Stausberg Jürgen, Löbe Matthias, Verplancke Philippe, Drepper Johannes, Herre Heinrich, Löffler Markus
IBE, Medical Faculty, Ludwig-Maximilians-Universität München, D-81377 München, Germany.
Stud Health Technol Inform. 2009;150:409-13.
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 für 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.
在临床试验或注册数据库中，病例报告表（CRF）的规划大多是一个从零开始的非正式过程，涉及领域专家、生物统计学家和文档专家。德国医学研究网络的伞式组织Telematikplattform für Medizinische Forschungsnetze旨在通过一个元数据存储库来支持和改进这一过程，该存储库涵盖注册数据库和试验数据库中使用的变量和值列表。元数据存储库的用例范围从病例报告表的规范到通过正式审查对变量集合、变量和值列表进行协调。用于存储元数据的仓库至少应符合ISO/IEC 11179信息技术——元数据注册库第3部分“注册库元模型和基本属性”的定义。元数据存储库的实现应提供符合临床数据交换标准协会操作数据模型标准的元数据导入和导出功能。它将促进病例报告表和数据模型的创建，提高病例报告表和数据模型的质量，支持变量和值列表的协调，并支持元数据与数据的映射。
