Angelow Aniela, Schmidt Matthias, Weitmann Kerstin, Schwedler Susanne, Vogt Hannes, Havemann Christoph, Hoffmann Wolfgang
Institute for Community Medicine, Department of Epidemiology of Health Care and Community Health, Ellernholzstr. 1-2, 17487 Greifswald, Germany.
Comput Methods Programs Biomed. 2008 Jul;91(1):82-90. doi: 10.1016/j.cmpb.2008.02.002. Epub 2008 Apr 10.
In our report we describe concept, strategies and implementation of a central biosample and data management (CSDM) system in the three-centre clinical study of the Transregional Collaborative Research Centre "Inflammatory Cardiomyopathy - Molecular Pathogenesis and Therapy" SFB/TR 19, Germany. Following the requirements of high system resource availability, data security, privacy protection and quality assurance, a web-based CSDM was developed based on Java 2 Enterprise Edition using an Oracle database. An efficient and reliable sample documentation system using bar code labelling, a partitioning storage algorithm and an online documentation software was implemented. An online electronic case report form is used to acquire patient-related data. Strict rules for access to the online applications and secure connections are used to account for privacy protection and data security. Challenges for the implementation of the CSDM resided at project, technical and organisational level as well as at staff level.
在我们的报告中，我们描述了德国跨地区合作研究中心SFB/TR 19“炎症性心肌病——分子发病机制与治疗”的三中心临床研究中，中央生物样本和数据管理（CSDM）系统的概念、策略及实施情况。遵循高系统资源可用性、数据安全、隐私保护和质量保证的要求，基于Java 2企业版并使用Oracle数据库开发了一个基于网络的CSDM。实施了一个高效可靠的样本记录系统，该系统采用条形码标签、分区存储算法和在线记录软件。使用在线电子病例报告表来获取患者相关数据。对在线应用程序的访问和安全连接采用了严格规则，以实现隐私保护和数据安全。CSDM实施过程中的挑战存在于项目、技术、组织层面以及员工层面。
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