January 15, 2014
On Monday Jan 6 the OASIS eTMF Standard Technical Committee approved a three-tier technical architecture for the representation and exchange of electronic trial master file data. The technical architecture includes a Content Classification Layer, a Vocabulary Layer, and a Web Standard Technology Layer. Further, the team approved the use of RDF/XML to describe, share and exchange eTMF taxonomies for eTMF interoperability among systems. Why is this important? First, the three-tier architecture provides a standardized structure in which electronic clinical trial documents and content can be managed. It provides a framework for organizing trial master files according to classifications and their relationships as well as a framework for representing metadata, vocabulary and properties of the data. This type of framework is typically referred to as an ‘ontology’ and enables standards-based representation of clinical trial data online as well as offline. In terms of the interoperability standard for eTMF content model exchange, the team agreed that RDF/XML represents the industry benchmark for web standard-based ontology modeling and exchange methodologies. RDF/XML is widely adopted in the life sciences and healthcare industry as a format for representing ontologies and can be edited in free open source editors such as the popular Protégé editor. Organizations like Health Level Seven (HL7), NCI Thesaurus, and the new CDISC/FDA PhUSE project have adopted RDF/XML as a format to model and represent vocabularies as well as other clinical trial data. At the risk of being too technical in this forum, RDF/XML is a World Wide Web Consortium (W3C) technical syntax for the handling of machine readable content using ‘smart web’ technologies. For a variety of reasons, RDF/XML is viewed as one of the best technologies for machines to organize, discover and to even interpret data across domains through logical reasoning. It adds a new level of interoperability with other published vocabularies and ontologies as well as resource discovery that greatly surpasses plain XML. It is important to recognize that today’s approval only pertains to the framework regarding how eTMF content will be represented and organized. We still need to consider the content classification schema as well as other technical elements for representing data. These areas will be vetted in significantly more detail in future meetings of the Technical Committee. We are excited by the initiation of the OASIS eTMF Technical Committee and the progress that was achieved in our first working session. Gaining consensus on the technical architecture and web standards to be used for eTMF content model representation and exchange provides a framework in which to define the classification schema and hierarchy, metadata, content models, core vocabulary, digital signatures, and business process modeling standards in the pursuit of a universally accepted eTMF standard. More information on the OASIS eTMF Standard Technical Committee’s progress can be viewed at OASIS’ website. Interested in updates on the OASIS eTMF Standards Initiative? Join the LinkedIn discussion group by visiting LinkedIn and searching for OASIS eTMF Standard.