CDSIC SDTM Standards (3)

Creating new domain

1. Confirm that none of the existing published domains will fit the need. A custom domain may only be created if the data are different in nature and do not fit into an existing published domain.
2. Check the Submission Data Standards in SDTM IG for the general rules of creating variables
3.  Look for an existing, relevant domain model to serve as a prototype. If no existing model seems appropriate, choose the general observation class (Interventions, Events, or Findings) that best fits the data by considering the topic of the observation

General Conventions for SDTM Modeling

Ø        For dates, Findings domains use xxDTC while Interventions

                      and Events domains use xxSTDTC/xxENDTC.

Ø       User-defined domains are named XX format.

Ø      The position of the variables as per SDTM IG

Ø      Handling of “Other, specify” situations

•         If only 1 response, put into SUPPxx

•         If > 1 response, consider FA domain (if Findings data) and other options