Paper Info
Title
Foundations of a metadata repository for databases of registers and trials.
Abstract
The planning of case report forms (CRFs) in clinical trials or databases in registers is mostly an informal process starting from scratch involving domain experts, biometricians, and documentation specialists. The Telematikplattform fur Medizinische Forschungsnetze, an umbrella organization for medical research in Germany, aims at supporting and improving this process with a metadata repository, covering the variables and value lists used in databases of registers and trials. The use cases for the metadata repository range from a specification of case report forms to the harmonization of variable collections, variables, and value lists through a formal review. The warehouse used for the storage of the metadata should at least fulfill the definition of part 3 "Registry metamodel and basic attributes" of ISO/IEC 11179 Information technology - Metadata registries. An implementation of the metadata repository should offer an import and export of metadata in the Operational Data Model standard of the Clinical Data Interchange Standards Consortium. It will facilitate the creation of CRFs and data models, improve the quality of CRFs and data models, support the harmonization of variables and value lists, and support the mapping of metadata and data.
Year
DOI
Venue
2009
10.3233/978-1-60750-044-5-409
Studies in Health Technology and Informatics
Keywords
Field
DocType
clinical trials,documentation standards,metadata,registries
Metadata repository,Metadata,Data mining,Meta Data Services,Data element,Computer science,Data mapping,Data dictionary,Documentation,Metamodeling,Database
Conference
Volume
ISSN
Citations 
150
0926-9630
1
PageRank 
References 
Authors
0.55
4
6
Name
Order
Citations
PageRank
Jürgen Stausberg15114.15
Matthias Löbe2119.04
Philippe Verplancke310.55
Johannes Drepper422.08
Heinrich Herre552759.57
Markus Löffler6488.56