Research Article

Translational Medicine and Patient Safety in Europe: TRANSFoRm—Architecture for the Learning Health System in Europe

Table 1

A table of outputs and exploitation plans.

TRANSFoRm outputExploitation plan

(1) Privacy model: a “zone” model with an explicit method of graphically depicting the zones and operation of filters between zonesPublished method [15]

(2) Provenance infrastructure: based on the Open Provenance Model REF, each infrastructure component captures a provenance trace that enables reconstruction of an audit trail for any given data elementPublished method [16]

(3) Clinical prediction rule ontology based web serviceThe diagnostic ontology has been made available as a public download in OWL format on the TRANSFoRm website (http://www.transformproject.eu/). A future project is required to extend the data beyond the three initial reasons for encounter

(4) Research data modelCDIM [12] and CRIM [13] have been published. A full description of the use of CDIM and CRIM in the construction of data node connectors will be published and made available on the TRANSFoRm website

(5) eCRFExtension of CDISC ODM and SDM by the incorporation of archetypes with references to the CRIM and CDIM models will be published and discussions are ongoing with CDISC regarding future incorporation into the standards. A reference implementation of the clinical trial system will be maintained within the European Institute. At present, individual archetypes have to be written by hand; discussions are in hand for the production of an archetype authoring tool

(6) Data federationA reference implementation of the genotype-phenotype study system will be maintained within the European Institute. Search authoring tools will be available open source

(7) DSS integrationThe DSS is currently integrated with the InPS Vision 3 system. Further work is required to move this to a data node connector/CDIM-based flexible system