When processing XML-based
standards (such as CDISC ODM and CDISC CRT-DDS), the SAS Clinical
Standards Toolkit attempts to create a representation in SAS that
is based on the standard. This typically includes a combination of
metadata data sets, content data sets, and SAS format catalogs. Once
the standard is represented in SAS, additional processing in SAS,
such as model validation and reporting, is facilitated.
In general, when representing
an XML-based standard in SAS, an XML element is mapped to a SAS data
set, and its associated attributes are mapped to the columns of the
SAS data set. The SAS Clinical Standards Toolkit reads a CDISC ODM
1.3.0 or a CDISC CRT-DDS 1.0 XML file and converts the information
into a SAS representation of each model. For CDISC CRT-DDS 1.0, this
means that 39 data sets (such as ItemDefs) containing 176 columns
are derived from the define.xml element and attribute structure. For
CDISC ODM 1.3.0, there are 66 data sets containing 315 columns in
the SAS representation of the model. The SAS representation of each
standard can be derived in part from other standards (such as CDISC
SDTM) and can include supporting metadata from other sources. The
SAS Clinical Standards Toolkit can create both a CDISC CRT-DDS 1.0
XML file and a CDISC ODM 1.3.0 XML file.