Business rules in clinical trials

Abstract

The paper focuses on the scope of the clinical trials. As clinical trials are rigorously controlled, it is important to have a well-designed control mechanism for clinical trials quality assurance. Each clinical trial is executed according to a set of rules. All the rules for a particular clinical trial are described in different source documents and are not stated explicitly. While rules for particular trial are not organized as a whole, it complicates the control of the trial. The need for accurate recording and processing of patient data is fundamental to any clinical trial. If data stored in the clinical trial database are incorrect, conclusions of the analyses will also inevitably be incorrect. The need of a central storage for rules in particular trial is obvious. The clinical trial business rules repository may be used to reuse the knowledge gathered in one clinical for further trials. The paper presents a method for business rules retrieval from UML models and the employment of proposed in conduct of clinical trials. The analysis of business rules approach principles application in clinical trials is presented.