Fischer Anja S, Mansmann Ulrich
Institute for Medical Informatics, Biometry and Epidemiology (IBE), Ludwig-Maximilians-University Munich, Germany.
Stud Health Technol Inform. 2011;169:857-61.
In many medical indications clinical research is organized within study groups which provide and maintain the clinical infrastructure for their randomized clinical trials. Each group also manages a data center where high quality databases store the study specific individual patient data. Sharing this data between study groups is not straightforward. Therefore, a concept is needed which allows to represent a detailed overview on the information available across the cooperating groups. We propose a metadata based patient register and describe a first prototype. It provides information about available patient data sets to interested research partners while the typical register approach only collects a predefined limited core data set. This register implementation enables cooperative groups to allocate clinical data for future research projects in distributed data sources beyond the restrictions of core data sets. Additionally, it supports the research network in communication and data standardization and complies with a governance structure which is compatible with ethical aspects, privacy protection, and patient rights.
在许多医学适应症中，临床研究是在研究组内组织进行的，这些研究组为其随机临床试验提供并维持临床基础设施。每个研究组还管理一个数据中心，高质量的数据库在其中存储特定研究的个体患者数据。在研究组之间共享这些数据并非易事。因此，需要一个概念来呈现合作组之间可用信息的详细概述。我们提出了一种基于元数据的患者登记册并描述了第一个原型。它向感兴趣的研究伙伴提供有关可用患者数据集的信息，而典型的登记册方法仅收集预定义的有限核心数据集。这种登记册的实现使合作组能够在核心数据集的限制之外，为分布式数据源中的未来研究项目分配临床数据。此外，它支持研究网络进行通信和数据标准化，并符合与伦理方面、隐私保护和患者权利兼容的治理结构。
