13 Regional Causality Assessment (G.k.9.i) for post-marketed Domestic cases and Study cases
There are 3 regional KR elements described for Regional Causality Assessment.
For CT or CU cases, it is mandatory to transmit KRMETHODOFASSESSMENT [G.k.9.i.2.r.2.KR.1] and KRCTRESULTOFASSESSMENT [G.k.9.i.2.r.3.KR.2].
For Post-marketed Domestic cases, preference is given to Regional causality elements over ICH standard causality elements: KRMETHODOFASSESSMENT [G.k.9.i.2.r.2.KR.1] and WHOUMCRESULTOFASSESSMENT [G.k.9.i.2.r.3.KR.1].
Element ID | Element description | Allowed Values |
---|---|---|
G.k.9.i.2.r.2.KR.1 | MFDS Method of Assessment | 1=WHO-UMC
2=KRCT |
G.k.9.i.2.r.3.KR.1 | WHO-UMC Result of Assessment | 1 = Certain
2 = Probable 3 = Possible 4 = Unlikely 5 = Conditional/unclassified 6 = Unassessable/unclassifiable nullFlavor: NA |
G.k.9.i.2.r.3.KR.2 | KRCT Result of Assessment | 1 = Related
2 = Unrelated |
To achieve this, Oracle Argus Safety Flexible code list is enhanced with additional values in Console > Code Lists > Flexible re-categorization > CAUSALITY_CATEGORY:
- The new MFDS attribute is added.
- The existing E2B(R3) attribute is updated for the additional values.
When a Medical Reviewer assesses Case Form > Event > Event Assessment > Causality as Reported Result and Causality as Determined Result, the MFDS specific codes are populated by out-of-the-box mapping logic in Regional Causality Assessment elements.
Note:
For Null flavor [NA], configure a flex code list with MFDS code as [NA]. This is not provided out-of-the-box.For details, refer to the Business Rules defined in the E2B(R3) export mapping document.
What this means to business users: No additional data entry required (and derived from existing Causality Result).
CODE | En | REPORTABILITY | Ja | EU_CODE | MFDS |
---|---|---|---|---|---|
1 | Almost Certain | 1 | 1 | 1 | |
2 | Probable | 1 | 1 | 2 | |
3 | Possible | 1 | 1 | 3 | |
4 | Unlikely | 0 | 2 | 4 | |
5 | Not Related | 0 | 2 | 4 | |
6 | Unknown | 1 | 1 | 5 | |
7 | Not Reported | 1 | 1 | 6 | |
8 | None | 0 | 2 | 6 |