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
Original or Prior WHODrug Coding Variables
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