Best Practices for reporting CT cases with Serious Adverse Reaction not related to IMP (Doc ID 2505579.1)

Last updated on JULY 13, 2023

Applies to:

Goal

In the situation where a serious adverse event (SAE) is recorded in an interventional clinical trial and the investigator has indicated that the SAE was due to non-IMP or authorised AxMP only and there was no relationship to the IMPs – the resulting expedited report should be sent to the post-marketing module of EudraVigilance as a spontaneous report

GVP chapter VI published by the European Medicines Agency states the following:

“For clinical trial conducted in accordance with Directive 2001/20/EC and where the adverse reaction is only suspected to be related to a non-investigational medicinal product (or another medicinal product which is not subject to the scope of the clinical trial) and there is no interaction with the investigational medicinal product:

• The report should be considered as spontaneous report; as such it conveys the suspicion of the primary source;
• Inline with ICH-E2B the following applies:

Solution

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