Document part
| 2.5
| 2.5
|-
|-
! scope="row" style="width:200px;" | Language
! Language
| EN
| EN
|-
|-
! scope="row" style="width:200px;" | Original entry by
! Original entry by
| Florian Adragna
| Florian Adragna
|-
|-
! scope="row" style="width:200px;" | Contributors
! Contributors
|  
|  
|-
|-
! scope="row" style="width:200px;" | Tags (EN)
! Tags (EN)
|  
|  
|-
|-
! scope="row" style="width:200px;" | Tags (original language)
! Tags (original language)
|  
|  
|-
|-
! scope="row" style="width:200px;" | Tags (FR)
! Tags (FR)
|  
|  
|-
|-
! scope="row" | Comment
! Comment
| Repeated entry: 4.5.2 ++ 2.4.0
| Repeated entry: 4.5.2 ++ 2.4.0


Line 45: Line 45:
|}
|}


== Text ==
== Content ==
2.5. Personnel
2.5. Personnel
Points to consider:
Points to consider:

Revision as of 14:27, 29 June 2026



Document information
Reference EU EMA/786433/2022

Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022

Validity area EU
Scope(s) G
Document name EMA/786433/2022

Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units

Version / Revision 15-Nov-2022
Status Current
Document type Official guideline
Language(s) EN
Description EMA/786433/2022

Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units

Official source Official link
Restricted access No
Submitted by Florian Adragna
Contributors


Reference Details
Scope G
Document part 2.5
Language EN
Original entry by Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment Repeated entry: 4.5.2 ++ 2.4.0

Personnel requirements: investigator-sponsor relationship

Content

2.5. Personnel Points to consider: […] • Relationship of the Investigator with the Sponsor company. […]