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First published June 7, 2004 as JAMIA PrePrint; doi:10.1197/jamia.M1511
Journal of the American Medical Informatics Association 2004;11(5):380-391
© 2004 American Medical Informatics Association

A more recent version of this article appeared on September 1, 2004
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Submitted on December 9, 2003
Accepted on March 24, 2004

Managing Complex Change in Clinical Study Metadata

Cynthia A. Brandt MD, MPH1*, Rohit Gadagkar MS1, Cesar Rodriguez MD1, and Prakash M. Nadkarni MD1

Affiliation of the authors: 1 Center for Medical Informatics, Yale School of Medicine, New Haven, CT

* To whom correspondence should be addressed.

In highly functional metadata-driven software, the inter-relationships within the metadata become complex, and maintenance becomes challenging. We describe an approach to metadata management that uses a knowledge-base subschema to store centralized information about metadata dependencies and use cases involving specific types of metadata modification. Our system borrows ideas from production-rule systems in that some of this information is a high-level specification that is interpreted and executed dynamically by a middleware engine. Our approach is implemented in TrialDB, a generic clinical study data management system. We review approaches that have been used for metadata management in other contexts, and describe the features, capabilities and limitations of our system.




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