XML LIBNAME engine

Operational Data Model (ODM). The ODM is a powerful XML-based data model that allows for XMF-based transmission of any data involved in the conduct of clinical trials. SAS has provided support for importing and exporting ODM files via the CDISC procedure and the XML LIBNAME engine. 

Beginning with SAS 8, there are tools in SAS to help you read and write XML files. Starting with SAS 9.1, SAS provides XML import support via the XML LIBNAME engine (previously called SXLE) and the SAS XML mapper (previously called Atlas). 

Here is an example of an XML map file that will help the XML LIBNAME engine to read the lab normal XML data. 

Program 3.11 Using the XML LIBNAME Engine to Read XML Data... 

Notice how the XML engine is indicated in PROC CONTENTS and that the number of observations is set to missing. For further guidance refer to SAS Help and Documentation, where the XML LIBNAME engine is documented extensively. 

With the advent of the CDISC ODM model and the progression of the FDA s endorsement of the CDISC models, I believe that eventually all clinical trial data will likely be submitted to the FDA in ODM or a similar XML format. The XML-based ODM is already gaining acceptance within the pharmaceutical industry as a means of transferring clinical trial data. SAS provides two ways to produce ODM data files using either PROC CDISC or the XML LIBNAME engine. 

The other option for producing ODM XML is to use the XML LIBNAME engine. You can convert the previous DM SAS data set to ODM version 1.2 by running the following SAS program. 

The resulting ODM XML file produced by the XML LIBNAME engine is very similar to the one produced by PROC CDISC. However, PROC CDISC allows you to specify and pass more of the metadata information along to the XML file. If you need to create customized XML files for a sponsor that do not match the ODM specification, you can use the SAS XML Mapper and the XML LIBNAME engine to write your own custom XML files. 

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