Causality Source and Causality Result Values Checked By EMA R2 Profile
(Doc ID 2496043.1)
Last updated on JULY 13, 2023
Applies to:
Oracle Life Sciences Argus Safety - Version 8.1.2 to 8.1.2 [Release 8.1]Information in this document applies to any platform.
Goal
EMA R2 Profile checks Causality Source and Causality Result values at ICSR generation for B.4.k.18 element.
Oracle Argus Interchange E2B (R2) Interchange Export Mapping Document Version 8.1.2 E93485-01 February 2018
user's manual (8.1.2 eTRM ArgusInterchange_E2B(R2)ExportMappings.xlsx file) has the following description on its [Validation-EMA] tab:
Additional Notes on Validation rules
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Mandatory for EVCTM cases that has C.1.3[REPORTTYPE] = 2 and C.5.4[OBSERVESTUDYTYPE] = 1.
Each product and event combination in Event assessment must have at least one record for As reported or As company data entered containing below data:
1. valid Causality source (allowed values are 1, 2, or 3),
2. valid Causality result (allowed values are 1 or 2)
Note: When valid source and result is available, mapping logic automatically takes care of populating method as EVCTM
Where do the Causality Source and Causality Result values exist which EMA R2 Profile checks?
Solution
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In this Document
| Goal |
| Solution |