Original or Prior Coding Variables

Keeping original coding variables is not common, but there are a couple of instances where it might be helpful:

• When a study is mapped to one version of a mapping dictionary for an interim analysis and another for final analysis
• When studies using different versions of a mapping dictionary are pooled together for an integrated analysis

Because the dictionary-coded values may change with each version, counts for study tables can differ between versions for the same study. Therefore, keeping the original variables provides traceability to original (or prior) analysis(es).

The variables described below provide traceability to original (or prior) analysis(es). The suffix “w” represents an integer (1-9) corresponding to a previous version. Include the dictionary name and version as part of the metadata for each variable.These variable names at this time are recommendations only. Additional prior or original variables needed for traceability may be added following the same conventions. There is an ADaM subteam working on integration, and this group may create different naming conventions for that type of analysis.

Original or Prior MedDRA Coding Variables

Variable Name	Variable Label	Type	Codelist/ Controlled Terms	Core	CDISC Notes
DECDORGw	PT in Original Dictionary w	Char	MedDRAw	Perm	Original preferred term coding of XX.--TERM using MedDRA or other dictionary version X.X
BDSYORGw	SOC in Original Dictionary w	Char	MedDRAw	Perm	Original body system coding of XX.--TERM using MedDRA or other dictionary version X.X
HLGTORGw	HLGT in Original Dictionary w	Char	MedDRAw	Perm	Original HLGT coding of XX.--TERM using MedDRA or other dictionary version X.X
HLTORGw	HLT in Original Dictionary w	Char	MedDRAw	Perm	Original HLT coding of XX.--TERM using MedDRA or other dictionary version X.X
LLTORGw	LLT in Original Dictionary w	Char	MedDRAw	Perm	Original LLT coding of XX.--TERM using MedDRA or other dictionary version X.X
LLTNORGw	LLT Code in Original Dictionary w	Char	MedDRAw	Perm	Original LLT code of XX.--TERM using MedDRA or other dictionary version X.X

Variable Name	Variable Label	Type	Codelist	Controlled Terms^a	Core	SubClass ADVERSE EVENT Core	CDISC Notes
DECDORGw	PT in Original Dictionary w	Char		MedDRAw	Perm	Perm	Original preferred term coding of XX.--TERM using MedDRA or other dictionary version X.X.
BDSYORGw	SOC in Original Dictionary w	Char		MedDRAw	Perm	Perm	Original body system coding of XX.--TERM using MedDRA or other dictionary version X.X.
HLGTORGw	HLGT in Original Dictionary w	Char		MedDRAw	Perm	Perm	Original HLGT coding of XX.--TERM using MedDRA or other dictionary version X.X
HLTORGw	HLT in Original Dictionary w	Char		MedDRAw	Perm	Perm	Original HLT coding of XX.--TERM using MedDRA or other dictionary version X.X.
LLTORGw	LLT in Original Dictionary w	Char		MedDRAw	Perm	Perm	Original LLT coding of XX.--TERM using MedDRA or other dictionary version X.X.
LLTNORGw	LLT Code in Original Dictionary w	Char		MedDRAw	Perm	Perm	Original LLT code of XX.--TERM using MedDRA or other dictionary version X.X.

Original or Prior WHO Drug Coding Variables

Variable Name	Variable Label	Type	Codelist/ Controlled Terms	Core	CDISC Notes
DECDORGw	Standardized Med Name in Orig Dict w	Char	WHODRUGw	Perm	Original standardized medication name of CM.CMTRT using WHO Drug version X.X
CLASORGw	Medication Class in Orig Dictionary w	Char	WHODRUGw	Perm	Original medication class of CM.CMTRT using WHO Drug version X.X
CLCDORGw	Medication Class Code in Orig Dict w	Char	WHODRUGw	Perm	Original medication class code of CM.CMTRT using WHO Drug version X.X
ATyCORGw	ATC Level y Code in Orig Dictionary w	Char	WHODRUGw	Perm	Original ATC Level y code of CM.CMTRT using WHO Drug version X.X
ATyTORGw	ATC Level y Text in Orig Dictionary w	Char	WHODRUGw	Perm	Original ATC Level y text of CM.CMTRT using WHO Drug version X.X

Variable Name	Variable Label	Type	Codelist	Controlled Terms	Core	SubClass ADVERSE EVENT Core	CDISC Notes
DECDORGw	Standardized Med Name in Orig Dict w	Char		WHODRUGw	Perm	Perm	Original standardized medication name of CM.CMTRT using WHO Drug version X.X
CLASORGw	Medication Class in Orig Dictionary w	Char		WHODRUGw	Perm	Perm	Original medication class of CM.CMTRT using WHO Drug version X.X
CLCDORGw	Medication Class Code in Orig Dict w	Char		WHODRUGw	Perm	Perm	Original medication class code of CM.CMTRT using WHO Drug version X.X
ATyCORGw	ATC Level y Code in Orig Dictionary w	Char		WHODRUGw	Perm	Perm	Original ATC Level y code of CM.CMTRT using WHO Drug version X.X
ATyTORGw	ATC Level y Text in Orig Dictionary w	Char		WHODRUGw	Perm	Perm	Original ATC Level y text of CM.CMTRT using WHO Drug version X.X

Page tree

Original or Prior Coding Variables