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. SAS Clinical Standards Toolkit
1.3 reads a CDISC ODM 1.3.0 or a CDISC CRT-DDS 1.0 XML file and converts
the information into a SAS data set 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. 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. SAS Clinical Standards
Toolkit 1.3 can also create a CDISC CRT-DDS 1.0 XML file.