Abstract
This paper presents an ontologically founded basic architecture for information systems, which are intended to capture, represent, and maintain metadata for various domains of clinical and epidemiological research. Clinical trials exhibit an important basis for clinical research, and the accurate specification of metadata and their documentation and application in clinical and epidemiological study projects represents a significant expense in the project preparation and has a relevant impact on the value and quality of these studies.An ontological foundation of an information system provides a semantic framework for the precise specification of those entities which are presented in this system. This semantic framework should be grounded, according to our approach, on a suitable top-level ontology. Such an ontological foundation leads to a deeper understanding of the entities of the domain under consideration, and provides a common unifying semantic basis, which supports the integration of data and the interoperability between different information systems.The intended information systems will be applied to the field of clinical and epidemiological research and will provide, depending on the application context, a variety of functionalities. In the present paper, we focus on a basic architecture which might be common to all such information systems. The research, set forth in this paper, is included in a broader framework of clinical research and continues the work of the IMISE on these topics.
Highlights
Clinical trials exhibit an important basis for clinical research
Basics of GFO GFO (General Formal Ontology) is a top-level ontology being developed at the IMISE, university of Leipzig [14], [15]
Concrete individuals are in space and time, whereas abstract individuals are independent of space and time
Summary
Clinical trials exhibit an important basis for clinical research. A clinical trial can be understood as a planned experiment which includes patients and is designed to gain insights into the etiology and progression of diseases, as well as to analyze new diagnostic and treatment procedures and, in particular, to test new drugs, [1], [2], [3].Clinical and epidemiological studies can be divided into three stages, the stage of planning and design, the execution of the study, and, the interpretation of the resulting data. The planning and preparation of Case Report Forms (CRFs) of a study is carried out by data managers in collaboration with project managers, biometricians and computer scientists. A CRF describes a data entry form of a clinical trial, for instance, questionnaire, interview, laboratory or research protocol. Concrete individuals are further classified with respect to the type of relation, which they have to space and time. They are categorized into continuants, presentials and processes. Another classification principle for concrete individuals, to be discussed pertains to the distinction between attributives and bearers
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