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ICSR E2B R3 Is Not Generated Due To Conformance Rules Issue With Lab Tests (Doc ID 2499009.1)

Last updated on APRIL 22, 2021

Applies to:

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

Symptoms

 On Applications Oracle Argus Safety Version : 8.1.2

An EMA R3 report for one case is not getting generated due to below error(s):


Case XXXXXXXX unspecified error (11) during ICSR generation.
Below are the draft report errors.

Conditional Mandatory
# ICSR Element ICSR Field Location Error Description
1 F.r.3.4 - TESTRESULTTEXT Case Form/Patient/Lab data/Notes Value of F.r.3.4[TESTRESULTTEXT] should exist if F.r.2.2b[TESTNAMELLT] is populated and both F.r.3.1[TESTRESULTCODE] and F.r.3.2[TESTRESULT] (with a valid F.r.3.3[TESTUNIT]) are not populated.
2 F.r.3.1 - TESTRESULTCODE Case Form/Patient/Lab Value of F.r.3.1[TESTRESULTCODE] should exist if F.r.2.2b[TESTNAMELLT] is populated data/Assessment and both F.r.3.2[TESTRESULT] (along with F.r.3.3[TESTUNIT]) and F.r.3.4[TESTRESULTTEXT] are not populated.
3 F.r.3.2 - TESTRESULT Case Form/Patient/Lab data/Result Value of F.r.3.2[TESTRESULT] (along iwth F.r.3.3[TESTUNIT]) should exist if
F.r.2.2b[TESTNAMELLT] is populated and both F.r.3.1[TESTRESULTCODE] and F.r.3.4[TESTRESULTTEXT] are not populated.



Cause

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In this Document
Symptoms
Cause
Solution


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