OASIS Electronic Trial Master File (eTMF) Standard TC


Overview and Process

  1. What is the eTMF Standard TC and why has it been formed?

    The OASIS eTMF Standards Technical Committee (TC) was developed in response to a growing global need for a technology standard to support formal representation and exchange of clinical trials eTMF information for enhanced information interoperability among stakeholders. Members of the eTMF Standards TC are individuals from government, industry and academic research who have agreed to work together to drive the development of an eTMF standard in an open and democratic process.

  2. What will the requirements for an eTMF standard be based on?

    The eTMF Standard TC will gather, summarize and prioritize business and technical requirements from TC members, industry and academia for guidance in the creation of a clinical trial content exchange format. We will seek input during the initial stages of this work from key industry groups including, but not limited to, CareLex, clinical trial sponsors, Document & Records Management DIA Community, NCI Thesaurus, SAFE-BioPharma, technology vendors, and TransCelerate BioPharma. Input will be incorporated into the general statement of need.

  3. Which specifications have been identified as initial candidates to serve as a starting point for TC's standardization effort?

    The TC will consider as initial inputs into the initiative the following:

    Other contributions will be accepted for consideration by the TC without any prejudice or restrictions and will be evaluated based on technical merit.

  4. Does the proposed standard compete with the TMF Reference Model?

    No. The eTMF Standard TC welcomes participation from members of the DIA Document & Records Management Community and is committed to open communication between these two initiatives. TMF classifications and regulatory document requirements listed in the TMF Reference Model will be used in the new eTMF standard as far as is practical. If there are technical reasons for divergence, a cross-reference between the TMF RM and the eTMF Standard will be published.

  5. How will the eTMF Standard differ from the TMF Reference Model?

    The eTMF TC intends to provide a technical standardfor clinical trial content classification and exchange. The standard will incorporate support for required documents from multiple regulatory agencies, support for published vocabulary references and standards-based industry terms, and will be built and delivered on a standards-based technology platform. The eTMF standard will include support for multiple industry-adopted technology standards to promote interoperability across diverse computing platforms and cloud networks within the clinical trials community. To facilitate a transition to electronic and cloud-based information exchange, minor modifications of the TMF Reference Model classification terms may need to be made. To provide interoperability with the TMF Reference Model, the eTMF standard will contain a mapping of eTMF standard classification terms to TMF Reference Model classification terms.

  6. The following resources have been identified as potentially applicable to design decisions made in development of the eTMF standard:

    Regulatory Guidelines:

    • EU EMA
    • FDA
    • ICH

    Published Vocabulary References:

    • BRIDG
    • CareLex
    • Dublin Core
    • HL7
    • NCI Thesaurus
    • TMF Reference Model

    Technology Standards:

    • Business Process Model and Notation (BPMN)
    • CMIS
    • Digital Certificate Signing (PKI x.509)
    • HTML
    • RDF/XML
    • XML
  7. Why is this standards effort being undertaken at OASIS?

    This is a technical project focused on electronic content interoperability and exchange. OASIS has a proven track record in leading technical standards development initiatives in content management. Most eTMF applications today are based on Electronic Document Management Systems (EDMS). Many major EDMS vendors are OASIS members. Because data exchange often relies on software systems, a proven standards development organization with strong software vendor support is critical for the development of new standards. OASIS standards are accepted by governments worldwide and are often adopted as ISO, ITU or IEC standards.

  8. How does the eTMF Standard TC relate to the work of CDISC?

    We see the efforts of the OASIS eTMF Standard TC and the Clinical Data Interchange Standards Consortium (CDISC) as being complementary. The eTMF Standard TC seeks to enable interoperable exchange of clinical trial content via electronic content management systems (CMS) – in other words, sharing documents via the Internet. In contrast, CDISC develops clinical data standards that support the acquisition, exchange, submission and archive of clinical research data and metadata. Where CDISC seeks to build harmony in how data are recorded and exchanged to ensure information system interoperability to improve medical research, the OASIS eTMF Standard TC works to ensure that research-related documents can be accessed through electronic mediums, such as the web.

  9. How does the eTMF Standard TC relate to the work of HL7?

    Health Level Seven (HL7) is represented on the OASIS Electronic Trial Master File (eTMF) Standard TC, and is a long-standing OASIS Liaison organization. HL7 believes the OASIS initiative to support formal representation and exchange of clinical trials eTMF information is well aligned with the Biomedical Research Integrated Domain Group (BRIDG) Model, which is both an HL7 standard and a CDISC standard.

  10. How does the eTMF Standard TC's work relate to the NCI Thesaurus and the BRIDG Model?

    The eTMF Standard framework will be a "standard based on standards." Core controlled terms used will be sourced primarily from the NCI Thesaurus, which includes terms from the Biomedical Research Integrated Domain Group (BRIDG) Model, the product of a collaboration among CDISC, NCI, HL7, and FDA. Additional eTMF domain classification terms, which are not present in BRIDG, will be developed by the OASIS TC in the second phase of its work.

  11. Who are the intended TC participants and users of eTMF?

    The TC is open to participation from all interested parties. The work will be particularly valuable for people involved in: software design and development; life science vocabularies such as those from HL7, NCI Thesaurus, BRIDG and others; business process modelling; digital signature technologies; government agency policy development related to the BioPharma Systems and or IT area; and content classification systems.

  12. What participation opportunities are available to OASIS TC Members?

    The process of developing a standard involves creating a written specification, which involves reviewing, writing/commenting and editing. Initially, the group will evaluate all available candidate specifications as a starting point. Then members will be asked to review, edit and develop contributions as needed to enhance the selected candidate eTMF specification. TC work will be conducted via a publicly archived mailing list and regular teleconference meetings.

  13. What other costs are there?

    The only requirement for participation in the eTMF TC is OASIS membership. OASIS offers several levels of membership with discounted dues for government agencies, academics, associations, and small companies. Personal membership is also available. Dues are outlined here. NOTE: there is no additional cost for employees of current OASIS member organizations (see list).

  14. What is the approval process?

    Each person who participates in the eTMF TC will be eligible to vote at the Committee level. Once the TC approves a specification, it is submitted to the OASIS membership at-large for final ratification as an OASIS Standard. In this ballot, each organizational member has one vote.