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 Study cases with C.1.3 Report Type = 2 (Report from Study), it is mandatory to transmit G.k.9.i.2.r.2.KR.1 MFDS Method of Assessment and G.k.9.i.2.r.3.KR.2 KRCT Result of Assessment.

For Post-marketed Domestic cases, preference is given to Regional causality elements over ICH standard causality elements: G.k.9.i.2.r.2.KR.1 MFDS Method of Assessment and G.k.9.i.2.r.3.KR.1 WHO-UMC Result of Assessment.

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