REACTIONENDDATER3 [E.i.5] Should be Transmitted Irrespective of REACTIONOUTCOME [E.i.7] for MFDS E2B
(Doc ID 2855281.1)
Last updated on MARCH 14, 2022
Applies to:Oracle Argus Safety - Version 8.2.3 and later
Information in this document applies to any platform.
As per the Ministry of Food and Drug Safety (MFDS) guidelines, MFDS Domestic Clinical Trial (CT) cases should have a stop date as Null Flavor in case of Event Outcome as Not Recovered/Not Resolved.
However, when generating an MFDS R3 report using an Out of the Box (OOTB) MFDS profile from Argus version 8.2.3, then tag E.i.5 (reactionenddate3) is not showing up in the R3 XML report.
In decoded view, it is possible to see E.i.4 (reactionstartdateR3) but in HL7 view it does not show that tag data.
To view full details, sign in with your My Oracle Support account.
Don't have a My Oracle Support account? Click to get started!
In this Document