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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

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|comment=Repeated entry: 4.5.2 ++ 2.4.0
{| class="wikitable gplx-infobox"
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Module
| Module 4 — Unit 4.5.2
|-
! Scope
| G
|-
! Document part
| 2.5
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
|
|-
! Tags
| [[Glossary:TAG-00018-Inv-die|Investigator]], [[Glossary:TAG-00017-Spo-die|Sponsor]], [[Glossary:TAG-00340-Req-nfo|Requirements]]
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! Comment
| Repeated entry: 4.5.2 ++ 2.4.0


Personnel requirements: investigator-sponsor relationship
Personnel requirements: investigator-sponsor relationship
|}
|content=2.5. Personnel
 
== Content ==
2.5. Personnel
Points to consider:
Points to consider:
[…]
[…]
• Relationship of the Investigator with the Sponsor company.
• Relationship of the Investigator with the Sponsor company.
[…]
[…]
}}

Latest revision as of 13:50, 16 July 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
Module Module 4 — Unit 4.5.2
Scope G
Document part 2.5
Language EN
Original entry by Florian Adragna
Contributors
Tags Investigator, Sponsor, Requirements

Content

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

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