2014 07 22 13 30 Understanding the OASIS eTMF Specification for Technical Professionals

This webinar, presented by OASIS Open, provides an in-depth exploration of the recently released OASIS Electronic Trial Master File (eTMF) Specification Version 1.0, specifically tailored for technical professionals in the BioPharma industry. The speakers, Zach Schmidt and Rich Lustig, begin by establishing the critical need for standardized electronic systems in clinical trials as the industry rapidly moves away from paper-based processes. They highlight that the absence of such standards leads to significant challenges, including system silos, high maintenance costs, vendor lock-in, and hindered productivity, ultimately slowing down the delivery of new drugs to market. The core purpose of the OASIS eTMF standard is to address these issues by providing an open, interoperable framework for exchanging clinical trial information seamlessly and efficiently.

The presentation details the foundational principles and architectural components of the OASIS eTMF standard. It emphasizes the use of open web standards and a controlled vocabulary to ensure flexibility, interoperability, and compliance. The standard is built upon three key layers: a Classification System Layer that defines the eTMF content model, metadata, and rules; a Vocabulary Layer that incorporates metadata terms from established organizations like the National Cancer Institute (NCI), CDISC, and HL7; and a Web Technology Layer that provides core services for interoperability, digital signatures, and business process modeling. This multi-layered approach ensures that the standard can support various content models, including the widely used TMF Reference Model, through flexible mapping and display labels, while maintaining a consistent underlying data structure.

A significant portion of the webinar is dedicated to demonstrating the practical application of the standard. The speakers showcase the NCI Thesaurus as the global repository for the controlled vocabulary terms used in the eTMF specification, illustrating how each term has a unique code, definition, and URL, curated for health science metadata. They also introduce Protege, a free open-source taxonomy editing tool from Stanford University, demonstrating how it can be used to import and navigate the eTMF hierarchy, content types, and associated metadata (core, domain-specific, and general). The demonstration further illustrates how an eTMF archive can be viewed in a web browser, even offline, emphasizing the standard's focus on the backend data exchange rather than prescribing application presentation. The discussion concludes with a strong call for industry participation in reviewing and commenting on the specification draft to ensure its broad usability and adoption.

Key Takeaways:

• Urgent Need for eTMF Standards: The pharmaceutical industry's shift from paper to electronic systems for clinical trials necessitates robust data standards to improve productivity, reduce time-to-market for new drugs, and enable efficient information exchange.
• OASIS as a Global Standard Body: OASIS was chosen for this initiative due to its status as a leading global standards organization for interoperable technology, known for its open processes, transparency, and broad industry participation.
• Addressing Industry Challenges: The OASIS eTMF standard aims to resolve issues like data silos, high maintenance costs, and vendor lock-in by providing a common, open framework for data exchange.
• Foundation on Open Web Standards: The standard is built upon established web standards, including the W3C RDF/XML for machine-readable taxonomies and the CMIS (Content Management Interoperability Standard) for seamless integration with enterprise content management systems.
• Comprehensive Requirements: The standard's core requirements include support for paperless transactions, digital signatures, a standard-based controlled vocabulary, model flexibility, open standards integration (CDISC, NCI, FDA), multi-media support, portability (cloud/offline), localization (Unicode), and built-in audit trails via XML metadata.
• Three-Layered Architecture: The eTMF architecture comprises a Classification System Layer (content model, metadata, rules), a Vocabulary Layer (standardized terms from NCI, CDISC, HL7), and a Web Technology Layer (interoperability, digital signatures, business process modeling).
• Key Deliverables: The initiative's main outputs include a published controlled vocabulary, a machine-readable taxonomy (RDF/XML), and a content model/data model for information exchange, alongside guidance for CMIS integration.
• Compatibility with TMF Reference Model: The OASIS eTMF standard is designed to support existing industry models, such as the TMF Reference Model, through flexible mapping of terms and display labels, ensuring a smooth migration path.
• NCI Thesaurus as Vocabulary Repository: The National Cancer Institute (NCI) Thesaurus serves as the global repository for the controlled vocabulary, providing curated terms with unique codes, definitions, and URLs, widely used across health science metadata.
• Focus on Backend Interoperability: OASIS focuses on standardizing the backend application services and data services layers, allowing application vendors the flexibility to design their own presentation layers while ensuring underlying data exchange consistency.
• Future Vision for Clinical Trials: The long-term objective is to foster broader system interaction, platform-agnostic data exchange (cloud, network, offline), and global communication within a compliant framework to accelerate the delivery of effective therapies.
• Call for Industry Engagement: Technical professionals and organizations are strongly encouraged to download the specification and code, review the work, and provide specific, solution-focused comments to refine the standard before its final publication.

Tools/Resources Mentioned:

• OASIS Website: For downloading the eTMF specification, code, and submitting comments.
• National Cancer Institute (NCI) Thesaurus: A global terms database of controlled vocabulary terms, used as the repository for eTMF terms.
• Protege: A free, open-source taxonomy editing tool from Stanford University for working with RDF/XML models.

Key Concepts:

• eTMF (Electronic Trial Master File): An electronic system for managing and storing essential documents and data related to a clinical trial, moving away from paper-based TMFs.
• OASIS (Organization for the Advancement of Structured Information Standards): A non-profit consortium that drives the development, convergence, and adoption of open standards for the global information society.
• CMIS (Content Management Interoperability Standard): An OASIS standard that defines a web services interface allowing different content management systems to interoperate.
• RDF/XML (Resource Description Framework / Extensible Markup Language): A W3C standard for describing information and creating machine-readable taxonomies, used for the eTMF specification's underlying data model.
• NCI Thesaurus: A comprehensive, curated vocabulary and ontology for cancer and biomedical sciences, utilized by the eTMF standard for its controlled vocabulary.
• TMF Reference Model: A widely adopted, industry-driven model that provides a standardized structure for the Trial Master File, which the OASIS eTMF standard is designed to support and integrate with.