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What is the OASIS eTMF Standard Draft Specification?

  • The OASIS eTMF Standard is a technology and controlled vocabulary specification that enables seamless exchange of electronic content between clinical trial Sponsors, CROs and investigators, regardless of the Electronic Document Management System used.
  • Its a technology system framework for Trial Master File content sharing, a controlled vocabulary maintained by the National Cancer Institute, and an open source machine readable taxonomy based on industry technology standards.
  • A flexible set of rules and policies for how regulated clinical trial electronic content can be named, classified, exchanged and archived via the  cloud and and offline media

Who is involved in this initiative?

  • OASIS Open – As a leading global standards organization focused on making technologies work together through standards, OASIS represents over 600 organizations and has over 5,000 members worldwide.  Standards bodies and regulatory agencies FDA and EMA have agreed to provide review and comment on the work of the OASIS eTMF standards group.   Global system vendor organizations such as IBM, Microsoft, Oracle and many others are contributors and members of OASIS, demonstrating the long-term commitment vendors have made toward interoperable systems and data portability.
  • The National Cancer Institute – NCI recently published the controlled vocabulary terms used in the OASIS draft eTMF specification in the NCI Thesaurus, a public term repository used by life science and health care standards globally in systems development.
  •  The Electronic Trial Master File (eTMF) Specification Version 1.0 incorporates global technical standards and controlled terms developed by BRIDG (CDISC/FDA/HL7), CareLex, Dublin Core, HL7, National Cancer Institute, the TMF Reference Model, and W3C.

What problem is being solved and why is this important?

  • The growth of eTMF based systems in clinical trials parallels the growth of the internet.  Multiple organizations and systems are attempting to speak with each other and share information, yet without common ground. The eTMF Standard provides a common ground for systems to communicate and share data.  In the technology area, this concept of seamless data sharing is known as ‘interoperability.’
  • Stakeholders involved in Clinical trial studies are transitioning from paper-based systems to cloud-based digital systems for trial master file management.  Cloud, mobile and new electronic signing technologies offer new productivity opportunities that can streamline clinical trial study startup.  However, without a standard or specification for how electronic clinical trial master file data is classified and exchanged, proprietary, non-standard vendor systems and solutions will make it increasingly expensive and time consuming for stakeholders to implement and integrate eTMF technology solutions because of a lack of interoperability.  With a standard, implementing organizations lower compliance risk, lower costs and gain flexibility through vendor interoperability.

What is being offered with the OASIS eTMF Standard?

  • In order to enable clinical trial stakeholders to rapidly achieve the benefits of electronic trial master file systems and technologies,  the OASIS eTMF standards body has developed an eTMF system specification using an open architecture and technology neutral approach.  As a standard built upon standards, the OASIS eTMF Standard specification includes the following components:
  • OASIS eTMF Standard Specification The OASIS eTMF standard specification publishes details of a content classification reference model with rules, policies and procedures for how content can be shared and customized for clinical trials.   The Content classification system layer uses machine readable, web standards based technologies that offer flexibility and open standards in a vendor neutral approach.
  • OASIS eTMF Standard controlled vocabulary – Terms used in the OASIS eTMF Standard were sourced from CareLex, Dublin Core, HL7, CDISC, TMF Reference model and other groups, which have been reviewed by the OASIS eTMF Standard team, and have been published by the National Cancer Institute’s Enterprise Vocabulary Services online public term repository resource, NCI Thesaurus.  NCI Thesaurus is the standard for global clinical trial term development and curation, and is used by agencies and standards groups such as FDA, EMA, HL7, CDISC, ICD and many others globally in clinical trials and healthcare.
  • Support for the TMF Reference model — OASIS eTMF Standard controlled vocabulary terms were reviewed by members of the TMF Reference Model community to provide a cross-reference between terms in the OASIS eTMF Standard controlled vocabulary and terms in the TMF Reference Model.   Published in the OASIS eTMF Standard controlled vocabulary,  the cross-referencing resource is designed to provide a path forward to groups who may have implemented the TMF Reference model terms and are interested in migrating to the OASIS eTMF Standard for existing or new clinical studies.
  • OASIS eTMF Standard Content Model –  The OASIS content classification model taxonomy and  controlled vocabulary are published in a standards-based, machine readable format that facilitates interoperable sharing of clinical trial eTMF data between systems and organizations.  The OASIS eTMF Standard Content Model is published using the web standard RDF/XML, used by CDISC, FDA, NCI and other organizations to ensure open standards interoperability.   The draft content model ontology has been published at OASIS.

How can I access OASIS eTMF Standard Resources?

Public access to the complete set of resources in the OASIS eTMF Standard Draft Specification is available to all for free download from Oasis at:

https://www.oasis-open.org/news/announcements/45-day-public-review-for-electronic-trial-master-file-etmf-specification-version-

How can I comment on the OASIS eTMF Standard Draft Specification?

Comments may be submitted to the TC by any person through the use of the OASIS TC Comment Facility which can be used by following the instructions on the TC’s “Send A Comment” page, or directly at:

https://www.oasis-open.org/committees/comments/index.php?wg_abbrev=etmf

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