title: Managing complex change in clinical study metadata.
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.
authors.affiliation: Center for Medical Informatics, Yale School of Medicine, New Haven, CT 06520-8009, USA. cynthia.brandt@yale.edu
authors.forename: Cynthia A
authors.initials: CA
authors.lastname: Brandt
authors.forename: Rohit
authors.initials: R
authors.lastname: Gadagkar
authors.forename: Cesar
authors.initials: C
authors.lastname: Rodriguez
authors.forename: Prakash M
authors.initials: PM
authors.lastname: Nadkarni
mesh_terms: D001185:Artificial Intelligence; D003199:Computer Systems; D003628:Database Management Systems; D020000:Decision Support Systems, Clinical; D010865:Pilot Projects; D012984:Software; D018875:Vocabulary, Controlled