Fridsma Douglas B, Evans Julie, Hastak Smita, Mead Charles N
Department of Biomedical Informatics, Arizona State University, Phoenix, AZ 85004-2157, USA.
J Am Med Inform Assoc. 2008 Mar-Apr;15(2):130-7. doi: 10.1197/jamia.M2556. Epub 2007 Dec 20.
The Biomedical Research Integrated Domain Group (BRIDG) project is a collaborative initiative between the National Cancer Institute (NCI), the Clinical Data Interchange Standards Consortium (CDISC), the Regulated Clinical Research Information Management Technical Committee (RCRIM TC) of Health Level 7 (HL7), and the Food and Drug Administration (FDA) to develop a model of the shared understanding of the semantics of clinical research.
The BRIDG project is based on open-source collaborative principles and an implementation-independent, use-case driven approach to model development. In the BRIDG model, declarative and procedural knowledge are represented using the Unified Modeling Language (UML) class, activity and state diagrams.
The BRIDG model currently contains harmonized semantics from four project use cases: the caXchange project and the patient study calendar project from caBIG; the standard data tabular model (SDTM) from CDISC; and the regulated products submission model (RPS) from HL7. Scalable harmonization processes have been developed to expand the model with content from additional use cases.
The first official release of the BRIDG model was published in June 2007. Use of the BRIDG model by the NCI has supported the rapid development of semantic interoperability across applications within the caBIG program.
The BRIDG project has brought together different standards communities to clarify the semantics of clinical research across pharmaceutical, regulatory, and research organizations. Currently, the NCI uses the BRIDG model to support interoperable application development in the caBIG, and CDISC and HL7 are using the BRIDG model to support standards development.
生物医学研究集成领域组（BRIDG）项目是美国国立癌症研究所（NCI）、临床数据交换标准协会（CDISC）、健康级别7（HL7）的规范临床研究信息管理技术委员会（RCRIM TC）以及美国食品药品监督管理局（FDA）之间的一项合作计划，旨在开发一个对临床研究语义达成共享理解的模型。
BRIDG项目基于开源协作原则以及一种与实现无关、用例驱动的模型开发方法。在BRIDG模型中，声明性和过程性知识使用统一建模语言（UML）类图、活动图和状态图来表示。
BRIDG模型目前包含来自四个项目用例的统一语义：caBIG的caXchange项目和患者研究日历项目；CDISC的标准数据表模型（SDTM）；以及HL7的规范产品提交模型（RPS）。已经开发出可扩展的统一过程，以便用来自其他用例的内容扩展该模型。
BRIDG模型的首个官方版本于2007年6月发布。NCI对BRIDG模型的使用支持了caBIG计划内各应用之间语义互操作性的快速发展。
BRIDG项目汇聚了不同的标准团体，以阐明制药、监管和研究组织之间临床研究的语义。目前，NCI使用BRIDG模型来支持caBIG中的可互操作应用开发，而CDISC和HL7则使用BRIDG模型来支持标准制定。
