| Tiffany Bainter, Maddie Hays |
Splitting SDTM (Study Data Tabulation Model) domains into multiple datasets can serve as a valuable tool, streamlining
the process of creating and reviewing large, complex data domains.
In SDTM, a general observation class domain
may be split into separate datasets. In practice, we commonly split the Findings About (FA) and QS (Questionnaires)
domains.
Common reasons for dataset splitting include better representation of complex data, improved traceability
from Case Report Forms (CRF) to SDTM specifications to datasets, and simplified programming and
validation.
Domains can be split using several methods, including purpose, category, or time points.
Creating
complaint and consistent split domains can be supported by programming habits in SAS to organize and check your
data.
This paper will cover practical tips and FAQs such as, ensuring consistent variable naming across split datasets,
using unique identifiers (e.g., STUDYID, USUBJID,-SEQ) to link split datasets, updating the Define.XML file, CDISC
compliance queries, CRF annotation and SAS code examples. |