2014 07 22 11 00 Understanding the OASIS eTMF Specification for Non Technical Professionals

This video provides an in-depth exploration of the OASIS Electronic Trial Master File (eTMF) Specification Version 1.0 CSD01, specifically tailored for non-technical clinical professionals. The webinar, presented by Jennifer Alpert Pulch (OASIS eTMF Technical Committee co-chair and CEO of Carlex) and Sharon Ames (OASIS eTMF TC member and Director of Enterprise Solutions at Nexto), aims to demystify the specification and encourage broader industry participation in its development. The core problem addressed is the pervasive lack of interoperability—or "islands of automation"—within the clinical trials ecosystem, where various stakeholders use disparate systems and terminologies, leading to increased costs, time, and data integrity challenges during information exchange.

The presentation details the purpose and architecture of the OASIS eTMF standard, emphasizing its role in enabling seamless exchange of digital records between collaborator systems. It highlights that the standard is built upon existing frameworks and regulatory guidelines (including EMA, FDA, and ICH), utilizing an open systems approach that is independent of specific operating systems or programming languages. A key aspect discussed is the use of a controlled metadata vocabulary, curated by entities like the National Cancer Institute (NCI) Enterprise Vocabulary Services, to create a universal "machine code" (RDF/XML) that allows different eTMF systems to communicate effectively, regardless of their front-end display labels or even natural language differences. This backend standardization is compared to HTML, which enables universal web viewing despite diverse underlying technologies.

The speakers also outline the current status of the specification, which is in a public review period, and detail how clinical professionals can provide impactful feedback. They stress that while the immediate impact is primarily on vendors who will implement the standard, the long-term benefits for sponsors, Contract Research Organizations (CROs), and ultimately sites, will be significant in terms of data portability, quality retention, and efficiency. The webinar concludes by emphasizing that the standard is an evolving process, requiring ongoing collaboration and input from diverse industry groups to meet changing industry needs, with future versions anticipated to further enhance its capabilities and unlock new potentials like big data analysis of historical clinical trial data.

Key Takeaways:

• Addressing Interoperability Challenges: The primary goal of the OASIS eTMF Specification is to overcome the "islands of automation" in clinical trials, where disparate systems and terminologies hinder the seamless exchange of Trial Master File (TMF) information, leading to increased costs and time.
• Data Portability as a Core Benefit: The standard is designed to enable "data portability," allowing for the easy and reliable migration of digital records between different companies and systems, such as between sponsors and CROs, or during company acquisitions.
• Significant Cost and Time Savings: By standardizing data exchange, the eTMF specification is expected to increase productivity, reduce the time and effort spent on data migration, and improve overall efficiency in clinical trial operations.
• Foundation on Existing Standards and Regulations: The eTMF standard is not reinventing the wheel; it integrates existing regulatory guidelines from the EMA, FDA, and ICH, as well as technology standards like Business Process Modeling (BPM), CMIS, and digital/electronic signatures.
• Open Systems Approach: The specification is developed with an open systems approach, making it independent of any specific operating system, software application, or computer language, which provides flexibility for vendors and their customers.
• Flexible Customization for Organizations: While providing a standard framework, the specification allows organizations to integrate their unique needs by adding or editing organization-specific metadata terms and content items, ensuring flexibility while maintaining interoperability.
• Backend Technical Standard, Vendor-Controlled Frontend: The OASIS eTMF Technical Committee focuses on the backend architecture and machine code (RDF/XML) that enables systems to communicate. Vendors will then dictate what the end-user sees through display labels, tailoring solutions to their customers' specific needs.
• Leveraging Controlled Vocabularies: The standard draws heavily on controlled vocabularies, particularly from the National Cancer Institute (NCI) Enterprise Vocabulary Services, which curates global health sciences terminologies, ensuring broader interoperability and avoiding conflicts.
• Impact on Stakeholders: Vendors are most immediately impacted as they implement the standard into their products. Sponsors and CROs will benefit from improved data portability and quality. The impact on clinical sites is currently limited, though future vendor solutions may integrate site-level permissions.
• Importance of Public Review and Specific Feedback: The specification is undergoing a public review period (e.g., 45 days ending August 8th for the initial draft). Stakeholders are encouraged to provide specific, solution-oriented comments, focusing on their areas of expertise, such as suggesting synonyms for metadata vocabulary terms.
• Evolutionary Nature of the Standard: The development of the eTMF standard is an ongoing, evolving process. The initial version is a foundational step, with future versions anticipated to incorporate additional feedback and adapt to changing industry needs.
• Long-Term Strategic Benefits: Beyond immediate operational efficiencies, a fully implemented eTMF standard could enable "big data analysis" of historical clinical trial data, potentially leading to new learnings and treatments by breaking down data silos.
• Vendor Adoption Timeline: Full vendor adoption and widespread implementation are expected to take a year or more after the standard is finalized, as vendors will need time to assess, integrate, and roll out the new capabilities.
• Comparison with DIA TMF Reference Model: The TC has attempted to map the eTMF specification to the DIA TMF Reference Model, and encourages reviewers to provide further input on this comparison, noting that the eTMF specification includes technical elements (like business processes, e-signatures) that may not be present in the reference model.

Key Concepts:

• OASIS Open: A leading global standards organization for technical specifications, fostering open processes and publicly viewable development.
• eTMF Specification: A technical standard for the Electronic Trial Master File, designed to enable interoperability and seamless data exchange in clinical trials.
• Interoperability / Data Portability: The ability of different computer systems or software to exchange and make use of information, specifically referring to the ease of migrating clinical trial data between various systems and organizations.
• Controlled Vocabulary: A carefully selected list of words and phrases used to tag information, ensuring consistency and precision in data classification and retrieval.
• Metadata Vocabulary: A specific set of controlled terms and definitions used to describe data within the eTMF, forming the basis for machine-to-machine communication.
• TMF Reference Model: A widely recognized, standardized structure for the Trial Master File, providing a common understanding of TMF content and organization.
• RDF/XML Machine Code: A technical standard for data interchange on the Web, used in the eTMF specification to encode metadata and enable systems to "speak" to each other.
• CMIS (Content Management Interoperability Services): An OASIS standard that defines a web services interface for content management systems, enabling additional interoperability for the eTMF.
• NCI Enterprise Vocabulary Services (EVS): A comprehensive repository of biomedical vocabularies and ontologies, used by the eTMF specification to curate its controlled vocabulary and ensure broad health sciences compatibility.

Examples/Case Studies:

• Acquisitions: The standard offers a significant advantage for companies undergoing acquisitions, allowing for easier and more reliable incorporation of eTMF systems or data from acquired entities into existing systems.
• Sponsor-CRO Data Sharing: The standard directly addresses the challenges faced by sponsors and CROs in sharing clinical trial information, enabling seamless data exchange regardless of the specific eTMF systems used by each party.