Re: [etmf] Name of the OASIS eTMF Standard Technical Committee

To the TMF Steering Committee:

Thank you for your interest in the OASIS eTMF Standard TC's work.

This initiative is called the OASIS eTMF Standard TC because we are developing an ISO standard for eTMF content classification and exchange. The good news is that the core work of the OASIS eTMF Standard TC's group will be based on published standards, wherever possible.

Per the Charter, our work is divided into two phases:

Phase 1, we are developing a standards-based content classification taxonomy, core metadata and a content model exchange format that is based on W3C standards. This phase is not intended to address any specific domain, and is focused on a technology architecture model that would allow any labels or terms to be used for classification and metadata tagging. This phase will develop a minimal set of controlled vocabulary for content classification, file properties, and system level characterizations that are operating system and application independent/neutral. Key metadata needed in this phase is focused on areas such as file properties. A deep set of details on the ontology, content models and metadata work of the TC can be viewed online by anyone and I encourage you to become familiar with the technology component in Phase 1.

Phase 2, we will develop classification terms and metadata for the eTMF domain. The group will discuss and add eTMF domain specific terms to the model. This phase will develop a controlled vocabulary for the eTMF domain.

We are not developing any specific system or application, other than a specification with a published set rules and policies on how to classify and exchange eTMF content through the cloud or through any other standards-based format, as per the charter.

As outlined in previous meetings, our goal is to develop a 'standard based on standards' so we will primarily reference work from published technology standards bodies such as W3C as well as BioPharma standards groups NCI Thesaurus, CDISC, BRIDG, HL7, W3C, and others. The TMF RM work has been and will continue to be considered in our efforts. We encourage the TMF RM steering committee's participation in the work of the OASIS eTMF Standard TC.

OASIS is the ideal format for this standards initiative for many reasons, including broad participation by many other global standards bodies, its track record of work resulting in ISO standards, open participation from industry participants, vendors and stakeholders across a broad range of industries.

We truly welcome your participation in this group. Per TC policy, comments and feedback will be logged and can be addressed at TC meetings by the group. This issue will be addressed at the beginning of the next meeting on 2-17 by Chet Ensign of OASIS.

Thank you,

Zack Schmidt

OASIS eTMF Standard TC Chair

On Wed, Feb 12, 2014 at 3:15 AM, Eldin Rammell, Rammell Consulting <eldin.rammell@rammell.com> wrote:

Sent on behalf of the TMF Reference Model Steering Committee:

Following discussion amongst the TMF Reference Model Steering Committee, it was felt that confusion within the industry is resulting from the omission of the word “interoperability” from the Charter title and name of the OASIS eTMF Standard Technical Committee, and is likely to continue to do so.

It is clear from the Charter that the objective of the Technical Committee is to achieve interoperability and the purpose of the Standard is to achieve this goal. However, omission of the word “interoperability” leads the casual reader to conclude that the Technical Committee is developing a standard for an eTMF system itself. For example, an eTMF Standard would require standard content, a standard naming convention for its artifacts and a standard structure (taxonomy). An interoperability standard does not mandate this and we understand it is not within the scope of the Technical Committee to enforce this as part of the standard.

The Steering Committee have received feedback from members who are under the impression that the OASIS eTMF Standard Technical Committee is charged with developing a standard that will replace the TMF Reference Model, including mandatory artifact naming and mandatory file structure. This misunderstanding is therefore likely to have a negative impact on participation on said Technical Committee.

As per OASIS rule 2.11 “TC Charter Clarification”, we are requesting that a motion be put to the Technical Committee to amend the name of the TC within the Charter to “Electronic Trial Master File (eTMF) Interoperability Standard Technical Committee”. We note that other OASIS Technical Committees working on interoperability standards have included the word “interoperability” in the name of their TC.

Sent on behalf of the TMF Reference Model Steering Committee

Karen Redding (Chair)
Steve Scribner (Vice-chair)

Eldin Rammell (Secretary

12 February 2014.

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