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Subject: Name of the OASIS eTMF Standard Technical Committee
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. Legal Notice: Rammell Consulting Ltd registered in England & Wales, Company No. 6171770. Registered address: 4 Knotts Ave, Worcester, WR4 0HZ, UK. |
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