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

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Risk proportionate approaches in clinical trials  25-Apr-2017
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Risk proportionate approaches in clinical trials
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|DocDescription=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
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|DocSubmittedBy=Florian Adragna
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|reference=EU  Recommendations of the expert group -  
Risk proportionate approaches in clinical trials  25-Apr-2017
Risk proportionate approaches in clinical trials  25-Apr-2017
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== References ==
{| class="wikitable" style="width:100%;"
! Reference !! Scope !! Document part !! Language !! Preview
|-
| [[Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 2.]] || HM || 2. || EN || [...] The risk to subject safety in a clinical trial mainly stems from two sources: the IMP and the trial procedures. For example, if a clinical trial is considered low intervention from an IMP ...
|-
| [[Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.1]] || HM || 4.1 || EN || 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 ...
|-
| [[Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.5]] || HM || 4.5 || EN || 4.5. Trial documentation Content of the Trial Master File (TMF) […] Examples of how risk-adaptation could affect the TMF include the following: - combining of documents: one document serves multiple ...
|-
| [[Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.4]] || HM || 4.4 || EN || 4.4. Trial management Monitoring Monitoring activities should focus on preventing or mitigating important and likely sources of error in the conduct, collection, and reporting of critical data and ...
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Latest revision as of 14:15, 16 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

References

 ScopeDocument partLanguagePreview
EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 2.HM2.EN[...] The risk to subject safety in a clinical trial mainly stems from two sources: the IMP and the trial procedures. For example, if a clinical trial…
EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.1HM4.1ENA risk based quality management system for clinical trials should include the following steps:

- critical process and data identification

- risk ident…
EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.4HM4.4EN4.4. Trial management

Monitoring

Monitoring activities should focus on preventing or mitigating important and likely sources of error in the conduct, …
EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 4.5HM4.5EN4.5. Trial documentation

Content of the Trial Master File (TMF) […] Examples of how risk-adaptation could affect the TMF include the following:

- comb…
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