CDISC standards allow
for the inclusion and exclusion of some columns. (For example, timing
variables can be included or excluded.) In addition, CDISC standards
do not specify a length for most columns. Therefore, any implementation
of a CDISC standard requires interpretation of that standard. This
interpretation might lead to differences in the implementation of
that standard. Reference standards are derived based on internal conventions
and experiences, and discussions with regulatory authorities.
The domain and column
metadata that constitute the SAS representation of CDISC SDTM 3.1.1
are derived from the global standards library in these formats:
-
as empty data sets (using the utility
macro cst_createTablesForDataStandard)
-
as table metadata (reference_tables
in the standard metadata folder)
-
as column metadata for each domain
(reference_columns in the standard metadata folder)
The SAS Clinical Standards
Toolkit CDISC SDTM reference standard provides metadata and code to
validate the structure and content of the SDTM domains.
To enable validation,
supplemental files supporting SDTM validation processes include these
global standards library files:
-
The Validation Master data set
in the
validation/control folder contains
the super-set of checks validating domain structure and content.
-
The Messages data set in the
messages folder provides error messaging for all
Validation Master checks.
-
SAS code in the
macros folder provides code specific to SDTM that
augments code that is provided in the primary SAS Clinical Standards
Toolkit autocall library (
!sasroot/cstframework/sasmacro).
It is this set of files,
in whole or in part, that defines the CDISC SDTM reference standard.