Hi all,
The first Committee specification Draft is just about ready for publication, but we will need to adjust the title of the submitted Working Draft. The title as submitted is "OASIS eTMF Standard Specification Version 1.0".
The problem is that the use of the word "Standard" in the title is extremely confusing to the entire standardization process. It's a bit like calling yourself "President/Senator/etc." as soon as you have declared your candidacy.
Obviously the goal of the Technical Committee's diligent work is to produce an OASIS Standard, but until it has reached that stage of development and approval, we can't apply the word "Standard" to its title or subtitle. (Although I know that many TC members have become used to calling it "the eTMF Standard", but we can't use that nomenclature for publication purposes.)
The word "Specification" will be fine.
Also, as noted in the OASIS Naming Directives [1], "Preferably, a title should not begin with the name "OASIS" except on the recommendation of TC Administration for special cases." So, we will follow the rule here and remove the initial work OASIS.
Finally, the Naming Directives also request that acronyms "should be enclosed in parentheses, and should follow [..] the acronym expansion." This provides a much more meaningful title for anyone not already familiar with eTMF.
Based on the considerations above, unless any TC member objects, we will plan to proceed to publish your Work Product for Public Review using the title "Electronic Trial Master File (eTMF) Specification Version 1.0".
At this point, I expect that the documents can be published and the 45-day Public Review can begin at the end of the day tomorrow.
Given this relatively straightforward modification to the title, I don't anticipate any objection, but I feel that I should allow at least a day for any TC member to object. In that case, the TC will need to follow due process according to Robert's Rules, and approve a title with a motion, vote, etc., either at a meeting or through electronic ballot (which must be open for a week).
Thanks for your understanding as we work through all the technicalities to get the TC's first publication underway.
Best regards,
Paul