Study/Trial Design Model-XML
Study/Trial Design Model in XML (SDM-XML) is an extension of ODM-XML and allows organizations to provide rigorous, machine-readable, interchangeable descriptions of the designs of their clinical studies, including treatment plans, eligibility and times and events. 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.
Study Design in XML Version 1.0
The specification document is available for download as a PDF file. A ZIP file containing the XML schemas, examples, and an SDM-XML element and attribute reference is also available.