Dziuballe Philipp, Forster Christian, Breil Bernhard, Thiemann Volker, Fritz Fleur, Lechtenbörger Jens, Vossen Gottfried, Dugas Martin
Department of Medical Informatics, University of Münster, Germany.
Stud Health Technol Inform. 2011;169:902-6.
Clinical trials often require large and redundant documentation efforts, because information systems in patient care and research are separated. In two clinical trials we have assessed the number of study items available in the clinical information system for re-use in clinical research. We have analysed common standards such as HL7, IHE RFD and CDISC ODM, regulatory constraints and the documentation process. Based on this analysis we have designed and implemented an architecture for an integrated clinical trial documentation workflow. Key aspects are the re-use of existing medical routine data and the integration into current documentation workflows.
临床试验通常需要大量且重复的文档工作，因为患者护理和研究中的信息系统是分开的。在两项临床试验中，我们评估了临床信息系统中可用于临床研究重复使用的研究项目数量。我们分析了诸如HL7、IHE RFD和CDISC ODM等通用标准、监管限制以及文档流程。基于此分析，我们设计并实施了一种用于综合临床试验文档工作流程的架构。关键方面是现有医疗常规数据的重复使用以及与当前文档工作流程的整合。
