Comprehensive functional specifications and design for IT support of clinical research at an academic medical center.

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.