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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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Revision as of 17:29, 15 July 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
Module Module 1 — Unit 1.2.7
Scope HM
Document part 4.1
Language EN
Original entry by Florian Adragna
Contributors
Tags Risk-based quality management, Quality management system, Risk
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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