Re: Name of the OASIS eTMF Standard Technical Committee

Good morning Eldin,

Thank you (and Karen and Steve) for raising this concern to the Technical Committee's attention. It is an important issue. I will be at the next meeting and can help explain the options to everyone at that time.

Let me take a moment however to explain one part of the OASIS process. That is that changing the name of a TC cannot be done either under 2.11 (clarification) or 2.12 (rechartering). In section 2.12 of the TC Process (https://www.oasis-open.org/policies-guidelines/tc-process#rechartering), the second paragraph reads:

"Rechartering shall not change the TC name nor the IPR Mode of the TC. If a different name or IPR Mode is desired then a new TC (with a unique name) must be formed and the normal rules for creating a new TC apply (see section 2.2)."

Thus the only way that a TC name can be changed under OASIS rules is to close the current TC and submit a new charter with the new name and, essentially, start all over again.

What we can do with no difficulty at all is to change the short descriptive tag line associated with the TC name, the introductory sections on the TC's home page, anything really on the public facing web page. That content is under the complete control of the TC at all times and we can do anything there that will help explain the intent of the TC better.

Again, I will be at next week's meeting and can explain things further. I felt though that it would be best to make this limitation clear immediately.

Best,

/chet

On Wed, Feb 12, 2014 at 6:15 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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/chet
----------------
Chet Ensign
Director of Standards Development and TC Administration
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