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 | |
|---|---|
| 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 |
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
