Brandt C A, Deshpande A M, Lu C, Ananth G, Sun K, Gadagkar R, Morse R, Rodriguez C, Miller P L, Nadkarni P M
Yale University School of Medicine, New Haven, CT, USA.
AMIA Annu Symp Proc. 2003;2003:794.
Clinical Study Data Management Systems (CSDMSs) are a class of software that support centralized management of data generated during the conduct of clinical studies. Commercial CSDMSs include Oracle Clinical, ClinTrial and MetaTrial. Such systems, which are typically deployed at an institutional or organizational level, must accommodate diverse types of data from different clinical domains that is generated by different groups of clinical investigators. Large-scale CSDMSs typically employ a high-end database engine that is usually accessed over an intranet or the Internet using Web-based technologies. CSDMSs in institution-wide use for a variety of clinical domains are best served by entity-attribute-value (EAV) modeling for the clinical data: all the commercial CSDMSs that we are aware of use EAV design. However, de novo development of EAV databases for data management is a challenging task. A large body of generic metadata-driven code must be developed before a basic EAV application can be written. Clearly, the availability of pre-existing software with the requisite functionality would be very valuable. We will discuss the benefits of such software being in open-source form.
临床研究数据管理系统(CSDMSs)是一类支持对临床研究过程中产生的数据进行集中管理的软件。商业CSDMSs包括Oracle Clinical、ClinTrial和MetaTrial。这类系统通常部署在机构或组织层面,必须能够处理来自不同临床领域、由不同临床研究人员群体产生的各种类型的数据。大规模的CSDMSs通常采用高端数据库引擎,通常通过基于Web的技术在内联网或互联网上进行访问。对于机构范围内用于各种临床领域的CSDMSs,临床数据采用实体-属性-值(EAV)建模最为合适:我们所知道的所有商业CSDMSs都采用EAV设计。然而,从头开发用于数据管理的EAV数据库是一项具有挑战性的任务。在编写基本的EAV应用程序之前,必须开发大量通用的元数据驱动代码。显然,具备所需功能的现有软件的可用性将非常有价值。我们将讨论此类软件采用开源形式的好处。