Compliance oriented process management using the example of clinical trials

Abstract

Compliance management is a key factor for clinical trials. This paper overviews the current situation of compliance management in clinical trials. The shortcomings of the as-is situation are analyzed as well as the current scientific approaches. To overcome the deficiencies, a framework for process oriented compliance management is presented. The extraction and modeling of compliance requirements in a process oriented way is explained. In addition a matching operator is presented, showing how different compliance standards can be made comparable. © 2012 Springer-Verlag.