Allow Removal of Unrelated Study Medication Information for a Post-Marketing Report
(Doc ID 2486296.1)
Last updated on FEBRUARY 26, 2019
Applies to:Oracle Argus Safety - Version 7.0.5 and later
Information in this document applies to any platform.
Oracle Argus Safety Version 7.0.5
In the situation when a serious adverse event (SAE) is recorded in a interventional clinical trial but the investigator has indicated that the SAE was due to non-study medication only, and there was no relationship to the study medication – the resulting expedited report should be sent to the post-marketing module of Eudravigilance as a spontaneous report
When coding this case in Argus, whilst an XML can be created to the post-marketing module – Users are unable to remove details of the study medication as suspect medication in the XML even though it was not implicated.
GVP chapter VI published by the European medicines agency clearly states that in this example the case should be sent as a spontaneous report however the current OOTB Argus functionality does not allow this happen as unable to remove study medication from the xml or demote it to a concomitant medication.
This issue is causing concern to regulators who are looking at the post-marketing information from a signal detection perspective and seeing study medications coded as suspect when not expected
Request change to the Out Of The Box functionality
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