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Nullflavor MSK Cannot Be Entered Into Fields For D.1.1.x - Failure To Import/transmit E2BR3 (Doc ID 2517417.1)

Last updated on JULY 13, 2023

Applies to:

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

Symptoms

On Applications Oracle Argus Safety Version : 8.1.2

According to E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide – Data Elements and Message Specification nullflavor "MSK" is acceptable for the following:

• D.1.1.1 Patient Medical Record Number(s) and Source(s) of the Record Number (GP Medical Record Number)
• D.1.1.2 Patient Medical Record Number(s) and Source(s) of the Record Number (Specialist Record Number)
• D.1.1.3 Patient Medical Record Number(s) and Source(s) of the Record Number (Hospital Record Number)
• D.1.1.4 Patient Medical Record Number(s) and Source(s) of the Record Number (Investigation Number)



However via the Argus UI it is not possible to enter a Nullflavor for these fields.


In turn if value MSK is received in above fields via import of incoming E2B R3 file will not import.

When these are the only available patient identifiers for the case from R3 E2B perspective this is considered an Invalid case, since Argus validation checks prevent re-transmission of the ICSR.

Error Details Are:

Value of at least one of the below element should exist D.1[PATIENTINITIAL] or MSK D.1.1.1[PATIENTGPMEDICALRECORDNUMB] D.1.1.2[PATIENTSPECIALISTRECORDNUMB] D.1.1.3[PATIENTHOSPITALRECORDNUMB] D.1.1.4[PATIENTINVESTIGATIONNUMB] D.2.1[PATIENTBIRTHDATER3] with minimum precision of 'CCYYMMDD' D.2.2a[PATIENTONSETAGE] D.2.2.1a[GESTATIONPERIOD] D.2.3[PATIENTAGEGROUP] D.5[PATIENTSEXR3]



NullFlavor is regarded as having no data and fails the mandatory validation except for MSK supported for D.1.


Steps

Attempt to Import or enter nullflavor 'MSK' into a field corresponding to D.1.1.x:

- Patient Information/subject number
- References/E2B GP number
- References/E2B Specialist number
- References/E2B Hospital number

Note that currently these fields cannot hold nullflavor



Cause

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In this Document
Symptoms
Cause
Solution
References


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