Background: Electronic case report forms (eCRF) play a key role in medical studies and medical data registries (MDR) for clinical research. The creation of suitable eCRFs is a challenging and yet a very individual task. Objectives: We plan to create evidence-based templates for eCRFs which are aligned with existing studies or MDRs. Methods: In this paper we investigated existing standards for eCRFs, defined uses cases and derived requirements needed to identify and annotate data items and pertinent information within study protocols, literature or patient cases. Results: In order to establish evidence-based eCRF templates based on annotated text documents, a standard-based, hierarchical structure with linkage to existing data repositories needs to be modeled. Standards like ISO/IEC 11179 provide a necessary base, which needs to be extended with proper linking functions. Conclusion: Linking evidence-based sources with eCRFs allows creating templates, which could be used to define eCRFs for new clinical studies or even compare studies among them. As a next step, the derived requirements from this paper will be used to establish an ontology-based structure for annotating existing text-documents with eCRF data elements.
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机译：背景：电子案例报告表格（ECRF）在医学研究和医疗数据注册表（MDR）中发挥关键作用进行临床研究。合适的ECRF的创建是一个具有挑战性的，但却是一个非常个性的任务。目标：我们计划为ECRF创建基于证据的模板，该模板与现有的研究或MDR对齐。方法：在本文中，我们调查了ECRF的现有标准，定义了使用案例和派生要求，以在研究协议，文献或患者案例中识别和注释数据项和相关信息。结果：为了基于注释的文本文档建立基于证据的ECRF模板，需要建模一个基于标准的基于数据存储库的分层结构。 ISO / IEC 11179的标准提供了必要的基础，需要使用适当的链接功能扩展。结论：将基于证据的源与ECRF联系起来允许创建模板，该模板可用于定义新的临床研究的ECRF甚至比较他们的研究。作为下一步，本文的派生要求将用于建立基于本体的结构，用于使用ECRF数据元素注释现有文本文档。
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