CDISC has recently released the "Study Design Model" (SDM) for public review. You can find the draft specification, XML-schemas and a set of samples (e.g. for the workflow of the LZZT trial) at: http://www.cdisc.org/study-trial-design. The SDM is an extension of the ODM standard, the well known CDISC standard for exchange of study design (metadata) and of clinical data . It adds a number of features to the ODM that many of us have long been waiting for, such as trial parameters, inclusion/exclusion criteria, study structure (arms, epochs, segments, activities) and especially, workflows and timing. Please review this new draft standard and send your comments to CDISC before July 22nd.
At the same time, I can announce a new version of the "ODM Study Designer" which already implements the new SDM standad. You can find all necessary information at http://www.xml4pharma.com/CDISC_Products/ODMDesigner.html.
I will however tell something more about how the new SDM standard has been implemented in the ODM Study Designer in a next post.
