Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 2.
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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 | |
|---|---|
| Scope | HM |
| Document part | 2. |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | Risk sources in clinical trials: IMP and trial procedures |
Content
[...] 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 perspective, it does not mean that all other risks associated with this trial are low as well. Other risks could be related to the trial design, the clinical procedures specified in the protocol, the patient population, the informed consent process etc. These risks should also be assessed and mitigated where appropriate (see section 4.1.). Equally if a trial is not low intervention, this does not mean that risk proportionate procedures cannot or should not be applied.
