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J Am Med Inform Assoc 2004;11:380-391 doi:10.1197/jamia.M1511
  • The Practice of Informatics
  • Application of Information Technology

Managing Complex Change in Clinical Study Metadata

  1. Cynthia A Brandt,
  2. Rohit Gadagkar,
  3. Cesar Rodriguez,
  4. Prakash M Nadkarni
  1. Affiliation of the authors: Center for Medical Informatics, Yale School of Medicine, New Haven, CT
  1. Correspondence and reprints: Cynthia A. Brandt, MD, MPH, Center for Medical Informatics, Yale School of Medicine, New Haven, CT 06520-8009; e-mail: <cynthia.brandt{at}yale.edu>
  • Received 9 December 2003
  • Accepted 24 March 2004

Abstract

In highly functional metadata-driven software, the interrelationships 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.

Footnotes

  • Supported by grants NIH K23 RR16042, M01 RR06022, P20 LM07253, U01 CA78266, and ES 10867.

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