Unable To Amend Conformance Rules for R3 XM On a Custom Profile i.e. For Non-related Cases
(Doc ID 2628373.1)
Last updated on MARCH 12, 2021
Applies to:Oracle Argus Interchange - Version 8.1.2 and later
Information in this document applies to any platform.
Generating R3 XML for non-related cases
Need to generate R3 XML for cases where all events are non-related without validation warnings.
In the default shipped Argus profile ICH-ICSR V3.0 MESSAGE TEMPLATE - EMA this raises a validation error:
Thus a copy of the profile was created and the conformance rule for the element EUDRUGRESULT which are causing the above validation error were unable to be deleted.
Request confirmation that the option to delete should be enabled when selecting Conformance Rules - Additional Validations. The button is always greyed out and not available for action.
Steps to Reproduce:
- AS 8.1.2
- Create a Case in Argus User Interface (UI) that has Report Type of 'Sponsored Trial'
- Select a simple Unblinded Study
- Add 1 Event i.e. 'Hives'
- Navigate via [Event] - [Event Assessment]
- Set As Reported / As Determined / Other Causality all to 'Not Related'
- Complete all other required E2B fields for case.
- Schedule an R3 E2B to Agency using shipped OOTB R3 EMA profile
i.e. ICH-ICSR V3.0 MESSAGE TEMPLATE - EMA
On Generation/Validation also get:
G.k.9.i.2.r.3.EU.1 - EUDRUGRESULT
Case Form / Events / Event Assessment / Causality as Reported, Causality Determined, Other Causality - Result
Value of G.k.9.i.2.r.3.EU.1[EUDRUGRESULT] = 1 should exist for at least one Suspect/Interacting product and at least one of the event reported in the ICSR for cases sent to EVCTM.
2 G.k.9.i.2.r.2.EU.1 - EUDRUGASSESSMENTMETHOD
Case Form / Events / Event Assessment / Causality as Reported, Causality Determined, Other Causality – Method
Value of G.k.9.i.2.r.2.EU.1[EUDRUGASSESSMENTMETHOD] = 1 should exist along with G.k.9.i.2.r.3.EU.1[DRUGRESULT] for each Suspect/Interacting product and each event reported in the
ICSR for cases sent to EVCTM.
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