When processing XML-based
standards (such as CDISC ODM, CDISC CRT-DDS, and CDISC Define-XML
), 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 file (CDISC
ODM 1.3.0, CDISC ODM 1.3.1, CDISC ODM controlled terminology, CDISC
Define-XML 2.0, or CDISC CRT-DDS 1.0 XML [define.xml]) 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 Define-XML
2.0, there are 46 data sets (such as ItemDefs) containing 215 columns
that are derived from the define.xml element and attribute structure.
For the CDISC Analysis Results Metadata extension for Define-XML 2.0,
the SAS representation was extended to 54 data sets containing 239
columns.
For CDISC ODM 1.3.0,
there are 66 data sets containing 315 columns in the SAS representation
of the model.
For ODM 1.3.1, there
are 76 data sets containing 352 columns in the SAS representation
of the model.
For CDISC CT 1.0, there
are 15 data sets containing 73 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 or CDISC ADaM) and can include supporting metadata from
other sources. The SAS Clinical Standards Toolkit can create a CDISC
CRT-DDS 1.0 XML file, a CDISC Define-XML 2.0 file (including Analysis
Results Metadata), a CDISC ODM 1.3.0 file, a CDISC ODM 1.3.1 XML file,
a Dataset-XML 1.0 file, or a CDISC CT XML 1.0 file.