BOSTON--(BUSINESS WIRE)--The pharmaceutical community, health care organizations, and software providers are coming together at the OASIS open standards consortium to define a machine-readable content classification standard for the interoperable exchange of clinical trial data via content management systems. The work of the new OASIS Electronic Trial Master File (eTMF) Standard Technical Committee will promote interoperability across diverse computing platforms and cloud networks within the clinical trials community.
“We’re responding to a growing global need for a technology standard that can support formal representation and exchange of clinical trials eTMF content. Our goal is to enhance information interoperability among stakeholders,” said Zack Schmidt of SureClinical, chair of the OASIS eTMF Standard Technical Committee. “The breadth and stature of the organizations advancing this work clearly indicate there’s a real need for this standard.”
The OASIS eTMF work will enable content to be exchanged through cloud, networks, or physical media. Members will define an eTMF content classification model (including a standards-based vocabulary and content classification ontology), a set of content classification policies, and an eTMF Data Model.
The eTMF Standard framework will be a 'standard based on standards.’ It will support required documents from multiple regulatory agencies, published vocabulary references, and key industry standards. The OASIS work will be take place in two phases. The technology phase will build on the content classification specification and core terms contributed to OASIS by CareLex with input from the National Cancer Institute’s Enterprise Vocabulary Services. The vocabulary phase will build on the TMF Reference Model produced by the Document and Records Management DIA Community. It will utilize a W3C semantic web-based ontology to classify content as well as a controlled vocabulary 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 the U.S. FDA. Additional eTMF domain classification terms, some of which are not present in BRIDG, will be developed by the OASIS Technical Committee.
New members are encouraged to join the OASIS eTMF Standard Technical Committee at any time. Archives of the work are accessible to both members and non-members, and OASIS invites public review and comment on the work.
Support for OASIS eTMF Standard
Forte Research Systems
“As a provider of specialized
software serving organizations engaged in clinical and translational
research, Forte Research Systems is committed to the development and
adoption of relevant technology standards like eTMF and to supporting
the work of standards organizations like OASIS. We are particularly
enthusiastic about this new OASIS effort because it promises a
consistent organization and structure of TMF content enabling the
exchange of common TMF elements with other software systems in this
space.”
--Tony O'Hare, PhD, Co-Founder, VP Operations, & Chief
Collaboration Office, Forte Research
Health Level Seven (HL7)
“HL7 is pleased to continue its
collaborative efforts with OASIS by participating in the Electronic
Trial Master File (eTMF) Standard. This initiative to support formal
representation and exchange of clinical trials eTMF information is well
aligned with the existing standard that was jointly developed by HL7 and
CDISC for the Regulated Clinical Research Information Management (RCRIM)
Biomedical Research Integrated Domain Group’s Domain Analysis Model for
the clinical research domain and also leverages a long standing HL7
relationship with not only CDISC and OASIS but also the FDA and NLM.”
--John
Quinn, CTO, HL7
Oracle
“As a leading provider of life science solutions,
Oracle recognizes that developing standards to support data exchange and
interoperability is critical to the smooth flow of data between systems
that participate in the clinical trial life cycle. The ability for eTMF
systems to easily consume Trial Master File documents and exchange those
documents seamlessly will greatly improve sponsor management of trial
documentation and speed up preparation of trial artifacts used in
regulatory submissions. Oracle is pleased to participate in this
initiative.”
--Don Deutsch, VP, Chief Standards Officer, Oracle
SureClinical
"As a founding sponsor of the OASIS eTMF
Technical Committee, SureClinical is excited to see the widespread
industry adoption of OASIS open standards. As a provider of cloud-based
eTMF applications, we are proud to partner in the development of this
critical BioPharma initiative that accelerates delivery of new therapies
globally by facilitating the paperless exchange of clinical trial
content. We look forward to championing the OASIS eTMF Standard by
implementing a compliant SureTrial® eTMF Cloud solution."
--Zachariah
Schmidt, CEO, SureClinical
Additional information
OASIS eTMF Technical Committee
https://www.oasis-open.org/committees/etmf/
OASIS is a non-profit, international consortium that drives the
development, convergence and adoption of open standards for the global
information society. OASIS promotes industry consensus and produces
worldwide standards for cloud computing, content technologies, security,
privacy, M2M, IoT, energy, and other areas. OASIS open standards offer
the potential to lower cost, stimulate innovation, grow global markets,
and protect the right of free choice of technology. OASIS members
broadly represent the marketplace of public and private sector
technology leaders, users, and influencers. The consortium has more than
5,000 participants representing over 600 organizations and individual
members in 65+ countries.
http://www.oasis-open.org
