CDISC standards, including
SDTM, 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, which 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 each CDISC SDTM
standard are derived from the global standards library in these formats:
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as empty data sets (using the utility
macro cst_createTablesForDataStandard)
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Sample reference_tables Record (CDISC SDTM 3.1.1)
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Adverse Events SAS transport
file
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One record per event
per subject
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STUDYID USUBJID AETERM
AESTDTC
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Sample reference_columns Record (CDISC SDTM 3.1.1)
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The severity or intensity
of the event. Examples: MILD, MODERATE, SEVERE.
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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:
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The Validation Master data set
in the
validation/control folder contains
the superset of checks validating the domain structure and content
for each specific SDTM version.
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The Messages data set in the
messages folder
provides error messaging for all Validation Master checks.
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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 each of the CDISC SDTM reference
standards.