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Study/Trial Design Model

The CDISC Study Design Model in XML (SDM-XML) allows organizations to provide rigorous, machine-readable, interchangeable descriptions of the designs of their clinical studies, including treatment plans, eligibility and times and events. 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.

Study Design in XML Version 1.0

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January 1, 2011

The CDISC Study Design Model in XML (SDM-XML) version 1.0 allows organizations to provide rigorous, machine-readable, interchangeable descriptions of the designs of their clinical studies, including treatment plans, eligibility and times and events. 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.

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.