x4T-EDC: A Prototype for Study Documentation Based on the Single Source Concept

Bruland Philipp, Forster Christian, Dugas Martin

Abstract

Data collection is essential in clinical studies. The single source approach aims to integrate Electronic Health Records (EHR) and Electronic Data Capture (EDC) systems. Due to the lack of EDC system with single source functionality, we intended to enhance our single source system x4T to a small-scale EDC system. x4T uses CDISC ODM as format for study documentation forms. Functional and non-functional requirements regarding EDC were identified through focus groups with IT and medical experts. User management and audit trail were identified as important EDC-features. To re-use data values of the EHR, study items have to be semantically matched. We have enhanced our x4T-system towards a small-scale EDC system.