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F.r.4 and F.r.5 Are Not Populated Correctly in HL7 for Non Numeric Values and Value = 0 (Doc ID 2507116.1)

Last updated on JUNE 15, 2021

Applies to:

Oracle Argus Interchange - Version 8.1.2 and later
Information in this document applies to any platform.


Oracle Argus Safety Version 8.1.2

Issue regarding E2B Report Submissions in R3 Format.

Noted that F.r.4 and F.r.5 are not populated correctly if the fields have non numeric data value.

This issue is already described in Bug 27564255 which is solved in Argus 8.2 by implementing the workaround given in Doc ID 2376522.1.

However,  the same error also happens if the case value for normal high or normal low is "0" (zero).

xsi:type should be PQ for normal low or normal high = 0. ED is not correct.

That scenario is not covered by above mentioned workaround, also a new conformance rule to not allow 0 would not be an acceptable workaround since 0 is a valid number and it makes sense to use it as a value for Normal High and Normal Low.

Thus currently not able to submit cases to EMA if the Normal High or Normal Low is "0". 

Is this a known issue and if yes, any workaround ?



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