Today marks another major milestone toward the realization of an interoperable eTMF standard for the BioPharma industry. The OASIS eTMF Standard Technical Committee today voted on and adopted the TC’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) was designed to support a broad range of metadata and terms, including terms from the Trial Master File Reference Model.
Designed to support existing industry standards initiatives from CDISC, HL7, PhUSE and FDA that utilize the growing industry movement toward use of W3C semantic web standards and a standards-based controlled vocabulary, the OASIS eTMF CCS 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, or 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 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 consistent 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 Technical Committee, or join the discussion on the eTMF Standard TC’s LinkedIn group: Search on OASIS eTMF Standard.