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Reference:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020 10.7 (e): Difference between revisions

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{{#set:
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|has_document=Document:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020
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|tags_display=[[Glossary:TAG-00292-Eme-ent|Emergency unblinding]], [[Glossary:TAG-00123-Bli-ppe|Blinding]], [[Glossary:TAG-00031-Pat-onA|Patient information sheet]], [[Glossary:TAG-00201-Cli-eSt|Clinical investigation]]
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== Document Information ==
{{:Document:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020}}
== Reference Details ==
{| class="wikitable" style="width:100%;"
|-
! scope="row" style="width:200px;" | Scope
| MD
|-
! scope="row" style="width:200px;" | Document part
| 10.7
(e)
|-
! 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
| Subject information on emergency procedures related to trial
|}
== Text ==
[...]
e) provide the subject with [...]

Latest revision as of 13:49, 16 July 2026



Document information
Reference ISO ISO 14155 -

Clinical investigation of medical devices for human subjects 2020

Validity area ISO
Scope(s) MD
Document name ISO 14155 -

Clinical investigation of medical devices for human subjects

Version / Revision 2020
Status Current
Document type International guideline
Language(s) EN
Description ISO 14155:2020

Clinical investigation of medical devices for human subjects — Good clinical practice

Official source Official link
Restricted access Yes
Submitted by Florian Adragna
Contributors


Reference Details
Module Module 3 — Unit 3.3.1
Scope MD
Document part 10.7

(e)

Language EN
Original entry by Florian Adragna
Contributors
Tags Emergency unblinding, Blinding, Patient information sheet, Clinical investigation

Content

[...] e) provide the subject with [...]

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