Enhancing Flexibility in Clinical Trials using Workflow Management Systems

Abstract

In the medical environment, clinical research has been predominantly paper-based. The Case Report Form (CRF) is an example of paper-based tools used in documenting clinical trials. A clinical trial can be understood to be a business process. This also means that automating the clinical trial can be referred to as a workflow process. In this research, we seek to automate the clinical trial in order to support the medical practitioners to ably translate their natural language format including CRFs using a workflow system. However we also address the need for flexibility in workflow models in the clinical trials that operate under specific guidelines in form of protocols. To attain the required level of flexibility in clinical trial workflow models, we use the constraint-based modeling language. The results from the validation indicate that the designed workflow modeling framework meets the required level of flexibility with respect to its usefulness and usability.