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 um brella organization for medical research in Germany, ai ms 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 form al 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.

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Foundations of a metadata repository for databases of registers and trials.

The importance of Medical Data Dictionaries in information and knowledge processing in medicine increased in the last years. To reach a practicable use in Health Care Information Systems, the availability of a Medical Data Dictionary in a Relational Database Management System (RDBMS) is necessary, providing a standardized access with the Structured Query Language. The objective of our project was the migration of a previously developed vocabulary to a RDBMS. Our Entity-Relationship-Model contains 4 entities: term, link, maintenance and library. Each element of the medical terminology has to be defined as a term. A link connects two terms or one existing link and a term through a link type. That link type itself is defined as a term. The Medical Data Dictionary was successfully implemented with ORACLE7. The database model is flexible enough to store existing taxonomic vocabularies and to support concept representation languages.

Realization of a Medical Data Dictionary in a Relational Database Management System

The development of open and integrated knowledge bases makes new demands on the definition of the used terminology. The definition should be realized in a data dictionary separated from the knowledge base. Within the works done at a reference model of medical knowledge, a data dictionary has been developed and used in different applications: a term definition shell, a documentation tool and a knowledge base. The data dictionary includes that part of terminology, which is largely independent of a certain knowledge model. For that reason, the data dictionary can be used as a basis for integrating knowledge bases into information systems, for knowledge sharing and reuse and for modular development of knowledge-based systems.

J Stausberg

Papers

Terminological reference of a knowledge-based system: the data dictionary.