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Clinical research and routine care documentation have traditionally been performed in a dual-source approach, where data is collected redundantly and maintained in separated systems.  The generic x4T single-source process removes redundant steps and is adoptable to specific types of studies. In support of the various processes, we have designed and implemented an architecture called x4T based on CDISC ODM.  The software has been deployed in three different use cases containing up to 3976 subjects until now and allows real-time access to live data from routine care documentation systems.

Connecting clinical care and research: Single-source with x4T – Process design, architecture, and use cases