Reference:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 2.

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)
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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.