Study/Trial Design Model

Study Design in XML Version 1.0

The CDISC Study Design Model in XML (SDM-XML) standard, version 1.0, has been released.  The specification document is available for download as a PDF file.  A ZIP file containing the XML Schemas, several examples, and an SDM-XML element and attribute reference also is available.

SDM-XML allows organizations to provide rigorous, machine-readable, interchangeable descriptions of the designs of their clinical studies. As an extension to the existing CDISC Operational Data Model (ODM) specification, SDM-XML affords implementers the ease of leveraging existing ODM concepts and re-using existing ODM definitions. SDM-XML defines three key sub-modules – Structure, Workflow, and Timing – permitting various levels of detail in any representation of a clinical study’s design, while allowing a high degree of authoring flexibility.

SDM-XML Version 1.0

Supporting Schemas, Examples, and References