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Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.1: Difference between revisions

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== Document Information ==
{{:Document:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017}}
{{:Document:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017}}


== Reference Details ==
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| HM
| HM
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|-
! scope="row" style="width:200px;" | Document part
! Document part
| 4.1
| 4.1
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|-
! scope="row" style="width:200px;" | Language
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| 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)
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! scope="row" style="width:200px;" | Tags (original language)
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! scope="row" style="width:200px;" | Tags (FR)
! Tags (FR)
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! scope="row" | Comment
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| Risk-based quality management system for clinical trials
| Risk-based quality management system for clinical trials
|}
|}


== Text ==
== Content ==
A risk based quality management system for clinical trials should include the following steps:
A risk based quality management system for clinical trials should include the following steps:
- critical process and data identification
- critical process and data identification

Revision as of 14:27, 29 June 2026



Document information
Reference EU Recommendations of the expert group -

Risk proportionate approaches in clinical trials 25-Apr-2017

Validity area EU
Scope(s) HM
Document name Recommendations of the expert group -

Risk proportionate approaches in clinical trials

Version / Revision 25-Apr-2017
Status Current
Document type Official recommendation
Language(s) EN
Description Risk proportionate approaches in clinical trials

Recommendations of the expert group on clinical trials for the implementation of Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use

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


Reference Details
Scope HM
Document part 4.1
Language EN
Original entry by Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment Risk-based quality management system for clinical trials

Content

A risk based quality management system for clinical trials should include the following steps: - critical process and data identification - risk identification - risk evaluation - risk control - risk communication - risk review - risk reporting

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