2014 07 21 16 00 Understanding the OASIS eTMF Specification An Overview for TMF RM Members

This video provides an in-depth exploration of the OASIS eTMF Specification, offering a non-technical overview tailored for members of the TMF Reference Model community. The main purpose is to introduce the recently released Electronic Trial Master File (eTMF) Specification Version 1.0 CSD01, explain its core objective of achieving interoperability within the biofarma industry, and encourage public participation in its review process. The speakers, Jennifer Pulch (Chair of the OASIS eTMF Technical Committee) and Fran Ross (TC member), along with Michael Agard, emphasize the critical need for a standardized technical framework to overcome the challenges of data exchange between disparate eTMF systems used by sponsors and Contract Research Organizations (CROs).

The presentation delves into the "why" behind eTMF interoperability, highlighting the prevalent issue of "islands of automation" where different organizations use varying systems and nomenclature, making data migration and collaboration complex and costly. The OASIS eTMF standard aims to resolve this by creating a technical standard based on open systems principles, independent of specific operating systems, software applications, or computer languages. It provides broad flexibility while ensuring standardization, allowing for company-specific metadata terms and content items to remain interoperable through a defined set of rules for editing metadata. This flexibility is crucial as every company has unique needs, but the underlying standard ensures seamless data exchange.

The speakers clarify what the eTMF standard is and is not. It is a detailed specification for application developers, acting as a technical roadmap for data portability, comprising a content model, data model, machine code (OWL), and controlled vocabulary. Crucially, it is not a new TMF model for end-user content organization, nor does it dictate document names as viewed by users. Instead, it provides the backend architecture that allows vendors to develop products with varied front-end displays while maintaining interoperability. The standard integrates existing document formats (over 1,800 media types) and supports various system approaches (offline, network, cloud), ensuring broad applicability and non-restrictiveness. The ultimate goal is to increase efficiency, accuracy, and reduce costs in clinical trial operations, with a longer-term vision of enabling better data analysis and repurposing from past trials.

Key Takeaways:

• The OASIS eTMF standard is designed to enable machine-to-machine interoperability and data portability for Electronic Trial Master File (eTMF) systems within the pharmaceutical and life sciences industries. This addresses the significant challenge of data exchange between sponsors and CROs using different TMF systems.
• The core problem the standard aims to solve is the "islands of automation" effect, where disparate systems and varying nomenclature lead to complicated and expensive data migration processes, hindering efficient clinical trial operations.
• Guiding principles for the standard include being a technical standard based on existing open standards, adopting an open systems approach independent of specific software or languages, and remaining open source while offering flexibility for unique organizational needs.
• The eTMF specification comprises three main components: a content model, a data model, and a machine code (OWL), all supported by a controlled vocabulary that includes domain-specific eTMF metadata. These components provide the architectural blueprint for application developers.
• It's important to understand that the eTMF standard is not a new TMF model for end-user content organization, nor does it dictate document names as seen by users. Instead, it provides the backend technical framework that allows for front-end customization by vendors while ensuring underlying interoperability.
• The standard is non-restrictive regarding document formats, integrating over 1,800 media types (e.g., JPEG, Microsoft, Adobe), and supports various system approaches including offline, network, and cloud-based solutions, allowing vendors broad implementation flexibility.
• The TMF Reference Model serves as the end-user taxonomy, and the eTMF standard integrates this taxonomy with codes and ontology for vendors to build interoperable systems, ensuring alignment between business content and technical implementation.
• The standard's adoption is expected to greatly benefit sponsors and CROs by eliminating vendor lock-in, enabling seamless data exchange, increasing efficiency, reducing costs associated with data migration and re-coding, and improving overall data quality and compliance.
• The Committee Specification Draft (CSD) is currently open for public review, with a strong emphasis on gathering feedback for the metadata vocabulary. This is a critical opportunity for industry experts to ensure the standard is accurate and comprehensive.
• The technical committee encourages TMF Reference Model members and other industry experts to actively participate in the public review, particularly by focusing on the metadata worksheet to identify missing terms, inaccuracies, or potential compliance issues.
• When providing feedback, commenters are urged to be specific, provide solutions rather than just criticisms, and focus on areas of their expertise to maximize impact on the standard's development.
• The development of the eTMF standard is an evolving process; this first version lays the groundwork, and future iterations will incorporate learnings from implementation and adapt to changing industry needs, requiring ongoing cooperation.
• The long-term vision extends beyond immediate operational efficiencies to include enhanced data analysis capabilities from past clinical trials, facilitating data repurposing, and ultimately contributing to scientific learning and innovation.
• The standard aims to support compliance, with discussions around integrating relevant regulatory requirements, such as those from the FDA and EMA, and aligning with other standards bodies like HL7.

Tools/Resources Mentioned:

• OASIS Open: The global standards organization responsible for developing the eTMF specification.
• TMF Reference Model LinkedIn Group: Suggested platform for community peers to discuss the eTMF standard and frame comments.
• OWL (Web Ontology Language): The machine code component of the eTMF specification, used by application developers.

Key Concepts:

• eTMF (Electronic Trial Master File): The digital repository for essential documents and records related to a clinical trial, ensuring compliance and data integrity.
• Interoperability: The ability of different information systems, devices, or applications to connect, communicate, and exchange data in a coordinated manner, without special effort from the end user.
• Data Portability: The ability to move data from one system or application to another easily and seamlessly, maintaining its integrity and usability.
• TMF Reference Model: A standardized taxonomy and structure for organizing TMF documents, widely adopted by the industry for content organization.
• Controlled Vocabulary: A standardized and organized set of words and phrases used for indexing, tagging, and retrieving information, ensuring consistency across systems.
• Committee Specification Draft (CSD): A preliminary version of a technical specification released by OASIS for public review and input before finalization.