TMF Reference Model (TMF RM) Steering Committee Statement on the OASIS Interoparability Initiative

The TMF Reference Model Steering Committee (SC) has been discussing eTMF interoperability in the light of recent announcements from OASIS following the establishment of an eTMF Standard Technical Committee within OASIS. Overall, we are supportive of this initiative, but with caveats as detailed below.

The TMF Reference Model provides sponsors and CROs with a reference point to help them define the content of their TMFs with recommended content definition, vocabulary and taxonomy that meets their business needs. We have considered whether the TMF Reference Model should be developed into a standard but there are significant concerns with this proposal, including the need for individual sponsors to retain flexibility in their approach to TMF content management across varying regulatory requirements globally and the absence of a definitive TMF inventory from any regulatory agency. For the time being then, the SC will not be recommending development of the Reference Model as a standard though will review the decision again in the future. This is in line with the survey done at the end of 2013 where although 97% of the respondents felt that an interoperability standard was needed, 34% of respondents felt that the TMF Reference Model itself should not be a standard. However, we confirm that industry is facing significant difficulties arising from the inability of eTMF solutions to easily exchange content with each other. In this respect, we agree that a globally recognized interoperability standard would be helpful. This should be an open source technical standard that facilitates the exchange of TMF content between eTMF systems whilst allowing a dynamic content definition, taxonomy and vocabulary.

With respect to the OASIS initiative, we have significant concerns that the TMF Reference Model is not being used as the starting material for the OASIS Technical Committee. We do not support the use of the CareLex Reference Model taxonomy and vocabulary as the starting material for the interoperability standard. We are also concerned that the activities of the OASIS Technical Committee should not be unfairly biased towards any one vendor, CRO or organization. In addition, the development of a standard with an organization that is more closely aligned with Life Sciences/Healthcare may have been more appropriate. However, we firmly believe that the initiative within OASIS provides an acceptable opportunity for the clinical community ā€“ including sponsors, CROs, vendors, sites and other interested parties ā€“ to develop a technical interoperability standard and we therefore support development of such a standard via the OASIS Technical Committee.

We believe that a usable and valuable eTMF interoperability standard would be consistent and harmonized with the TMF Reference Model and we acknowledge that the Model may require changes in the course of developing the interoperability standard. For this reason, we believe it is important for our TMF Reference Model community to be appropriately represented on the OASIS Technical Committee. As an organization, we are unable to provide official representatives for the Technical Committee but we encourage individuals to join the OASIS Technical Committee as employees of the companies they work for, particularly those who have experience and technical expertise in the management of electronic TMF documents and/or data exchange systems.

If your company is already an OASIS member, you may obtain an OASIS login and once you have a login you then join the eTMF Standard TC. If your company is not yet an OASIS member and there are multiple people who wish to participate, your company will need to join OASIS ($3,520 – $8,825, depending in the size of your company) and then each individual obtain an OASIS login and then join the eTMF TC. If you are the only employee likely to participate in your company, you may join OASIS with individual/associate membership ($1,315). Finally, if you are unemployed or a self-employed consultant, you may join as an individual ($325).

The public web page of the OASIS eTMF Standard Technical Committee can be found here.

Karen Redding (Chair), Steve Scribner (Vice-chair), Eldin Rammell (Secretary)

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Author: rammellel

Records management consultant to the life sciences / pharmaceutical industry

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