ODM XML files

Program 8.3 Using PROC CDISC to Create an ODM XML File... 

Complete SAS documentation for PROC CDISC can be found at http //support.sas.com/md/base/topics/sxle82/TW8774.pdf. In the future, it is expected that PROC CDISC will be able to export multiple SAS data sets to a single ODM XML file. As the CDISC models and PROC CDISC rapidly evolve, continue to watch PROC CDISC as a tool for CDISC model conversion. 

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. 

PROC CDISC is a new SAS procedure that is available as a hotfix for SAS 8.2 and ships as part of SAS 9.1.3. PROC CDISC is a procedure that allows you to import (and export) XML files that are compliant with the CDISC ODM version 1.2 schema. Here is a two-observation sample demographics ODM file that you might want to import into SAS ... 

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. 

Clinical trial data that is not sent to the FDA can be exported from SAS in many ways other than SAS XPORT format files or ODM XML. This section discusses the numerous ways to export data from SAS to entities other than the FDA. 

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. 

Case Report Tabulation Data Definition Specification (Define.xml). Define.xml is the upcoming replacement for the data definition file (define.pdf) sent to the FDA with electronic submissions. Define.xml is based on the CDISC ODM model and is intended to provide a machine-readable version of define.pdf. Because define.xml is machine readable, the metadata about the submission data sets can be easily read by computer applications. This allows the FDA to work more easily with the data submitted to it. 

You need to define the key set variables for PROC CDISC to export your data to XML. ODM specifications have a maximum length of 100 characters for these fields, so here I have set the length of the key set fields to 100. It is important to understand what these key set fields are in order to set them properly. In brief, a STUDYEVENT is essentially a visit, and many FORMs can be attributed to a STUDYEVENT. A FORM is equivalent to a CRF page. An ITEMGROUP is a group of variables that make up a discrete piece or all of a FORM. The REPEATKEY fields indicate whether there are multiple observations within a STUDYEVENT, FORM, or ITEMGROUP. For the DM file all of the... 

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