ICSR E2B R3 Is Not Generated Due To Conformance Rules Issue With Lab Tests
(Doc ID 2499009.1)
Last updated on DECEMBER 18, 2024
Applies to:
Oracle Life Sciences Argus Safety - Version 8.1.2 and laterInformation in this document applies to any platform.
Symptoms
On Applications Oracle Life Sciences 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.
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 |