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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:

E2B(R2) / (R3) Requirements
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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