title: Requirements on Clinical Trial Management Systems for Academic Site Management Organizations.
abstract: As a part of the introduction of a Clinical Trial Management System (CTMS) for an Academic Site Management Organization (SMO) we had to determine the requirements such a system has to meet. By performing extensive Requirements Engineering, we aimed at raising the success of the future system and the user satisfaction. Investigations revealed the existence of TORE (Task and Object-oriented Requirements Engineering), a task-driven approach for determining requirements on user interface- and information-intensive systems. In this paper, we present an adoption of this method for our purposes, resulting in a reasonable list of requirements for CTMS acquisition.
authors: Institute for Medical Informatics, Statistics and Epidemiology, Leipzig University.
authors: Martin
authors: M
authors: Schöbel
authors: Institute for Medical Informatics, Statistics and Epidemiology, Leipzig University.
authors: Sebastian
authors: S
authors: Stäubert
authors: Institute for Medical Informatics, Statistics and Epidemiology, Leipzig University.
authors: Matthias
authors: M
authors: Löbe
authors: Center for Clinical Trials Leipzig (ZKSL), Leipzig University.
authors: Kirsti
authors: K
authors: Meinel
authors: Institute for Medical Informatics, Statistics and Epidemiology, Leipzig University.
authors: Alfred
authors: A
authors: Winter
mesh_terms: D002986:Clinical Trials as Topic / Q000458:organization & administration*; D005858:Germany; D007256:Information Systems / Q000592:standards*; D014495:Universities