Creating Custom or Non-Standard CDISC SDTM Domains
Here is the nice article about creating custom SDTM domains......... Creating Custom or Non-Standard CDISC SDTM Domains Within the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) , standard domains are split into four main types: special purpose, relationships, trial design and general observation classes. General observation classes cover the majority of observations collected during a study and can be divided among three general classes: The Interventions class captures investigational , therapeutic and other treatments that are administered to the subject (with some actual or expected physiological effect) either as specified by the study protocol (e.g., “exposure”), coincident with the study assessment period (e.g., “concomitant medications”), or other substances self-administered by the subject (such as alcohol, tobacco, or caffeine). The Events class captures planned protocol milestones such as randomization and study co...