Best Practices for reporting CT cases with Serious Adverse Reaction not related to IMP
(Doc ID 2505579.1)
Last updated on FEBRUARY 07, 2022
Applies to:Oracle Argus Safety - Version 7.0.5 and later
Oracle Argus Interchange - Version 7.0.5 and later
Information in this document applies to any platform.
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:
|Reference||E2B(R2) / (R3) requirements|
|ICH-E2B(R2)||Data element A.1.4 ‘Type of report’ should be populated with the value ‘Spontaneous’|
|ICH-E2B(R3)||Data element C.1.3 ‘Type of report’ should be populated with the value ‘Spontaneous’|
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