Another major milestone toward the realization of an interoperable eTMF standard for the BioPharma industry has been achieved. On February 17, the OASIS eTMF Standard Technical Committee voted on and adopted the technical committee’s Content Classification System to enable consistent classification, naming, representation and exchange of eTMF content between eTMF applications as well as other clinical trial applications. The Content Classification System (CCS) is part of the back-end architecture of the Oasis eTMF Standard and is designed to support a broad range of metadata and terms, including terms from the Trial Master File Reference Model.
The OASIS eTMF CCS is designed to support existing industry standards initiatives from CDISC, HL7, PhUSE and FDA that utilize the growing industry use of W3C semantic web standards and a standards-based controlled vocabulary. It is a significant step toward an interoperable eTMF standard that will enable collaboration between sponsors, CROs, research organizations, regulators and other stakeholders online, offline or through secure cloud applications.
Enhanced eTMF Content Interoperability—the ability to share information between applications or systems—will help organizations to share eTMF content between eTMF applications from disparate vendors, as well as between eTMF applications and other clinical trial systems such as clinical trial management systems (CTMS). By enhancing interoperability, burdensome systems integration tasks between clinical trial systems and eTMF systems will be simplified, accelerating information sharing.
On the technical front, the Content Classification System layer is based on industry standards and is comprised of three primary components, including a content classification component, a core metadata component, and a content model component. The content classification component consists of a policy-based set of rules to classify, name and number clinical trial master file content. The metadata component defines a core set of metadata that supports consisting tagging of content and uses a flexible rules based-metadata policies that uses controlled vocabulary terms sourced primarily from W3C, NCI Thesaurus, CDISC, BRIDG and HL7. The content model component uses industry standard W3C semantic web OWL and RDF/XML to model and exchange content classification ontologies.
The adoption of the OASIS eTMF Content Classification layer is a definitive step on the road to a new global eTMF Standard that will drive new efficiencies in clinical trial operations and data exchange. Special recognition goes to the organizations involved in moving the initiative forward. Take a few minutes to learn more about the OASIS eTMF Standard TC, or join the discussion on the eTMF Standard TC’s Linked In group.