September 23, 2015
OASIS eTMF Standard Draft Approved

OASIS eTMF Standard Draft Approved

On June 25th, the global clinical trials industry took a giant step toward global clinical trial data standardization with OASIS Open’s publication of the OASIS eTMF Committee Specification Draft V1.0 for clinical trial regulated content management interoperability.  SureClinical is the first eTMF vendor to announce native support for RDF/XML, the core technology specified in the OASIS eTMF Committee Specification Draft.

Designed as a standard based upon standards, the draft OASIS eTMF Specification is designed to facilitate information exchange between clinical trial systems through standard web-based technologies, a controlled vocabulary and a published taxonomy for the clinical trials domain.  The draft OASIS eTMF Specification promises to accelerate clinical trials processes, and will move the industry from manual, paper-based processes to automated fully 100% digital operations.

For those who are unfamiliar with OASIS, they are the global not-for-profit, international consortium that drives the development, convergence and adoption of open standards technologies.  The OASIS Open consortium has more than 5,000 participants representing over 600 organizations and individual members in 100 countries.  Global document system vendor organizations such as Alfresco, IBM, Microsoft, Oracle and many others are contributors to OASIS and members of OASIS, demonstrating the long-term commitment vendors have made toward interoperable systems and data portability.

To ensure that data is portable between document management systems, the OASIS eTMF Standard initiative utilizes a web standard technology known as RDF/XML.  In much the same way that the HTML language is used as the basis for the internet browsing of content through any web browser from multiple browser vendors, RDF/XML is used to publish clinical trial content that can be shared across systems and networks.    RDF/XML technologies, also known as ‘linked data,’ is being adopted by a broad group of BioPharma organizations.  CDISC, FDA/PhUSE and National Cancer Institute and others involved in BioInformatic systems development are using RDF-based linked data technologies to facilitate interoperability.   With the OASIS eTMF Standard Technical Committee’s adoption of RDF/XML as the standard for eTMF content and record sharing,  BioPharma companies will be able to seamlessly exchange regulated documents with a variety of clinical systems saving invaluable time from study-startup through completion.

In the eTMF systems area, SureClinical is the first eTMF applications software vendor to announce support for RDF/XML technologies, enabling customers to minimize eTMF application deployment risk through the deployment of standards-based BioPharma content exchange technologies.   SureClinical’s cloud-based platform enables users to export, import or exchange structured content between any vendor application that has RDF/XML support, thereby protecting customers from vendor lock-in.

The controlled vocabulary used in the OASIS eTMF Standard Technical Committee was recently published by the National Cancer Institute’s Enterprise Vocabulary Services (NCI) and is available online at the NCI Thesaurus term repository at http://ncit.nci.nih.gov/.  

NCI Thesaurus is 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.  NCI Thesaurus repository terms are used by organizations globally such as FDA, CDISC, HL7, ICD-10, SNOMED, WHO and many others as a repository and resource for open source controlled vocabulary development.   NCI Thesaurus is an open organization that ensures term consistency and interoperability across domains, and participation and use of the terms are open to anyone worldwide.

Download OASIS eTMF Standard Draft Specification

As part of the eTMF standardization effort toward a global ISO standard for clinical trial data exchange, The OASIS eTMF Standard TC will seek public review and comment on its recent draft publication which is available as a package 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-

Comments and Public Contributions Welcome

All interested parties are welcome to contribute or comment on the draft OASIS eTMF Specification.   Additional information is available through OASIS at:
https://www.OASIS-open.org/committees/etmf

As part of the OASIS eTMF Standard TC effort to move toward a global ISO standard for the clinical trials area, adoption of NCI as the repository for eTMF terms is a significant step forward that ensures that a single repository of interoperable terms will be available for clinical trial software, systems and study stakeholders globally.

SureClinical congratulates the OASIS eTMF Standard members who participated in the development of this important specification, and welcomes the benefits that it will offer all sponsors, research organizations, vendors and stakeholders involved in clinical trial regulated content management.  SureClinical is proud to be a founding member and sponsor of this important initiative.

For additional details on how the OASIS eTMF Specification can help minimize risk in your clinical trial operations,  see SureClinical’s web FAQ, ‘OASIS eTMF Standard FAQ’ published at: https://sureclinical.com/oasis-etmf-standard-faq/

 

OASIS eTMF Standard FAQ

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:

Download Oasis eTMF Draft Spec:

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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