OASIS eTMF Interoperability Committee Discusses Digital Signatures

oasisThe latest meeting of the OASIS eTMF Interoperability Technical Committee convened yesterday (3rd March). The main topic on the agenda was signatures and how these should be exported from one system to another. A number of interesting – and perhaps controversial – issues were discussed. The meeting began with an overview presentation of some of the regulations pertaining to electronic and digital signatures, one of the key ones highlighted being 21CFR11. The guidance from the FDA suggests that export of records should be in common file formats such as PDF, XML or SGML. The benefits of digital signatures was highlighted by Peter Alterman from SAFE-BioPharma.
We pointed out that whilst digital signatures might be seen as “the gold standard”, 21CFR11, the FDA and EMA all permit the use of simple electronic signatures and these are widely used across industry within eTMF systems currently. It is important therefore that any eTMF interoparbility standard should not exclude this type of signature manifestation. Similarly, the discussion focussed heavily on the EMA and FDA requirements for digital signatures on documents included in submissions but these only make up a small part of TMF component (typically 45 artfacts out of the 245 in the TMF Reference Model).
There was even a question raised regarding what documents needed to be signed. It is clear this is outside the remit of the OASIS Technical Committee! It is for industry to decide what documents to sign – referring to relevant regulations – and to use whatever technology is appropriate to them. The OASIS TC then needs to ensure the standard accommodates common industry practice. In fact, the Committee did recognise that wet-ink signatures are still used widely across industry and the metadata model for interoperability needs to recognise the fact that some scanned images in eTMF systems will bear a wet-ink signature and the related file attributes are important for interoperabilty and data exchange.
On the topic of export format for documents, perhaps the Technical Committee is going ‘off piste’ again? The reference to the FDA guidelines is not referring to export of TMF content from one systen to another. The reference actually relates to the provision of TMF content for inspection purposes. Ideally, the original TMF content would be provided but the guidance note 3.4 from the FDA confirms that export of content using automated means to common file formats such as PDF, XML and SGML is permitted. Surely, when transferring TMF content from one eTMF system to another (i.e. TMF interoperability) the ideal scenario is to retain content in its original format? So if the the source eTMF system creates and maintains records in Microsoft Word, the target eTMF system would accept the content in Microsoft Word, and not in a different file format. This is not to preclude file format conversion but simply to state that an interoperability standard should not dictate the source or target file format.
If you have a view on this topic, or any other topic related to TMF interoperability, please make sure you sign up as an OASIS member and join the Technical Committee.

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 – including sponsors, CROs, vendors, sites and other interested parties – 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)