Special Topic: Identifying Unsupported Elements and Attributes in a CDISC ODM File

In practice, vendor and custom extensions to ODM are common. For example, Electronic Data Capture (EDC) vendors use data management features and flags that might be exported using ODM XML extensions. By default, these extensions are ignored by the SAS Clinical Standards Toolkit. Recall that the SAS Clinical Standards Toolkit uses XSL style sheets for each of the default, supported 66 ODM data sets (such as ItemDefs). These style sheets look for specifically named tags and hierarchical paths based on the CDISC ODM 1.3.0 published specification. If elements or attributes exist in the XML file but not in the specification, they are ignored.

For example, in this XML code fragment, note the Vendor:<name> syntax. This represents a hypothetical extension to the ODM XML, presumably accompanied by a namespace reference supporting the Vendor naming convention.

<FormData FormOID=" FormDefs.OID.Death" FormRepeatKey="00-01"
             TransactionType="Remove" Vendor:Revised="No">
        <Vendor:DataQuery DQOID="DQ.OID.001"
                         QueryText="Premature report of patients demise?">
             <Flag>Y</Flag>
              <AuditRecord>
                <UserRef UserOID="User.OID.I024" />
                <LocationRef LocationOID="Location.OID.S001" />
                <DateTimeStamp>2011-01-24T15:13:22</DateTimeStamp>
              </AuditRecord>
        </Vendor:DataQuery>
    </FormData>

In this code fragment, the Vendor:DataQuery syntax specifies a new element with several new attributes and references to other existing (supported) elements. Note the additional Vendor:Revised attribute for FormData.

The SAS Clinical Standards Toolkit provides a macro to parse the ODM XML file to identify currently unsupported elements and tags. This macro, %CSTUTIL_READXMLTAGS, is located in the primary SAS Clinical Standards Toolkit autocall library (!sasroot/cstframework/sasmacro).

Here is an example of a call to the %CSTUTIL_READXMLTAGS macro:

%cstutil_readxmltags(
      _cstxmlfilename=inxml
     ,_cstxmlreporting=Dataset
     ,_cstxmlelementds=work.cstodmelements
     ,_cstxmlattrds=work.cstodmattributes);

In this call, the XML file to be parsed is specified with the inxml fileref. The results of parsing are to be written to two data sets: work.cstodmelements for all unique elements found in the XML file and work.cstodmattributes for all unique attributes found that are associated with each unique element.