Smith Corey B, Kim George, Assar Karen, Barned Susan, Rothschild Adam, Miller Robert E
School of Medicine, The Johns Hopkins University, Baltimore, MD, USA.
AMIA Annu Symp Proc. 2003;2003:1010.
We present a framework for understanding and developing an Information Technology (IT) infrastructure for human subject research. First, we review the process of clinical research in an academic medical center. Next,we describe the entities,roles,and functional relationships within the clinical research enterprise to define a conceptual data model. Finally, we address design and implementation issues for an IT infrastructure that can be adapted to the local needs of research institutions.
我们提出了一个用于理解和开发人类受试者研究信息技术（IT）基础设施的框架。首先，我们回顾学术医疗中心的临床研究过程。接下来，我们描述临床研究企业中的实体、角色和功能关系，以定义一个概念数据模型。最后，我们讨论可适用于研究机构当地需求的IT基础设施的设计和实施问题。
