title: Comprehensive functional specifications and design for IT support of clinical research at an academic medical center.
abstract: 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.
authors.affiliation: School of Medicine, The Johns Hopkins University, Baltimore, MD, USA.
authors.forename: Corey B
authors.initials: CB
authors.lastname: Smith
authors.forename: George
authors.initials: G
authors.lastname: Kim
authors.forename: Karen
authors.initials: K
authors.lastname: Assar
authors.forename: Susan
authors.initials: S
authors.lastname: Barned
authors.forename: Adam
authors.initials: A
authors.lastname: Rothschild
authors.forename: Robert E
authors.initials: RE
authors.lastname: Miller
mesh_terms: D000046:Academic Medical Centers; D035843:Biomedical Research; D006801:Humans; D007256:Information Systems; D018511:Systems Integration