Towards a common framework for clinical trials information systems.

This work describes the strategies for data modeling and implementation and the general architecture of COATI, a Clinical Trials information system that has been in production for more than three years. We discuss how the ICH guidelines influenced the system design, how we used conventional relational and EAV tables and how we integrated third-party software packages into our system. We describe a new architecture that forms the basis of a common framework for Clinical Trials information systems. This structure is based on the concept of a Common Information Framework (CIF). We have defined standard objects and corresponding methods for the CIF as an essential step towards the development of Clinical Trials Informatics.