Document:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017: 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 | |
References
| 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 ... |
