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Christiansen D, Kubick W. The CDISC metadata model; November 26, 2001.


The CDISC Submission Data Standards Metadata Approach


The CDISC Submission Data Model has focused on the use of effective metadata as the most practical way of establishing meaningful standards applicable to electronic data submitted for FDA review. Metadata is defined as “data about the data”; in other words, metadata includes description of the content, context, structure, and/or purpose of a database. It is important to recognize that the metadata provided by the model is intended to be the minimum required to meet the need of FDA users, and is not intended to fully meet all of the needs of the sponsor’s data management, statistics, or other internal groups. Additional internal metadata standards will be desirable within most organizations to govern the ways that data is captured, cleaned, and analyzed statistically. Available through the following link, click here.

Electronic Medical Records: "What the Patient Should Order"

Open global standards, workflow integration profiles, and related processes have been developed through consensus-based procedures. Although these standards and profiles should be augmented with additional therapeutic area–based content standards, they are available now to enable the use of electronic health records to directly support clinical research concurrent with patient care...


Publication: Science Translational Medicine, pp. 24-28, Vol. 1, Nos. 1-4, October (2009)


CDISC is moving forward on a project called SHARE.  This article describes why we feel that the time is right for this project (which has long been of interest in CDISC), why CDISC is poised to lead SHARE and why SHARE will increase the value of an investment in adopting the global CDISC standards for medical research ...


Publication: CDISC Newsletter

ANSI Workgroup Formed to Prioritize Healthcare IT Needs to Support Clinical Research

Washington, DC, November 19, 2008:   The American National Standards Institute (ANSI), coordinator of the U.S. standards and conformity assessment system, has formed a new public and private-sector working group to promote convergence within the global clinical research and healthcare arenas.